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Volker Schumpelick

Robert J. Fitzgibbons (Eds.)

Hernia Repair Sequelae


Volker Schumpelick
Robert J. Fitzgibbons (Eds.)

Hernia Repair
Sequelae
In Collaboration with Joachim Conze

With 236 Figures and 97 Tables

1 23
Prof. Dr. Volker Schumpelick Prof. Dr. Robert J. Fitzgibbons
Chirurgische Klinik Department of Surgery
Universitätsklinikum Aachen Creighton University
Pauwelsstraße 30 601 North 30th Street
52074 Aachen Suite 3740
Germany Omaha, NE 68131
e-mail: [email protected] USA
e-mail: [email protected]

ISBN 978-3-642-04552-3 Springer-Verlag Berlin Heidelberg New York

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V

Preface

At the last Suvretta meeting in 2006 on recurrent hernia prevention and treatment, we dem-
onstrated that with the wide range of available techniques, materials, and meshes at our dis-
posal today, an experienced hernia surgeon will be able to prevent or at least treat a recurrent
hernia.
But whereas recurrences can be treated successfully in most cases, some other hernia
repair sequelae can result in severe, sometimes untreatable problems, e.g. pain, infection, ad-
hesion, or infertility. That was the reason to focus the 5th Suvretta meeting in 2008 on hernia
repair sequelae. We are convinced that such sequelae can be a more serious problem for the
patient than the mostly treatable recurrent hernia. Therefore, it was appropriate to focus the
5th Suvretta meeting on these longterm problems.
During a four-day meeting, we discussed all technical aspects of the various operations
and materials to generate a consensus concerning the best techniques and meshes. We ex-
plored methods to improve surgical techniques to look into the multifactorial causes of post
hernia repair sequelae. In the seclusion of the Swiss plateau valley we had a perfect setting to
discuss these important hernia repair problems in detail with the top hernia specialists in the
world.
With this book, the results of this exceptional 5th Suvretta meeting have been made acces-
sible for every surgeon who is interested in hernia surgery and its sequelae.

V. Schumpelick
VII

List of First Authors

Alfieri, S. Bachman, S. L. Champault, G. G.


Department of Digestive Surgery University of Missouri Paris University XIII – Medical School
Catholic University of Sacred Heart Department of Surgery »Léonard de Vinci«
Largo Agostino Gemelli 8 Missouri Hernia Institute Department of Digestive Surgery
00168 Rome University of Missouri–Columbia University Hospital Jean Verdier
Italy 414 McHaney Hall Avenue du 14 Juillet
[email protected] Columbia, MO 65211 93140 Bondy
USA France
Amid, P. K. [email protected]
Department of Surgery Bellows, C.
David Geffen School of Medicine at Associate Professor of Surgery Chowbey, P. K.
UCLA Chief, General Surgery Minimal Access, Metabolic and
Lichtenstein Hernia Institute at Director of Surgical Research Bariatric Surgery Centre
UCLA General and Laparoscopic Surgery Sir Ganga Ram Hospital
1260 15th Street, Suite 1200 Tulane University Room No. 200 (IInd floor)
Santa Monica, CA 90404 New Orleans, LA New Delhi 110060
USA USA India
[email protected] [email protected]
Berger, D.
Arlt, G. D. Department of Surgery Conze, J.
Department of Surgery Stadtklinik Department of Surgery
Park-Klinik Weissensee Balgerstrasse 50 University Hospital RWTH
Schönstrasse 80 76532 Baden-Baden Pauwelsstrasse 30
13086 Berlin Germany 52074 Aachen
Germany [email protected] Germany
[email protected] [email protected]
Binnebösel, M.
Aufenacker, T. J. Department of Surgery Demirer, S. D.
Department of Surgery (C22) RWTH Aachen University Hospital Ankara University School of
Canisius Wilhelmina Ziekenhuis Pauwelsstrasse 30 Medicine
(CWZ) 52074 Aachen Department of Surgery
Postbus 9015 Germany Ankara
6500 GS Nijmegen [email protected] Turkey
The Netherlands [email protected]
[email protected] Bringman, S.
Clintec, Karolinska Institutet Deysine, M.
Aydede, H. Stockholm, Sweden Professor of Surgery
Associate Professor of Surgery Departments of Surgery, Södertälje Winthrop University Hospital
Celal Bayar University Medical Hospital Mineola, NY
Faculty Södertälje USA
Department of Surgery Sweden [email protected]
Manisa [email protected]
Turkey
[email protected]
VIII List of First Authors

Diaz, J. J., Jr. Flament, J. B. Hegarty, D.


Division of Trauma and Surgical Department of Surgery Department of Anaesthesia, Inten-
Critical Care Faculty of Medicine sive Care & Pain Medicine
Department of Surgery University of Reims Champagne- Cork University Hospital
Vanderbilt University Medical Ardenne Cork
Center General Surgery Service Ireland
Nashville, TN Hôpital Robert Debré [email protected]
USA Rue Serge Kochman
[email protected] 51100 Reims Honigsberg, E.
France Mount Sinai Medical Center
Dilek, O. N. [email protected] 1010 5th Avenue
Professor of General Surgery New York, NY 10028
School of Medicine Franz, M. G. USA
Kocatepe University Associate Professor of Surgery
PK:70 Chief, Minimally Invasive Surgery Hopf, H. W.
03100 Afyonkarahisar University of Michigan Department of Anesthesiology,
Turkey Department of Surgery University of Utah
[email protected] 2214F Taubman Center Medical Director, Urban Central
1500 East Medical Center Drive Region Wound Care Services
Falagas, M. E. Ann Arbor, MI 48109 LDS Hospital
Department of Medicine, Henry USA 8th Avenue and C Street
Dunant Hospital, Athens, Greece [email protected] Salt Lake City, UT 84132
Department of Medicine, Tufts USA
University School of Medicine, Goldenberg, A. [email protected]
Boston, MA, USA Associate Professor
Alfa Institute of Biomedical Sciences Department of Surgery Jansen, M.
(AIBS) Federal University of Sao Paulo Department of Surgery
9 Neapoleos Street, 151 23 Marousi Brazil University Hospital
Athens, Greece [email protected] RWTH Aachen
[email protected] Pauwelsstrasse 30
Gryska, P. vR. 52074 Aachen
Fawole, A. S. Tufts University School of Medicine Germany
Department of Academic Surgery Boston, MA [email protected]
St. James’s University Hospital Department of Surgery
Beckett Street Newton-Wellesley Hospital Jansen, P. L.
Leeds LS9 7TF Suite 365, 2000 Washington Street Department of Surgery
UK Newton, MA 0246 University Hospital
[email protected] USA RWTH Aachen
[email protected] Pauwelsstrasse 30
52074 Aachen
Hansson, B. Germany
Department of Surgery [email protected]
Canisius Wilhelmina Hospital
Nijmegen
The Netherlands
IX
List of First Authors

Junge, K. Kolbe, T. Montgomery, A.


Department of Surgery Biomodels Austria, University Department of Surgery
Technical University of Aachen of Veterinary Medicine Malmö University Hospital
Pauwelsstrasse 30, Veterinärplatz 1 20502 Malmö
52057 Aachen 1210 Vienna Sweden
Germany Austria [email protected]
[email protected] [email protected]
Morales-Conde, S.
Kaemmer, D. Kukleta, J. F. University Hospital Virgen del Rocío.
Department of Surgery Klinik Im Park Betis-65, 1º
RWTH Aachen Seestrasse 220 41010 Sevilla
Pauwelsstr. 30 8027 Zurich Spain
52074 Aachen Switzerland [email protected]
Germany [email protected]
[email protected] Muschaweck, U.
Kurzer, M. Hernienzentrum Dr. Muschaweck –
Kavvadias, T. British Hernia Centre München
Department of Obstetrics and 87 Watford Way Arabellastrasse 5
Gynaecology London NW4 4RS 81925 Munich
Lucerne Cantonal Hospital UK Germany
Lucerne [email protected] [email protected]
Switzerland
Lammers, B. J. Neumayer, L.
Kehlet, H. Department for Colorectal and Professor of Surgery
Section for Surgical Patho- Hernia Surgery Department of Surgery
physiology 4074 Lukaskrankenhaus Neuss University of Utah
Rigshospitalet Copenhagen Neuss Salt Lake City VA Healthcare System
University Germany 1950 Circle of Hope Room 6540
Blegdamsvej 9 [email protected] Salt Lake City, UT 84132
2100 Copenhagen USA
Denmark Matthews, B. D. [email protected]
[email protected] Chief, Section of Minimally Invasive
Surgery Nordin, P.
Klinge, U. Department of Surgery Head of the Swedish Hernia Register
Institute for Applied Medical Washington University School of Department of Surgery
Engineering Medicine Östersund Hospital
Helmholtz Institute for Applied 660 S. Euclid Ave., Campus Box 8109 831 83 Östersund
Medical Technology St. Louis, MO 63110 Sweden
RWTH Aachen University USA [email protected]
Pauwelsstraße 20-30 [email protected]
52074 Aachen Otto, J.
Germany Miserez, M. Department of Surgery
[email protected] Department of Abdominal Surgery University Hospital
University Hospitals RWTH Aachen
Herestraat 49 Pauwelsstrasse 30
3000 Leuven 52074 Aachen
Belgium Germany
[email protected] [email protected]
X List of First Authors

Page, B. P. Schug-Paß, C. Stroh, C.


University Department of Surgery Department of Surgery Department of General, Abdominal
Western Infirmary Center for Minimally Invasive and Paediatric Surgery
Glasgow G11 6NT Surgery Municipal Hospital (Teaching
Scotland Vivantes Hospital Spandau Hospital of the Friedrich-Schiller
[email protected] Neue Bergstrasse 6 University at Jena, Germany)
13585 Berlin Strasse des Friedens 122
Pascual, G. Germany 07548 Gera
Department of Medical Specialities [email protected] Germany
Alcalá University [email protected]
Networking Research Centre on Schumpelick, V.
Bioengineering, Biomaterials and Department of Surgery Stumpf, M.
Nanomedicine (CIBER-BNN) University Hospital RWTH Department of Surgery
Madrid Pauwelsstrasse 30 RWTH Aachen
Spain 52074 Aachen Pauwelsstrasse 30
Germany 52074 Aachen
Peiper, C. [email protected] Germany
Surgical Clinic michale.stumpf@
Evangelisches Krankenhaus Simons, M. P. klinikum-pforzheim.de
Werler Strasse 110 Department of Surgery
58455 Hamm Onze Lieve Vrouwe Gasthuis van der Kolk, B. M.
Germany Postbus 95500 Department of Surgery, Division of
[email protected] 1090 HM Amsterdam Abdominal Surgery
The Netherlands Radboud University Nijmegen
Penkert, G. [email protected] Medical Center
Friederikenstift Hannover Nijmegen
Department of Neurosurgery Smeds, S. The Netherlands
Humboldtstrasse 5 The Sergel Clinic
30169 Hannover Department of Clinical and Experi- Witkowski, P.
Germany mental Medicine Department of Surgery
[email protected] Faculty of Health Sciences Division of Abdominal Organ
University Hospital Transplantation
Read, R. C. Linköping University Columbia University
Emeritus Professor of Surgery 58185 Linköping 177 Fort Washington Ave,
304 Potomac Street Sweden 7HS, Room 200C
Rockville, MD 20850 [email protected] New York, NY 10032
USA USA
[email protected] Stanton-Hicks, M. [email protected]
Vice Chairman, Anesthesiology
Schippers, E. Institute
Surgical Clinic Consulting Staff, CCF Shaker
Department of General and Visceral Children’s Pain Rehabilitation
Surgery Cleveland Clinic
Juliusspital Pain Management Department
Juliuspromenade 19 9500 Euclid Avenue – C-25
97070 Würzburg Cleveland, OH 44195
Germany USA
[email protected] [email protected]
XI

Contents

15 Fate of the Inguinal Hernia Following


I Risk for the Spermatic Cord Removal of Infected Prosthetic Mesh . . . . . . .113
16 Mesh Infection–Therapeutic Options . . . . . . .119
17 Does Antibiotic Prophylaxis Prevent the
1 Are There Adverse Effects of Herniorrhaphy Occurrence of Wound Infection After Groin
Techniques on Testicular Perfusion? . . . . . . . . . . 3 Hernia Surgery? . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
2 The Effects of Mesh Bioprosthesis 18 Infection Control in a Hernia Clinic:
on the Spermatic Cord Structures in a 24-Year Results of Aseptic and Antiseptic
Rat Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Measure Implementation in 4,620 »Clean
3 Damage to the Spermatic Cord by the Cases« Based on Up-To-Date Micro-
Lichtenstein Procedure in a Pig Model– biological Research . . . . . . . . . . . . . . . . . . . . . . . .135
Preliminary Results . . . . . . . . . . . . . . . . . . . . . . . . . . 21 19 Components Separation Technique:
4 Influence of Prosthetic Implants on Male Pros and Cons . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Fertility in Rabbits and Rats . . . . . . . . . . . . . . . . . 29
5 The Effects of a Mesh Bioprosthesis on
the Spermatic Cord Structures . . . . . . . . . . . . . . 39
6 Influence of Prosthetic Implants on Male III Risk for Pain
Fertility in Rats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7 What Can We Do To Decrease the Risk
of Vas Deferens Injury due to Inguinal 20 Self-Assessment of Discomfort and Pain
Hernioplasty? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 after Inguinal Hernia Repair: A Reflection
8 The Long-Term Effect on Testicular of Both Individual Pain Propensity and
Function of a Mesh Bioprosthesis Used for Surgical Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Inguinal Hernia Repair . . . . . . . . . . . . . . . . . . . . . . 57 21 Chronic Pain After Inguinal Hernia Repair . . .163
9 Reoperation Following Lichtenstein Repair: 22 What Do We Know About the Patho-
What Do Vas and Nerves Look Like? . . . . . . . . . 65 physiology and Pathology of Neuropathic
10 Damage to the Spermatic Cord from Pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169
Groin Herniorrhaphy: A Review . . . . . . . . . . . . . . 71 23 Surgical Trauma of Nerves–Causes of
Neuropathic Pain, Classification, and
Options in Surgical Therapy . . . . . . . . . . . . . . . .177
24 Risks for Pain–Neuropathic Pain:
II Risk for Infection How Should We Handle the Nerves? . . . . . . . .185
25 What To Consider as Clinicians About
Chronic Postoperative Pain and Inguinal
11 Mesh Infection Following Hernia Repair: Herniorrhaphy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191
A Frequent Problem? . . . . . . . . . . . . . . . . . . . . . . . 79 26 Risk Factors for Chronic Pain After
12 Patient Factors as a Major Determinant Groin Hernia Surgery . . . . . . . . . . . . . . . . . . . . . .199
of Wound Outcome and Infection After 27 Ischemic Inflammatory Response
Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Syndrome as an Alternative Explanation
13 Mesh-Related Infections After Hernia for Postherniorrhaphy Pain . . . . . . . . . . . . . . . . .207
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 28 Postoperative CRPS in Inguinal Hernia
14 Human Acellular Dermal Matrix for Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213
Ventral Hernia Repair in the Compromised 29 Chronic Pain After Open Mesh Repair
Surgical Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103 of Incisional Hernia . . . . . . . . . . . . . . . . . . . . . . . .221
XII Contents

30 Clinical Results After Open Mesh Repair . . . .227 47 Effect of Different Mesh Materials on
31 Acute and Chronic Pain After Laparoscopic Adhesion Formation . . . . . . . . . . . . . . . . . . . . . . .353
Incisional Hernia Repair . . . . . . . . . . . . . . . . . . . .233 48 Tissue Ingrowth and Laparoscopic
32 Effect of Nerve Identification on the Rate Ventral Hernia Mesh Materials: An Updated
of Postoperative Chronic Pain Following Review of the Literature . . . . . . . . . . . . . . . . . . . .365
Inguinal Hernia Surgery . . . . . . . . . . . . . . . . . . . .239 49 Porosity and Adhesion in an IPOM
33 Discomfort 5 Years After Laparoscopic Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .375
and Shouldice Inguinal Hernia Repair: 50 Benefit of Lightweight and/or Titanium
A Report from the SMIL Study Group . . . . . . .245 Meshes? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .381
34 Recurrence or Complication: The Lesser 51 ePTFE Prostheses and Modifications . . . . . . . .393
of Two Evils? A Review of Patient-Reported 52 The Role of Stem Cells in Abdominal
Outcomes from the VA Hernia Trial . . . . . . . . .251 Wall Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .401
35 Chronic Pain After Inguinal Hernia
Repair: The Choice of Prosthesis
Outweighs That of Technique . . . . . . . . . . . . . .257
36 The Effect of Polypropylene Mesh on V Risk for Migration and
the Ilioinguinal Nerve in Open Mesh Erosion
Repair of Groin Hernia . . . . . . . . . . . . . . . . . . . . .265
37 Lightweight Macroporous Mesh vs.
Standard Polypropylene Mesh in 53 Safety and Durability of Prosthetic Repair
Lichtenstein Hernioplasty . . . . . . . . . . . . . . . . . .275 of the Hiatal Hernia: Lessons Learned from
38 Does the Choice of Prosthetic Mesh Type a 15-Year Experience . . . . . . . . . . . . . . . . . . . . . . .413
Make a Difference in Postherniorrhaphy 54 Mesh Migration into the Esophageal
Groin Pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .279 Wall After Mesh Hiatoplasty . . . . . . . . . . . . . . . .421
39 New Understanding of the Causes and 55 Complications After Gastric Banding–
Surgical Treatment of Postherniorrhaphy Results in Germany . . . . . . . . . . . . . . . . . . . . . . . .429
Inguinodynia and Orchialgia . . . . . . . . . . . . . . .287 56 Alloplastic Implants for the Treatment
40 Surgery for Chronic Inguinal Pain: of Stress Urinary Incontinence and Pelvic
Neurectomy, Mesh Explantation, or Both? . . . 293 Organ Prolapse . . . . . . . . . . . . . . . . . . . . . . . . . . . .439
41 Results of Tailored Therapy for Patients 57 Prophylactic IPOM Mesh To Prevent
with Chronic Inguinal Pain . . . . . . . . . . . . . . . . .299 Parastomal Hernias . . . . . . . . . . . . . . . . . . . . . . . .445
58 Laparoscopic Parastomal Hernia Repair:
Pitfalls and Complications . . . . . . . . . . . . . . . . . .451
59 Concept of Visible Mesh and Possibili-
IV Risk for Adhesion ties for Analysis of Mesh Migration and
Shrinkage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .457

42 Adhesion as a Chronic Inflammatory


Problem? Risk for Adhesions, Migration,
and Erosions? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .305 VI Strategy to Improve Results
43 Biological Tissue Graft: Present Status . . . . . .317
44 IPOM Results of 344 Consecutive Patients
with a PVDF-Derived Prosthesis . . . . . . . . . . . . . 323 60 Who Has the Major Role in Hernia Surgery:
45 Pooled Data Analysis of Laparoscopic vs. The Surgeon or the Material? . . . . . . . . . . . . . . .463
Open Ventral Hernia Repair: 14 Years of 61 Two Controversial Concepts: Standard
Patient Data Accrual . . . . . . . . . . . . . . . . . . . . . . .331 Procedure in a Standard Patient Versus
46 Tissue Ingrowth, Adhesion, and Mesh Tailored Surgery with Procedures Adjusted
Contraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .345 to Individual Patients . . . . . . . . . . . . . . . . . . . . . .467
XIII
Contents

VII Pro and Contra

62 In Support of a Standard Technique for


Inguinal Hernia Repair . . . . . . . . . . . . . . . . . . . . .475
63 In Support of Individual Selection of
Technique as Related to the Patient–
Improvement by Better Selection of
Patients Who Can Be Offered a Less Risky
Technique: Groin Hernia . . . . . . . . . . . . . . . . . . .479
64 In Support of Standard Procedure in
Abdominal Hernia Repair . . . . . . . . . . . . . . . . . .485
65 In Support of Individualized Procedures
in Abdominal Wall Hernia Repair . . . . . . . . . . .493
66 In Support of Standard Procedure in
Hiatal Hernia Repair . . . . . . . . . . . . . . . . . . . . . . . .503
67 Strategy To Improve the Results?
In Support of Individualized Procedures
in Hiatal Hernia Repair . . . . . . . . . . . . . . . . . . . . .513

68 Questionnaire . . . . . . . . . . . . . . . . . . . . . . . . . . . . .521

Subject Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .525


I

I Risk for the Spermatic Cord

1 Are There Adverse Effects of Herniorrhaphy Techniques


on Testicular Perfusion? – 3

2 The Effects of Mesh Bioprosthesis on the Spermatic


Cord Structures in a Rat Model – 13

3 Damage to the Spermatic Cord by the Lichtenstein


Procedure in a Pig Model–Preliminary Results – 21

4 Influence of Prosthetic Implants on Male Fertility


in Rabbits and Rats – 29

5 The Effects of a Mesh Bioprosthesis on the Spermatic


Cord Structures – 39

6 Influence of Prosthetic Implants on Male Fertility in Rats – 43

7 What Can We Do To Decrease the Risk of Vas Deferens Injury


due to Inguinal Hernioplasty? – 49

8 The Long-Term Effect on Testicular Function of a Mesh


Bioprosthesis Used for Inguinal Hernia Repair – 57

9 Reoperation Following Lichtenstein Repair:


What Do Vas and Nerves Look Like? – 65

10 Damage to the Spermatic Cord from Groin Herniorrhaphy:


A Review – 71
1

Are There Adverse Effects


of Herniorrhaphy Techniques
on Testicular Perfusion?
O. N. Dilek
4 Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?

Introduction with testicular dysfunction [1, 3]. At the level of


1 the inguinal canal, the vein joins to form two or
The spermatic cord anatomy has been well studied three channels and then a single vein that drains
because of its important role in testicular physiology into the inferior vena cava on the right and the
and surgery. The spermatic cord is composed of the renal vein on the left [1, 5].
vas deferens; testicular vessels, including the testicu- The cremasteric muscle is one of the parts of
lar artery and veins; autonomous nerves; spermatic the spermatic cord. When this muscle contracts,
muscle; and fascia [1]. Each of these structures can the cord is shortened, and the testicle is moved
have various effects on testicular perfusion. closer up toward the body, a position that pro-
The testicular arteries arise from the abdomi- vides slightly more warmth to maintain optimal
nal aorta just below the renal artery and travel in testicular temperature. When cooling is required,
the intermediate stratum of the retroperitoneum the cremasteric muscle relaxes, and the testicle is
to reach the internal inguinal ring and become a lowered away from the warm body and is able to
component of the spermatic cord [1]. In an intra- cool. This phenomenon is known as the cremas-
operative dissection study of over 100 spermatic teric reflex [6]. The dartos muscle is a sympatheti-
cords, Beck et al. identified a single internal sper- cally innervated dermal muscle layer within the
matic artery in 50% of cases, with two arteries in scrotum, distinct from the somatically innervated
30% of spermatic cords and three arteries in 20% cremasteric muscle. Abnormalities of dartos and
[1]. At the internal ring, the vessels are joined cremasteric muscle innervation may impact testis
by the genital branch of the genitofemoral nerve, thermoregulation and spermatogenesis [6].
the ilioinguinal nerve, the cremasteric artery, the Autonomous nerves reach the testis accom-
vas deferens, and its artery. The testicular artery panying the testicular artery and pampiniform
branches into an internal artery and an inferior plexus. The vast majority of testicular nerves are
testicular artery and into a capital artery to the sympathetic axons with vasomotor function. They
head of the epididymis [1]. Human testicular pa- innervate the small vessels supplying clusters of
renchyma receives approximately 9 ml of blood Leydig cells and regulate testicular luteinizing hor-
per 100 g of tissue per minute. Silber showed that mone receptors and blood flow [7, 8].
an interruption of the testicular blood supply may About 10% of people develop some type of her-
result in testicular atrophy [2]. nia during their lifetime, and more than 750,000
The spermatic veins (testicular veins) collect hernia operations are performed in the United
the blood from the testis, epididymis, and scrotum. States each year. Hernias are seven times more
The testicular veins form several highly anasto- common in males than in females [9]. Abramson
motic channels that surround the testicular artery et al. reported that the overall current risk for a
as the pampiniform plexus. This arrangement al- male to have an inguinal hernia is 18%, and the
lows countercurrent heat exchange, which cools lifetime risk is 24% [10].
the blood in the testicular artery [1]. The vascular Anatomically, a close relation exists between
arrangement in the pampiniform plexus–with the the spermatic cord and inguinal hernias. Inguinal
counterflowing artery and veins separated only by hernias can carry the risk of ischemia of the testis
the thickness of their vascular wall in some areas– by intermittent mechanical compression (pressure)
facilitates the exchange of heat and small mol- on the testicular vessels [11, 12]. In some reports,
ecules. For example, testosterone is transported color Doppler ultrasonography showed that, pre-
from the vein to the artery via a concentration- operatively, the sonographic resistive index (RI)
limited passive diffusion process. The counter- was significantly elevated in the affected (hernia)
current exchange of heat in the spermatic cord side compared with the normal side [13]. On
provides blood to the testis, which is a specialized the other hand, Muñoz Sánchez et al. concluded
structure that functions optimally at 2–4°C lower that uncomplicated inguinal hernias cause no sig-
than the rectal temperatures in normal men [3, 4]. nificant alterations in the arterial circulation of the
A loss of the temperature differential is associated testicle [14].

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Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?
5 1
The laparoscopic totally extraperitoneal prep- Materials and Methods
eritoneal (TEP) hernia repair technique, which is
based on the concept of tension-free high ligation In our prospective randomized series of 82 pa-
of the sac, has become widely popular in surgical tients, 26 of them (age 24–71 years) fulfilled the
practice [15–18]. Lichtenstein hernia repair (LHR) inclusion criteria and underwent elective hernior-
is one of the most comfortable effective methods of rhaphy for groin hernia [26].
inguinal hernia repair, and it has similarities with In patients with an American Society of Anes-
TEP because of the prosthetic mesh used [19]. thesiologists (ASA) score of more than II, having
Despite the frequency of open and laparoscopic a hydrocele and/or a varicocele could alter the tes-
herniorrhaphy, the effects of a hernia and its sub- ticular function independent of the hernia repair
sequent repair on testicular perfusion and function [27, 28]. For this reason, patients with the follow-
are unknown. It is presently unclear what the best ing conditions were excluded from the study: her-
method is for reconstructing the deep inguinal nia types Ia, IIb, III, or IV according to the Nyhus
ring in hernia surgery with mesh implantation. classification [16, 29]; ASA scores of III, IV, or V;
Testicular dysfunction (atrophy) is one of the or hydrocele and/or varicocele. Other exclusion
most dreaded sequelae of inguinal hernioplasty. criteria were recurrence, conversion to an open
However, literature findings show that testicular procedure, or the inability to provide informed
atrophy occurs in 0–2% of patients after hernior- consent. Scrotal hernias or large hernias are pre-
rhaphy [9, 20]. Yavetz et al. reported that among disposing factors for testicular atrophy (type IIb
8,500 patients attending a fertility clinic because of or larger), and very small hernias (type Ia) are not
infertility, 565 men (6.65%) reported an incidence suitable for TEP or LHR methods. Thus, giant
of inguinal hernioplasty with or without subse- scrotal hernias were also excluded in our study
quent atrophy of the testis [21]. [26]. Each patient was randomly assigned to one
The preoperative and postoperative use of of two groups: TEP (n=13, mean age 46.7±1.6
color Doppler ultrasound (CDUS) to evaluate the years) or LHR (n=13, mean age 54.2±2.7 years).
spermatic cord structure and scrotal structure has Six of the patients had bilateral hernias (n=3 for
been well documented in testicular pathologies each group).
and hernias [22–24]. CDUS is extremely helpful CDUS of the testes was performed on all pa-
in all cases to investigate extratesticular vascular- tients the day before operation and 3 months af-
ization and testicular perfusion, with parameters ter operation. The scrotum was examined with
optimized to display low-flow velocities, includ- a linear (5 MHz) transducer (ATL Ultramark 9,
ing peak systolic velocity (PSV) and end diastolic USA). Color Doppler settings were optimized to
velocity (EDV). Lefort and colleagues showed that detect slow flow, with the highest color gain set-
color Doppler examination of the scrotum should ting allowing an acceptable signal-to-noise ratio,
include measurement of intratesticular RI, as an the lowest wall filter, and the lowest velocity scale.
elevated RI can be suggestive of ischemia [25]. Ultrasound of the scrotum was performed in the
However, most of these conditions have not been supine position, and the patient was asked to hold
well documented using CDUS after TEP or LHR. the penis suprapubically. Blood flow parameters of
We have discussed the previously unreported use the spermatic artery were evaluated and noted as
of testicular CDUS in patients who underwent PSV, EDV, and calculated RI.
TEP or LHR. The investigation protocol was approved by
Damage to the spermatic cord structures, tes- the ethics committee of our institution. Patient
ticular atrophy, and dysfunction levels as a conse- groups were compared with each other, and the
quence of mesh application are not well known in nonoperated side was compared with the op-
adults. The purpose of this study was to evaluate erated side. Kruskal–Wallis and Mann–Whitney
the efficacy of prosthetic meshes on testis perfu- U–tests were used to evaluate the differences. A
sion and testis volume with Lichtenstein and TEP two-sided p-value <0.05 was considered signifi-
hernia repair techniques. cant [26].
6 Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?

Results
⊡ Table 1.1. Peak systolic velocity (PSV), end diastolic
1 velocity (EDV), and resistive index (RI) measurements
In our series, the mean patient age was 49.6±1.7 in the totally extraperitoneal group (NS not significant)
(range 24–71) years; in the LHR group, 54.2±2.6
Preoperative Postoperative p
(range 26–71) years; and in the TEP group,
46.7±1.7 (range 32–62) years. We found no sig- PSV 18.18±1.03 17.84±1.11
nificant changes in blood flow parameters (PSV, NS
EDV 6.68±0.48 6.07±0.37
EDV, RI) when comparing the two groups pre-
operatively and postoperatively (⊡ Tables 1.1 and RI 0.62±0.017 0.63±0.018
1.2). Also, there were no significant changes in the
blood flow parameters when the TEP and LHR
groups were compared with each other [26]. ⊡ Table 1.2. Peak systolic velocity (PSV), end diastolic
velocity (EDV), and resistive index (RI) measurements
in the Lichtenstein repair group (NS not significant)
Discussion
Preoperative Postoperative p

All inguinal hernia repair techniques aim to close PSV 17.30±0.98 17.24±0.78
the internal ring with a suture or a biomaterial NS
EDV 5.51±0.29 5.70±0.29
such as polypropylene mesh. Concern has been
raised about whether the spermatic cord structures RI 0.65±0.017 0.66±0.014
are compromised with these techniques
The spermatic cord structures may be exposed
to invasive surgical intervention during inguinal However, many authors have reported that the
hernia reconstruction. Surgical dissection, divi- testes have more vessels than expected. Testicular
sion, or mechanical trauma to the spermatic artery arterial anatomy has been well studied because of
and veins accounts for serious trophic changes its important role in testicular physiology and tes-
in the testis. Lee et al. have explained that surgi- ticular surgery. Anatomically, the spermatic artery
cal manipulation of the spermatic cord imparts divides into two branches near the testis. Jarow
a small but statistically significant morphological et al. showed that the frequent early branching of
change in testicular size without a deleterious ef- the internal spermatic artery prevents inadvertent
fect on testicular development, fertility, or fecun- interruption of testicular arterial blood flow dur-
dity [20]. ing operations performed on the spermatic cord
Many factors can lead to decreased or inter- within the inguinal canal [31]. The testicular ar-
rupted testicular perfusion. In some reports, ingui- tery penetrates the tunica albuginea at the lower
nal hernia may impair testicular blood flow, which pole, proceeding as the capsular artery. Using
may be attributable to the effect of intermittent me- CDUS, a transmediastinal artery is visible in the
chanical compression on the funiculus spermaticus upper third of the testis in 50%. Branches from the
in the inguinal canal [11–13, 25]. Testicular artery capsular artery course through the parenchyma in
and vein injuries, thrombosis of the spermatic vein the testicular septations as afferent arteries and are
plexus, and testicular torsion are the major factors directed to the gonadal hilum. The testicular veins
influencing testicular perfusion. Furthermore, the are not consistently visible with CDUS [23].
implantation of a nonabsorbable polypropylene Many studies suggest an unknown or alter-
mesh during hernia repair causes a chronic foreign native (collateral) connection between vessels of
body reaction involving the surrounding tissue. the cord and other vessels that supply blood to
In cases of inguinal hernia repair using different the testis [14, 32–34]. Zomorrodi and Buhluli
mesh techniques, the spermatic cord structures are explained that they isolated and ligated the sper-
potentially affected by this chronic inflammatory matic cord at the internal ring of the inguinal
tissue remodeling [30]. canal for transfixation and placed the allografted

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Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?
7 1

Ischemic
orchitis
Thrombosis
Ligating /Cutting
Testicular
Hematoma
ischemia
Inflammation
Fibrosis

Testicular
atrophy ⊡ Fig. 1.1. Ischemic conditions and
their relationship to testicular per-
fusion and testicular atrophy

kidney in the retroperitoneal position with anas- Testis perfusion can be maintained for a prolonged
tomoses of the iliac vessels, and that mass ligation period in the presence of testicular torsion. Ana-
of the spermatic cord did not lead to any ischemic tomical variability may account for differences in
problems in the follow-up period [33]. Zát’ura et the duration of viability of the torsed testis [37]. It
al. concluded that in the great majority of men, is clear that impairment of testicular perfusion can
the blood supply of the testis is ensured by collat- lead to testicular damage (atrophy). Other causes
eral circulation [34]. also exist, such as obstruction of the vas deferens,
It is well known that thrombosis, ligation, and/ inguinal hematoma, infections, and immunologi-
or cutting of the spermatic vessels may lead to cal reactions [21, 38].
ischemia, ischemic orchitis, and testicular atrophy For about 25 years, the use of prosthetic ma-
(⊡ Fig. 1.1). Ischemic orchitis typically presents 2–3 terials for repairing inguinal hernias has been
days after inguinal hernia surgery and can prog- routine in general surgery. An estimated 80%
ress to infarction. This ischemic injury is likely of inguinal hernia operations involve placement
due to thrombosis of the venous plexus rather of a prosthetic mesh to form a »tension-free«
than to iatrogenic arterial injury or inappropri- herniorrhaphy. The prosthetic mesh induces a
ate closure of the inguinal canal [32]. Venous chronic foreign body fibroblastic response, creat-
outflow obstruction secondary to thrombosis of ing scar tissue that imparts strength to the floor
the pampiniform plexus can also cause testicular and leads to fewer recurrences [38]. The use of
infarction as a result of overzealous dissection of prosthetic materials for inguinal hernia markedly
the cord or excessive use of diathermy; it may also reduces the recurrence rates, postoperative hospi-
be the result of pressure from a large hematoma in tal stay, pain, and discomfort. But the prosthesis
the groin [35]. frequently adheres to the cord structures in most
Testicular torsion significantly reduces testicu- cases. The disadvantages include local wound
lar vascular perfusion. Turner et al. reported that complications, technical difficulties in hernia re-
in an experimental study, experimental torsion pair, restriction of mobility by the rigid shell
significantly reduced testicular vascular perfusion. (⊡ Fig. 1.2), contraction of the mesh, and com-
Five minutes after torsion repair, the mean flow plications related to the cord structures, such as
values had returned to approximately 70% of the varicocele, hydrocele, ischemic orchitis, testicular
pretorsion values. Testicular torsion significantly atrophy, and, finally, infertility [39].
reduced the venous plasma testosterone concen- In our study, we aimed to study the effects of
trations at both 3 and 30 days after torsion repair. the TEP and LHR techniques on testicular circu-
These authors suggest that reperfusion/oxidative lation [26]. We did not find any significant dif-
stress may play a role in Leydig cell dysfunction, as ferences between the techniques regarding blood
well as acting directly in germ cell apoptosis [36]. flow in the testes. Our previous report included
8 Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?

⊡ Fig. 1.2. Prosthetic mesh induces


a chronic foreign body reaction
involving the surrounding tissue
and the spermatic cord structures,
which could impair testicular perfu-
sion and lead to testicular atrophy

the same population, and neither TEP nor LHR trapped or obliterated the testicular vessels and
affected testicular function; TEP did decrease tes- vas deferens [30, 38]. Peiper et al. [45] reported
ticular volume, but by normal limits [40]. that implantation of a nonabsorbable polypropyl-
The influence of the Lichtenstein and Shoul- ene mesh in the inguinal region during hernia
dice operations on the cord structures was inves- repair causes a chronic foreign body reaction in-
tigated in a canine model. Similar to our results, volving the surrounding tissue and the spermatic
no significant differences with regard to testicu- cord structures in pigs. They observed that venous
lar volume and blood flow were found between thrombosis of the spermatic veins occurred in
the operation groups or between the preoperative five of 15 cases. The mesh repair may also lead to
and postoperative results [41, 42]. Many clinical decreases in arterial perfusion, testicular tempera-
studies have reported similar results in which the ture, and the rate of regular spermatogenesis in
choice of either the Lichtenstein or TEP hernia seminiferous tubules. Therefore, they recommend
repair technique did not significantly alter tes- strict indications for implanting a prosthetic mesh
ticular function. Patients with inguinal hernia have during inguinal hernia repair [45].
an elevated testicular vascular resistance, which is Prosthetic meshes can contract by 20–75% of
reversed after repair. The choice of laparoscopic their original size within a year after implanta-
or open herniorrhaphy did not affect reversal of tion in the inguinal region. Taylor et al. set out to
this surrogate of testicular function [13, 42, 43]. determine whether this contraction has any effect
Laparoscopic inguinal hernia repair using suture on testicular or femoral vessel blood flow follow-
closure of the internal inguinal ring does not im- ing open or laparoscopic hernia repair. They found
pair testicular perfusion. Advantages of the laparo- that mesh contraction following inguinal hernio-
scopic approach also include its technical ease and plasty does not adversely affect the testis or femo-
the fact that it is an outpatient procedure, the cord ral vessels and that mesh can be used safely for
structures remain untouched, the type of hernia is both anterior and preperitoneal approaches [46].
obvious, and clear visualization of the anatomy can With Doppler, the flow in the spermatic ar-
be achieved [44]. tery and testicular artery and its branches is of
However, some clinical and experimental low resistance, with a relatively broad systolic part
studies revealed a dense fibroblastic response en- and holodiastolic flow. CDUS enables a defini-
compassing the polypropylene mesh that either tive diagnosis of ischemia and decreased testicular

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Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?
9 1
circulation. A pitfall to remember in the diagnosis Preperitoneal repairs should be considered for
is that hypervascularity can occur [47]. Testicu- repairs of recurrent hernias, not only to reduce
lar and epididymal swelling along with a slightly further recurrences but also to avoid testicular
decreased echogenicity have been reported to de- complications [53].
velop in the first hours, although in most cases Using an intraperitoneal composite mesh onlay
the hypoechogenicity occurs later, so examining and assuring safe fixation with fibrin glue could be
the testis 3 months after the operation seems to be an alternative when treating recurrent and compli-
more rational, as was done in our study [48, 49]. cated inguinal hernias [54].
There are many clinical and experimental In conclusion, neither TEP nor LHR affected
study results concerning whether testicular perfu- testicular circulation in our study [26]. The total
sion is adversely affected. We thought it would be number of patients in our study was a limitation.
difficult to impair testicular perfusion after hernia It is clear that fine surgical dissection and recon-
repair because of the rich arterial supply and col- struction with respect for anatomy and the use of
lateral capacity. Arterial input and venous drainage proper prosthetic material could lead to the best
of the testis are assured by many anastomoses that results. To be consistent, future animal and clinical
protect it from ischemic injury [50–52]. Careful studies must be performed in large groups and fo-
dissection and preservation of the vessels are im- cus on the use of mesh, which may increase the in-
portant to protect these anastomoses during her- tensity of the mesh reaction to the cord structures.
nia repair. The idea that deep ring repair that is too
tight may cause testicular ischemia is erroneous.
There are also many ways to protect testicular References
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hancement of the inhibitory effect obtained by »artificial
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wound, and concomitant scrotal surgery should be ductive physiology. In: Wein AJ (ed) Campbell–Walsh urol-
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11 1
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Discussion

Fitzgibbons: Your technique with color Doppler


is very good, investigating the circulation of the
testis. How good is it for testing the venous?
Dilek: I don’t have additional information about
that because this part of the study was done by the
radiologist.
Smeds: At first, do you have an idea if there is a
change of the testicular temperature, and second,
do you know if there is a connection between de-
crease of temperature and sperm production?
Dilek: That was not our topic, so I can’t give you
more information about that.
Schumpelick: How can we decide about testicular
function that may be influenced by this method if
we don’t analyze the function? I mean, tempera-
ture is not a function.
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2

The Effects of Mesh Bioprosthesis


on the Spermatic Cord Structures
in a Rat Model
A. Montgomery and F. Berndsen
14 Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model

Introduction body reaction resulting from the use of mesh that


comes into contact with the spermatic cord.
According to the Swedish Hernia Register [1], Bilateral hernia surgery in children is a known
2 an estimated 80% of inguinal hernia operations risk factor for infertility [9]. In men investigated
involve placement of a polypropylene mesh, with for infertility, 6.4% are reported to have had an iat-
a majority performed as a Lichtenstein procedure. rogenic injury to the vas after hernia surgery [10].
The Lichtenstein technique is regarded as the gold To try to minimize some of the inflammatory
standard in Sweden; this is probably in accordance effects, a composite mesh has been introduced that
with most other countries. contains 61% absorbable (polyglactin) and 39%
A prosthetic mesh induces a chronic foreign nonabsorbable material (polypropylene; Vypro II).
body reaction with fibroblastic ingrowth into the The total weight of polypropylene is 32 g/m2. The
mesh and subsequent scar plate formation. This aim of this study was to compare a heavyweight
is believed to reinforce the abdominal wall and polypropylene mesh with a lightweight composite
thereby decrease the risk of recurrence by 50–70% mesh to note the effect on spermatic cord struc-
[2]. The foreign body reaction leads to chronic tures and testosterone production in an experi-
inflammation, which can cause retraction of the mental setting.
mesh area and shrinkage of the scar plate. As a
result, tension can be put to the anchoring points
of the mesh, which might cause chronic pain. Materials and Methods
Patients might also have individual reactions to
meshes with different properties. These might be Thirty male Sprague Dawley rats were randomly
some of the factors causing chronic pain in up to divided into three groups. A 3-cm long incision
15–30% of patients operated on for inguinal her- was made in the groin, and the spermatic cord was
nias in whom mesh is used [3, 4]. exposed and dissected free. The cremaster muscle
It has been suggested that the foreign body was split but not divided.
reaction is proportionate to the weight and struc- In group I, a suture repair was performed us-
ture of the mesh and that commonly used meshes ing 5.0 polypropylene sutures (Prolene, Ethicon,
contain too much material, producing an exag- Somerville, NJ, USA) in the transversalis fascia,
gerated response [5, 6]. To minimize these effects, imitating open suture repair.
composite meshes have been introduced that con- In group II, a 2×3.5-cm heavyweight polypro-
tain one absorbable and one nonabsorbable part. pylene mesh (Prolene, Ethicon, Somerville, NJ,
By the use of composite meshes, the reinforcement USA) was placed, imitating the Lichtenstein repair.
and manageability properties desired at operation A slit was made in the mesh for the spermatic
and in the early phase can thereby be satisfied cord. The mesh was fixed with 5.0 Prolene sutures,
together with a reduction in the total amount of and the tails were approximated with one suture.
mesh left permanently in the patient. In group III, a large-pore lightweight poly-
Problems other than chronic pain that might propylene/polyglactin composite mesh, Vypro II
be associated with chronic inflammation caused (Ethicon, Norderstedt, Germany), was placed as
by mesh include sexual dysfunction and infertility. in group II.
These problems are not well understood. Infertil- After 90 days, vasography was performed, and
ity can be related to the handling of the spermatic blood samples were taken from the venous plexus
cord during inguinal herniorrhaphy. Injury to the of the spermatic cord on both sides. Analysis of s-
vas as well as the spermatic vessels can result in in- testosterone from the spermatic veins was carried
fertility. Ischemic injury to the testicle that eventu- out using competitive radioimmunoassay. Testicles
ally leads to atrophy is reported to occur in about from both sides were weighed. The inguinal areas
0.5% of patients having primary hernia repair and on both sides were dissected en bloc, including
5% with recurrent hernia repairs [7, 8]. Another the spermatic cord, the mesh, and the underlying
potential mechanism for infertility is a foreign abdominal wall. Light microscopy was performed

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Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model
15 2
for a cross-section of specimen obtained from vas deferens in all animals on both sides (⊡ Fig. 2.1).
the middle of the 3-cm long sample stained with There was no significant difference in testicular
hematoxylin–eosin and van Gieson’s stain. Inflam- weight between the groups or between sides. There
mation and fibrosis were graded separately using was no difference in s-testosterone values between
a scale from 0 to 3. The sections of the spermatic the operated and the control sides in group I or II.
cord were captured using a camera, and the images However, in group III, s-testosterone values were
were reduced in pixels to obtain a cross-sectional significantly lower in the operated compared with
area of the vas deferens from both sides. the control side (⊡ Table. 2.1). There was no signifi-
Continuous and nonparametric data were cal- cant difference in vas deferens cross-sectional area
culated as the median (interquartile range) and between the operated and the control side in group
compared using the Mann–Whitney U-test. For I or II, but a difference was seen in group III.
comparing operated and control sides, the Wil-
coxon signed-rank test was used.
Group I (Suture Repair) vs. Groups II
and III (Mesh Repairs)
Results
There was no difference in s-testosterone from
All rats survived the 90-day study period with no the spermatic vein between the operated sides
wound complications. Vasography revealed patent or between the control sides between the groups
(⊡ Table. 2.2). The median grade of inflammation
and fibrosis was significant lower in the suture
repair group compared with the mesh groups. The
inflammation in group I was concentrated around
the sutures; no inflammation was seen in sections
not including sutures. There was no difference
in the cross-sectional area of the vas deferens be-
tween the groups.

Group II (Prolene Mesh) vs. Group III


(Vypro II Mesh)

There was no difference in s-testosterone from the


spermatic vein between the operated and the con-
⊡ Fig. 2.1. Vasography showing patent vas deferens trol side between the groups (⊡ Table. 2.3). There

⊡ Table 2.1. Testicular weight, s-testosterone, and vas deferens diameter: operated vs. control side (medians are presented)

Group I: suture repair Group II: Prolene mesh Group III: Vypro II mesh

Operated Control p Operated Control p Operated Control p


side side side side side side

s-testosterone 127 179 0.176 202 260 0.214 83 127 0.008


(nmol/l)

Vas deferens 157 183 0.753 109 173 0.260 158 187 0.022
cross-sectional
area (pixels)
16 Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model

⊡ Table 2.2. Group I (suture repair) vs. groups II and III (mesh repairs); medians are presented

Group I: suture repair Groups II and III: mesh repairs p

2 Testosterone (nmol/l):
Operated side 127 176 0.849
Control side 179 174 0.935

Inflammation: grade 0–3 1.0 (0–1.3) 2.0 (2.0–2.0) 0.001

Fibrosis: grade 0–3 1.0 (0.8–2.0) 2.0 (1.0–2.5) 0.046

Vas deferens cross-sectional area:


Operated side 157 152 0.400
Control side 183 176 0.809

⊡ Table 2.3. Group II (Prolene mesh) vs. group III (Vypro II mesh); medians are presented

Group II: Prolene mesh Group III: Vypro II mesh p

Testosterone (nmol/l):
Operated side 202 83 0.052
Control side 260 127 0.123

Inflammation: grade 0–3 2.0 (1.5–2.0) 2.0 (2.0–2.0) 0.481

Fibrosis: grade 0–3 2.0 (1.8–2.0) 2.0 (1.0–3.0) 0.696

Vas deferens cross-sectional area:


Operated side 109 173 0.143
Control side 173 187 0.243

was no difference in the grade of inflammation or groups. No statistical difference in inflammation


fibrosis between the groups. In both groups the in- or fibrosis was seen between heavyweight polypro-
flammation was chronic, with histiocytes concen- pylene mesh and the low-weight composite mesh.
trated around the mesh material. Giant cells were, Remaining polyglactin was observed in the low-
however, more prominent in group III (Vypro II), weight composite mesh group after 90 days.
and remaining polyglactin fibres were observed.
There was no difference in the cross-sectional area
of the vas deferens between the groups. Discussion

Polypropylene meshes have been used in hernia


Conclusion surgery for decades, but their use has increased
dramatically the last 10 years. A Cochrane meta-
Vasography revealed a patent vas in all animals. analysis comparing open mesh repairs and con-
The only effects on the cord structures in a rat ventional repairs revealed a decreased risk of re-
model were impaired s-testosterone production currence by 50–75% if mesh were used [2]. The
and a reduced cross-sectional area of the vas after connection between childhood vas injury in in-
the use of a low-weight composite mesh compared guinal hernia repair has been documented [9].
with the control side. This was not demonstrated In adult inguinal hernia surgery, this connection
in the suture repair or heavy polypropylene mesh has not been thoroughly studied. This might be of

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Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model
17 2
clinical importance because almost 30% of the pa- decrease of arterial perfusion, testicular tempera-
tients are operated on for bilateral hernias. There ture, and spermatogenesis. The conclusion was
could be an injury to the duct structures by dis- that a strict indication for implantation of a pros-
section, but theoretically, a foreign body reaction thetic mesh during hernia repair is recommended.
around the mesh could also affect the spermatic In the second study, low-weight and heavyweight
cord structures because the mesh lies in contact polypropylene mesh were compared in rabbits
with the spermatic cord. [15]. Vasography revealed relevant obstructions
Interest in the latter situation has increased located at the mesh margins in 50% of the heavy-
over the last years, and experimental studies weight and 22% in the lightweight mesh groups
have now been performed on dogs, pigs, rabbits, after 6 months. This is in contrast to our results, in
and rats. Uzzo et al. were the first to compare which all vasograms were normal at 3 months.
heavyweight polypropylene mesh to conventional In another study on rats, Kolbe and Lechner
(Shouldice) repair in dogs [11]. In their study, wrapped heavyweight versus low-weight polypro-
all vasograms demonstrated patency, and sperm pylene mesh around the vas [16]. Fertility was
morphology and motility did not differ between tested and was found to be slightly restricted
the groups or between the operated and control 4 weeks after surgery in both groups. Some rats
sides. The patency of the vas was also confirmed in in the heavyweight mesh group revealed sperm
our study. However, Uzzo et al. found morphologic granulomas due to lesions to the spermatic cord.
changes of the testis in three out of six animals in The conclusion was, however, that neither type of
the mesh group. No evidence of testicular impair- hernioplastic implant indicates a negative influ-
ment was seen. They also found a decrease in the ence on male fertility.
cross-sectional diameter of the vas deferens on In a prospective study of 73 patients oper-
the operated side compared with the control side ated on with the plug-and-patch technique, Zieren
in both the suture repair and mesh groups. We et al. measured testicular perfusion and testicu-
reported a cross-sectional reduction only in the lar volume preoperatively and at 3 and 6 months
Vypro II group and not in the Prolene or the suture postoperatively [17]. No differences between the
repair group. contralateral side and operated side were seen at
In a later report by Taneli et al., a polypropyl- follow-up.
ene mesh was compared to a sham-operated group In the present report, the study period of
in rats [12]. It was concluded that mesh implanta- 90 days was chosen for two reasons. First, the man-
tion has no effect on testicular hormonal function ufacturer claims that the polyglactin part of the
and only a limited effect on nitric oxide levels, Vypro II mesh is totally absorbed in 56–70 days,
which was not sufficient to cause testicular apop- thus not participating in the inflammation/fibrosis
tosis that could lead to infertility. reaction at 90 days. Second, the 90-day period has
Maciel et al. reported on a study in rats in previously been used and accepted in studies of
which bilateral vas deferens dissection was per- foreign body reactions [6, 18, 19]. Surprisingly,
formed and a polypropylene mesh placed on one though, we found remaining polyglactin fibres in
side [13]. There were no testicular changes, but the Vypro II specimens after 90 days. This might
changes in the vas that caused functional obstruc- explain the impaired testosterone production and
tion with dilatation and spermatozoid repression smaller cross-sectional area of the vas deferens in
were seen. the Vypro II group compared with the control side.
Two experimental studies from the Aachen There was, however, no difference in inflammation
group concern findings in pigs and rabbits. The or fibrosis between the two mesh groups.
first study consisted of two series, one on pigs and It is well known that polypropylene mesh in-
one on rabbits [14]. Preperitoneal Shouldice and duces a foreign body reaction, with chronic inflam-
Lichtenstein repair were performed, and a poly- mation existing even years after implantation [20],
propylene mesh was used preperitoneally and in a but despite millions of mesh implants, only a few
Lichtenstein repair. The mesh repairs resulted in a reports describe serious adverse effects. Klosterh-
18 Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model

alfen et al. studied the connection between mesh herniorrhaphy in male infertility patients. Fertil Steril
weight and foreign body reaction, and according 58:609–613
10. Sheynkin YR, Hendin BN, Schlegel PN, Goldstein M (1999)
to their studies, the level of inflammatory response Microsurgical repair of iatrogenic injury to the vas defer-
2 depends on the weight and texture of the mesh ens. J Urol 159:139–141
material [20]. The large-pore, lightweight mesh 11. Uzzo RG, Lemack GE, Morrissey KP, Godstein M (1999 )
(Vypro II), which has only 30% polypropylene The effects of mesh bioprosthesis on the spermatic cord
structures: a preliminary report in a canine model. J Urol
compared with standard meshes, has been sug-
161:1344–1349
gested as leading to less foreign body reaction [21]. 12. Taneli F, Aydede H, Vatansever S, Ulman C, Ari Z, Uyanik
Our study did not confirm these findings. BS (2005) The long-term effect of mesh bioprosthesis
It must be stated that animal studies have their in inguinal hernia repair on testicular nitric oxide me-
tabolism and apoptosis in rat testis. Cell Biochem Funct
limitations, and the results cannot be directly trans-
23(3):213–220
ferred to humans. This type of study, though, is not 13. Maciel LC, Glina S, Palma PC, Nascimento LF, Netto NR Jr
possible to do in human patients. The overall effect (2007) Histopathological alterations of the vas deferens in
of meshes in reducing the frequency of recurrence, rat exposed to polypropylene mesh. BJU Int 100(1):187–
and thereby reducing the frequency of a second, 190
14. Peiper C, Junge K, Klinge U, Strehlau E, Ottinger A,
more complicated hernia operation in which the Schumpelick V (2006) Is there a risk of infertility after
spermatic cord could be in danger by dissection, inguinal mesh repair? Experimental studies in the pig and
might well exceed the potential negative effect of the rabbit. Hernia 10(1):7–12
the mesh per se. 15. Junge K, Binnebösel M, Rosch R, Ottinger A, Stumpf M,
Muhlenburch G, Schumpelick V, Klinge U (2008) Influence
of mesh materials on the integrity of the vas deferens fol-
lowing Lichtenstein hernioplasty: an experimental model.
References Hernia 12(6):621–626
16. Kolbe T, Lechner W (2007) Influence of hernioplastic im-
1. The Swedish Hernia Register (Nationellt kvalitetsregister plants on male fertility in rats. J Biomed Master Res B
för bråckkirurgi). http://www.svensktbrackregister.se/.2 Appl Biomater 81(2):435–440
2. The EU Hernia Trialist Collaboration (2002) Open mesh 17. Zieren J, Beyersdorff D, Beier KM, Müller JM (2001) Sexual
function and testicular perfusion after inguinal hernia
versus non-mesh repair of groin hernia meta-analysis of
repair with mesh. Am J Surg 181:204–206
randomized trials based on individual patient data. Her-
18. Baykal A, Onat D, Rasa K, Renda N, Sayek I (1997) Ef-
nia 6: 130–136
fects of polyglycolic acid and polypropylene meshes on
3. Berndsen FH, Petersson U, Arvidsson D, Leijonmarck C-E,
postoperative adhesion formation in mice. World J Surg
Rudberg C, Smedberg S, Montgomery A (2007) Discom-
21:579–583
fort five years after laparoscopic and Shouldice inguinal
19. Bellón JM, Contreras LA, Buján J, Palomares D, Carrera-
hernia repair: a randomised trial with 867 patients. A
San Martin A (1998) Tissue response to polypropylene
report from the SMIL study group. Hernia 11(4):307–313
meshes used in the repair of abdominal wall defects.
4. Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson Biomaterials 19:669–675
U (2006) Risk factors for long-term pain after hernia sur- 20. Klosterhalfen B, Klinge U, Hermanns B, Schumpelick V
gery. Ann Surg 244(2):212–219 (2000) Pathology of traditional surgical nets for hernia
5. Vrijland WW, van der Tol MP, Luijendijk RW, Hop WCJ, repair after long-term implantation in humans. Chirurg
Busschbach JJV, de Lange DCD, van Geldere D, Rottier 71:43–51 [German with English abstract]
AB, Vegt PA, Ijzermans JNM, Jeekel J (2002) Randomized 21. Junge K, Klinge U, Rosch R, Klosterhalfen B, Scumpelick
clinical trial of non-mesh versus mesh repair of primary V (2002) Functional and morphologic properties of a
inguinal hernia. Br J Surg 89:293–297 modified mesh for inguinal hernia repair. World J Surg
6. Klosterhalfen B, Klinge U, Schumpelick V(1998) Functional 26:1472–1480
and morphological evaluation of different polypropyl-
ene-mesh modifications for abdominal wall repair. Bio-
materials 19:2235–2246
7. Wantz GE (1993) Testicular atrophy and chronic residual Discussion
neuraligia as risk of inguinal hernioplasty. Surg Clin North
Am 73:571–581
Kukleta: Do you think that Vypro II is a good rep-
8. Fitzgibbons RJ (2005) Can we be sure polypropylene
mesh causes infertility? Ann Surg 241(4):559–561
resentative for a lightweight mesh? The Vypro II
9. Matsuda T, Horii Y, Yoshida O (1992) Unilateral obstruc- has a bigger inflammatory impact than any other
tion of the vas deferens caused by childhood inguinal lightweight mesh, doesn’t it?

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Chapter 2 · The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model
19 2
Montgomery: Of course. Indeed, this study was
performed in 2003 and published in 2004, and the
available meshes at that time were scientifically the
most interesting ones.
Köckerling: In our various studies with partially
resorbable meshes, we always found after the time
given by the company some remaining resorb-
able material in the animals with a high grade
of inflammatory reaction around it. We should
learn from this to take longer observation periods
because the absorption process obviously takes
longer than given by the company.
Montgomery: That’s why we chose a 90-day inter-
val in our study, but it wasn’t enough.
Conze: I just want to make a remark on the animal
models used in this context. The diameter of the
spermatic cord of small animals differs from hu-
man ones, and therefore, the ratio of the diameter
of mesh fibers and spermatic cord differs. So the
effect of the fibrotic reaction on a very tiny rat vas
is much stronger than it might be on a human vas.
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3

Damage to the Spermatic Cord


by the Lichtenstein Procedure
in a Pig Model–Preliminary Results
K. Junge, M. Binnebösel, C. Kauffmann, R. Rosch, J. Otto, D. Kämmer, F. Schoth,
G. Mühlenbruch, U. Klinge, V. Schumpelick
22 Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results

Introduction Material and Methods

An estimated 75–80% of inguinal hernia opera- Mesh Materials


tions involve placing a mesh prosthesis, either
laparoscopically or using an open technique, to Two different mesh materials were investigated:
patch the defect in the floor of the inguinal a large porous and elastic mesh made of PVDF
3 canal. Foreign body reactions, with fibroblastic monofilaments and Marlex, a small-pore, stiff
ingrowth and chronic inflammation, are believed mesh made of polypropylene (PP) monofilaments
to reinforce the abdominal wall and decrease (⊡ Fig. 3.1).
the risk of recurrence. It has been proven that
this foreign body reaction is proportionate to
the weight, structure, and polymer of the mesh Animals
and that commonly used meshes contain too
much material, producing an exaggerated for- Six male uncastrated male pigs were housed un-
eign body reaction/tissue response and leading der conditions of constant light and temperature
to clinical complications [1–3]. To minimize the and received a complete diet of feed and water ad
foreign body reaction and clinical complications, libitum throughout the entire study, which was
new types of mesh materials have been intro- performed according to the National Institutes of
duced that have a decreased amount of material
and larger pores, resulting in a nearby physi-
ologic tissue ingrowth [2, 4, 5]. Further improve-
ment of biocompatibility has been achieved using
polyvinylidene fluoride (PVDF) as the polymer
[3]. PVDF is a polymer with improved textile
and biological properties [6]. Compared with
polyester, PVDF is more resistant to hydroly-
sis and degradation. Furthermore, ageing does
not increase the stiffness that is evidently seen
in polypropylene. Although it has been used
in vascular surgery for some years, there have
been limited types of surgical meshes until now.
a
Whereas these so-called lightweight, large-pore,
and elastic mesh materials are known to show
a favourable outcome considering postoperative
pain [7–10] compared with conventional heavy-
weight, small-pore, and stiff mesh materials, just
a few experimental studies have focused on the
influence of different mesh materials on the in-
tegrity of the vas deferens. With the widespread
acceptance and ease of placement, mesh repair
is being increasingly offered to young patients
whose fertility status may well be an issue in
the future.
To further elucidate the impact of different
b
mesh materials following Lichtenstein hernia re-
pair, an animal study in the pig was conducted to ⊡ Fig. 3.1. a A large-pore, elastic mesh made of polyvinylide-
investigate the long-term effect on integrity of the ne fluoride monofilaments. b A small-pore, stiff mesh made of
vas deferens and testicular function. polypropylene monofilaments

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Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure
23 3
Health guidelines for the use of laboratory ani- months after mesh implantation, all animals (n=6)
mals. All animals received bilateral Lichtenstein underwent thermographic investigation of the in-
hernia repair (n=12). guinal region and the testes. Thermographic mea-
surements were performed as a parameter of local
perfusion using a VarioCAM basic camera (In-
Surgical Procedure fraTec, Dresden, Germany). Following measure-
ment of testicular size by ultrasound, the animals
Operations were carried out under general an- were sacrificed for morphologic observations. The
aesthesia. Following premedication using 4 mg/ abdomen was opened for complete exploration.
kg azaperone, 44 μg/kg atropine, and 15 mg/kg The intraabdominal part of the vas deferens was
ketamine intramuscularly, an intravenous catheter dissected 2 cm before entering the inguinal canal
was placed into an ear vein. Anaesthesia was in- at both sides, and 10 ml of x-ray solution was
duced by injection of 10–15 mg pentobarbital. An- injected for vasography (13.3 g gelatin, 16.6 g
aesthesia was continued by isoflurane/oxygen as Bleimennige =Pb2PbO4, 100 ml water). Following
well as continuous infusion of fentanyl (45–90 μg/ ligation of the vas deferens, the whole inguinal
kg/h). Following anaesthesia, the skin was shaved canal–including the mesh sample as well as the
and disinfected with a povidone–iodine solution. testis–was resected and fixed in 10% formaldehyde
An inguinal incision was performed and the (⊡ Fig. 3.2).
external oblique fascia dissected. Following explo-
ration of the inguinal canal, a Lichtenstein proce-
dure was carried out using a 7×10-cm slitted mesh Assessment of Integrity of the
sample (PVDF mesh on one side, PP mesh on the Vas Deferens
contralateral side). Mesh samples were fixed at the
inguinal ligament and the mesh slit was closed us- Integrity of the vas deferens was assessed semi-
ing 4/0 Prolene sutures. Afterwards, the external quantitatively using x-ray vasography. Obstruc-
oblique fascia and skin were closed. tions of the vas deferens were classified as minor
No antibiotic treatment was given before or (0–25% reduction in lumen diameter), medium
during the experiments. Throughout the whole (25–75% reduction), or major (>75% reduction)
observation period, all animals were objectively and were examined at the margins of the mesh
controlled and underwent daily clinical investiga- samples as well as within the mesh area.
tion to assess local and systemic complications. Six

Histological Analysis

Tissue specimens were embedded in paraffin. His-


tological investigation was performed on 3-μm
sections after haematoxylin and eosin staining. All
sections were processed at the same time to reduce
internal staining variations. Spermatogenesis as
the main testicular function was estimated histo-
logically using the Johnsen score (⊡ Table 3.1) [11].
Immunohistochemistry was done according to the
manufacturer’s instructions. For detection of pro-
liferating cells (Ki67), we used mouse monoclonal
antibody MIB-1, 1:10, from Dako (Glostrup, Den-
mark) and rabbit antimouse antibody 1:300 from
⊡ Fig. 3.2. Explanted inguinal area including testis with injec- Dako (Glostrup, Denmark) as secondary antibody.
ted x-ray solution TUNEL histochemistry for the detection of apop-
24 Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results

Thermography
⊡ Table 3.1. Johnsen score [11]

10 Complete spermatogenesis with many sperma- Investigating the mean inguinal temperature at the
tozoa initial incision, no differences were found compar-
9 Many spermatozoa present but germinal epi- ing the PVDF mesh (34.9±0.9°C) with the PP mesh
thelium (34.7±0.9°C). Furthermore, no difference was
3 found in testis temperature (PVDF 29.0±1.1°C; PP
8 Only few spermatozoa (<5–10) present in section
29.1±1.1°C; see ⊡ Figs. 3.3 and 3.4).
7 No spermatozoa but many spermatids present

6 No spermatozoa and only few spermatids


(<5–10) present
Integrity of the Vas Deferens
5 No spermatozoa, no spermatids but several or
Following explantation, x-ray vasography showed
many spermatocytes present
analysable results for all mesh implantations. Over-
4 Only few spermatocytes (<5) and no spermatids all, relevant obstructions (>75% of lumen diameter;
or spermatozoa present
⊡ Fig. 3.5) were located only at the mesh margins.
3 Spermatogonia are the only germ cells present Whereas four PVDF explants showed no or minor
obstructions, one out of six PVDF explants had an
2 No germ cells but Sertoli cells are present
obstruction 25–75% of the lumen diameter. The PP
1 No cells in tubular section mesh group explants were found to have signifi-
cant obstructions of more than 75% of the lumen
diameter in two specimens, as well as obstructions
of 25–75% of the lumen diameter in another two.
totic cells was performed by an in situ apopto- Histologically, no direct infiltration of the mesh fi-
sis detection kit (Apoptag, Oncor, cat. no. S7100, bres into the vas deferens was found. Obstructions
Germany). Sections were examined by standard were more or less due to compression of the wall
light microscopy (Olympus BX51, Hamburg, Ger- of the vas deferens, inducing an inflammatory and
many). For each sample, five regions within the fibroblastic reaction in the wall of the vas.
interface (×400; area 100×100 μm) were captured
by a digital camera (Olympus C-3030, Hamburg,
Germany). The expression of immunohistochemi- Histological Analysis
cal parameters was classified by two independent,
blinded observers. The extent of staining was grad- Testicular function was estimated histologically.
uated as a percentage of positive-stained cells in Each testicular sample of 10 seminiferous tubules
the specimen (0–100%). was classified according to the Johnson score. Fol-
lowing PP mesh implantation, a mean Johnson
score of 8.5±0.1 was estimated, which was not sig-
Results nificantly different from that for the PVDF mesh
samples (8.5±0.3, ⊡ Fig. 3.6).
Macroscopic Observation Analysing three out of six mesh explants, each
group microscopic investigation of the mesh–host-
The surgical procedure was well tolerated by all tissue interface showed typical formation of for-
animals, and the postoperative period was un- eign body granulomas. Investigating the percent-
eventful. None of the animals developed signs of age of apoptotic (TUNEL) and proliferating (Ki67)
ischaemic orchitis or testicular atrophy. No dif- cells, no significant differences were found be-
ferences were seen in testicular volume between tween the PP (TUNEL 12.7±8.0%; Ki67 7.4±1.8%)
the PP (18.9±2.2 cm3) and the PVDF mesh groups and the PVDF mesh samples (TUNEL 3.4±3.3%;
(18.1±4.0 cm3). Ki67 6.0±2.5%; ⊡ Fig. 3.7).

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Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure
25 3

⊡ Fig. 3.3. Example of temperature measurement using ther- ⊡ Fig. 3.5. Vasography following mesh implantation; note ob-
mography camera struction of the vas deferens at the margin following polypro-
pylene mesh implantation

⊡ Fig. 3.4. Temperatures


(mean ± standard deviation)
measured using the thermogra-
phy system (PP polypropylene,
PVDF polyvinylidene fluoride)

⊡ Fig. 3.6. Johnsen score, show-


ing mean ± standard deviation
(PP polypropylene, PVDF polyvi-
nylidene fluoride)
26 Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results

⊡ Fig. 3.7. Percentage


3 (mean ± standard deviation) of
(a) proliferating and (b) apo-
ptotic cells at the interface of
mesh and the host tissue (PVDF
polyvinylidene fluoride, PP po-
lypropylene)

Discussion phologic changes of the testis were found in three


of six animals in the mesh group. Goldenberg et
Obstructive azoospermia is a rare but serious al. investigated 18 dogs with a follow-up of 60 days
complication following inguinal hernia repair. Al- and found a chronic inflammatory reaction in
though an incidence of iatrogenic perioperative 100% on the mesh side, a reduction in spermato-
injury to the vas deferens during inguinal hernia genesis, and a reduction in lumen diameter of the
repair of 0.3% in adults and 0.8–2.0% in child- vas deferens on the mesh side [15].
hood has been described [12], little is known about However, studies comparing the effect of dif-
the long-term effects of different mesh prosthe- ferent mesh prostheses are rather limited. Peiper et
ses on the integrity of the vas deferens. Because al. investigated spermatic cord perfusion and sper-
almost 30% of the patients are operated on for matogenesis in rabbits, comparing Lichtenstein
bilateral hernias, and because mesh repair is be- hernia repair using UltraPro (a lightweight, large-
ing increasingly offered to young patients whose pore, and elastic mesh) and Marlex (a heavyweight,
fertility status may well be an issue in the future, small-pore, and stiff mesh of polypropylene) with
this item is of major clinical importance. Aside the Shouldice repair [16]. They found a more ob-
from case reports, just one larger clinical series vious decrease in spermatic cord perfusion after
has been reported. Shin et al. investigated 14 cases Marlex mesh repair than after Shouldice repair. In
of azoospermia secondary to inguinal vasal ob- contrast, in our study the analysed temperature (as
struction related to previous mesh herniorrhaphy a parameter of perfusion) showed no differences
[13]. Following open or laparoscopic hernia mesh between the mesh samples in the inguinal region
repair, they reported on nine patients with bilateral or in the testis. In evaluating spermatogenesis,
obstruction as well as five patients with unilateral Peiper’s group noted a decrease in Johnsen score in
obstruction. Surgical exploration revealed a dense the seminiferous tubules after Lichtenstein repair
fibroblastic response encompassing the polypro- independent of the kind of mesh. In our study, a
pylene mesh, with either a trapped or obliterated mean Johnsen score of 8.5±0.1 was estimated fol-
vas in all patients. lowing PP mesh implantation, which was not sig-
The first experimental study investigating this nificantly different from the group of PVDF mesh
matter was performed by Uzzo et al., comparing samples (8.5±0.3). No control group had been
six dogs operated with a polypropylene mesh to six analysed until now.
dogs operated with conventional (Shouldice) repair Berndsen et al. compared a low-weight com-
[14]. They found a decrease in the cross-sectional posite mesh (Vypro II) and a heavyweight mesh
diameter of the vas deferens on the operated side (Prolene) used for Lichtenstein repair in rats [17].
compared with the control side in both the suture Ninety days after implantation, a median cross-
repair and the mesh groups. Furthermore, mor- sectional area of the vas deferens was 109 pixels

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Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure
27 3
for the Prolene and 158 pixels for the Vypro II side, 4. Junge K, Klinge U, Prescher A, Giboni P, Niewiera M,
with no significant difference. Schumpelick V. Elasticity of the anterior abdominal wall
and impact for reparation of incisional hernias using
In our study, obstructions were analysed semi-
mesh implants. Hernia 2001; 5(3):113–118
quantitatively using vasography. Investigations re- 5. Klinge U, Klosterhalfen B, Conze J, Limberg W, Obolenski
vealed obstructions that were mainly located at the B, Ottinger AP et al. Modified mesh for hernia repair that
mesh margins. The stiff PP mesh group showed is adapted to the physiology of the abdominal wall. Eur J
an overall higher amount and degree of stenosis Surg 1998; 164(12):951–960
6. Urban E, King MW, Guidoin R, Laroche G, Marois Y, Martin
compared with the smooth PVDF mesh. Next to
L et al. Why make monofilament sutures out of polyvi-
a significantly reduced inflammatory foreign body nylidene fluoride? ASAIO J 1994; 40(2):145–156
reaction of the PVDF (TUNEL 3.4±3.3%; Ki67 7. Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund
6.0±2.5%) compared with the PP mesh (TUNEL H, Heikkinen TJ. Three-year results of a randomized clini-
12.7±8.0%; Ki67 7.4±1.8%), the lower number of cal trial of lightweight or standard polypropylene mesh in
obstructions was probably due to the elastic textile Lichtenstein repair of primary inguinal hernia. Br J Surg
2006; 93(9):1056–1059
properties of the PVDF mesh. In contrast to the 8. O’Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lam-
study by Shin et al., we could find no direct in- mers B, Horeyseck G. Randomized clinical trial assess-
filtration of the mesh fibres into the vas deferens. ing impact of a lightweight or heavyweight mesh on
Obstructions were mainly due to compression of chronic pain after inguinal hernia repair. Br J Surg 2005;
the wall at the mesh side, with an induced inflam- 92(2):166–170
9. Horstmann R, Hellwig M, Classen C, Rottgermann S,
matory and fibrotic reaction in the wall of the vas
Palmes D. Impact of polypropylene amount on functional
deferens. outcome and quality of life after inguinal hernia repair
To summarize, great effort has been put into by the TAPP procedure using pure, mixed, and titanium-
the challenge of creating a mesh material that coated meshes. World J Surg 2006; 30(9):1742–1749
optimises patients’ outcomes. The introduction 10. Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud
H, Bleichrodt R. Chronic pain after mesh repair of in-
of improved mesh materials has led to superior
guinal hernia: a systematic review. Am J Surg 2007;
outcomes with regard to postoperative pain and 194(3):394–400
foreign body sensation. However, the influence of 11. Johnsen SG. Testicular biopsy score count–a method for
different mesh materials on spermatic cord struc- registration of spermatogenesis in human testes: normal
tures has not been studied thoroughly. For the first values and results in 335 hypogonadal males. Hormones
1970; 1:2–25
time, the construction of a large-pore and elastic
12. Pollak R, Nyhus LM. Complications of groin hernia repair.
monofilamentous PVDF mesh showed a benefi- Surg Clin North Am 1983; 63(6):1363–1371
cial effect on the integrity of the vas deferens in 13. Shin D, Lipshultz LI, Goldstein M, Barme GA, Fuchs EF,
an experimental setting. However, no differences Nagler HM et al. Herniorrhaphy with polypropylene mesh
were observed in testicular function (temperature, causing inguinal vasal obstruction: a preventable cause of
volume, spermatogenesis). obstructive azoospermia. Ann Surg 2005; 241(4):553–558
14. Uzzo RG, Lemack GE, Morrissey KP, Goldstein M. The ef-
fects of mesh bioprosthesis on the spermatic cord struc-
tures: a preliminary report in a canine model. J Urol 1999;
References 161(4):1344–1349
15. Goldenberg A, Matone J, Marcondes W, Herbella FA, Farah
1. Klosterhalfen B, Klinge U, Schumpelick V. Functional and JF. Comparative study of inflammatory response and
morphological evaluation of different polypropylene- adhesions formation after fixation of different meshes
mesh modifications for abdominal wall repair. Biomateri- for inguinal hernia repair in rabbits. Acta Cir Bras 2005;
als 1998; 19(24):2235–2246 20(5):347–352
2. Junge K, Klinge U, Rosch R, Klosterhalfen B, Schumpelick 16. Peiper C, Junge K, Klinge U, Strehlau E, Krones C, Ottinger
V. Functional and morphologic properties of a modi- A et al. The influence of inguinal mesh repair on the sper-
fied mesh for inguinal hernia repair. World J Surg 2002; matic cord: a pilot study in the rabbit. J Invest Surg 2005;
26(12):1472–1480 18(5):273–278
3. Klinge U, Klosterhalfen B, Ottinger AP, Junge K, 17. Berndsen FH, Bjursten LM, Simanaitis M, Montgomery
Schumpelick V. PVDF as a new polymer for the con- A. Does mesh implantation affect the spermatic cord
struction of surgical meshes. Biomaterials 2002; 23(16): structures after inguinal hernia surgery? An experimental
3487–3493 study in rats. Eur Surg Res 2004; 36(5):318–322
28 Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results

Discussion

Kehlet: If we see these very good pictures and


compare them to other studies concerning this
problem, we should have an agreement using only
one model to investigate this problem.
3 Smeds: My question is, you have animals with
damage and without damage in both groups with
both types of meshes. Did you make a deeper anal-
ysis of this damage, and what is the reason for it?
Junge: At this point we didn’t perform deeper
analysis. We have to look on the histological sec-
tions to find out what is the detailed cause for this
damage.

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4

Influence of Prosthetic Implants


on Male Fertility in Rabbits and Rats
C. Peiper, K. Junge, A. Oettinger, M. Binnebösel
30 Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats

Introduction cleaned and shaved, the skin was disinfected using


Braunoderm, and the operating field was covered
Modern concepts for treating inguinal hernias al- by sterile cloths. All operations were carried out
ways include prosthetic mesh repairs. Some sur- under aseptic and sterile surgical conditions.
geons use the mesh repair exclusively [1]. Reported
results are promising concerning recurrence rates
[2] and return to physical activity [3]. On the other Rabbit Study 1
hand, there is a certain risk of complications due
4 to the mesh that are difficult to detect. Alterations Eight chinchilla rabbits underwent unilateral in-
of fertility, if observable, may be recorded only in guinal hernia repair following the Lichtenstein ap-
very large series. We know that prosthetic meshes proach [7]. All rabbits received implantation of a
implanted into the abdominal wall cause chronic Marlex mesh (Bard, Cranston, RI, USA). This is
inflammatory changes of the surrounding tissue [4]. a small-pore, heavyweight polypropylene mesh.
Because of the close contact between mesh and the Shouldice repair was carried out on the contral-
structures of the spermatic cord after inguinal mesh ateral side [8]. Another three rabbits served as
repair, these changes may also alter the reproductive controls.
structures in male patients. Case reports have been Under aseptic conditions, the inguinal canal
published about spermatic granuloma [5] and sper- was opened by dividing the external oblique fascia,
matoceles [6] after Lichtenstein hernia repair. Espe- and the spermatic cord was secured by a loop. We
cially after mesh implantation in younger patients, preserved the cremasteric muscle. The Lichten-
these findings may be of great importance. stein repair was performed with fixation of the
In a rabbit experimental model, we investigated mesh at the inguinal ligament and the internal
the interaction between mesh and the adjacent oblique muscle using interrupted Miralene sutures
spermatic cord concerning the extent of inflamma- (Miralene 0 HRT 26, Braun-Dexon). The lateral
tory changes and their relationship to the material end of the mesh was slit into two tails and closed
used, the integrity of the deferent duct, and the against the lateral aspect of the internal inguinal
influence on the testicular function. ring using Miralene sutures.
Afterwards, the contralateral inguinal region
was prepared. Here, a simple Shouldice repair was
Materials and Methods performed following the same extensive prepara-
tion using running Miralene sutures. Thus, every
These experiments were officially approved by animal served as its own control.
the district president of North Rhine-Westphalia, Animals were kept in standard rabbit cages of
Germany (AZ 50.203.2-AC 18, 3/01). All animals 60×60×60 cm at a temperature range of 20–22°C
received humane care in accordance with the re- and a light circle of 12 h. They were fed dry pellets
quirements of the German Animal Protection Act. (Ssniff, 40 g/animal/day).
All operations were carried out under general an- Three months later, we evaluated testicular
esthesia. An intravenous catheter was placed into changes. The testicular volume was measured by
an ear vein. After premedication using subcuta- ultrasound and calculated using the formula of a
neous buprenorphine 0.3 ml/kg, anesthesia was rotating ellipsoid [9]. Testicular temperature was
induced by injection of Domitor 0.3 ml/kg and evaluated using a digital thermometer (Voltcraft
ketamine 10% 0.2 ml/kg. Anesthesia was contin- 300K) with a needle sensor.
ued by repeated injections of these medications. Arterial perfusion of the spermatic cord and
Additionally, the animals were ventilated by isoflu- testicles was investigated using the IC-VIEW sys-
rane/air after endotracheal intubation. All animals tem (Pulsion Medical Systems, Munich, Germany).
received pulse oximetry and electrocardiographic Skin and subcutaneous tissue were removed from
monitoring during the operation. The animals the lower abdomen, and the scrotal skin was re-
were fixed in the supine position. After the fur was moved completely (⊡ Fig. 4.1a). A 0.5 mg/kg bolus

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Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats
31 4

⊡ Table 4.1. Johnsen score for qualitative evaluation


of spermatogenesis [10]

1 No cells in tubular section

2 No germ cells, but Sertoli cells present

3 Spermatogonia are the only germ cells present

4 Only a few spermatocytes (<5) and no sperma-


tids or spermatozoa present

5 No spermatozoa and no spermatids, but several


a
or many spermatocytes present

6 No spermatozoa and only a few spermatids


(<5–10) present

7 No spermatozoa, but many spermatids present

8 Only a few spermatozoa (<5–10) present in


section

9 Many spermatozoa present, but germinal epi-


thelium disorganized, with marked sloughing
or obliteration of lumen

10 Complete spermatogenesis with many sperma-


b tozoa (late spermatids)

(⊡ Fig. 4.1b) and was transferred to a computer for


further quantification of perfusion-related fluores-
cence intensity (IC-CALC; ⊡ Fig. 4.1c). We calcu-
lated the difference between the intensity before
and the maximum intensity after injection as an
index for maximum perfusion. This parameter was
recorded at the spermatic cord and at the testicles.
Spermatogenesis as the main testicular func-
c tion was estimated histologically using the Johnsen
score [10] (⊡ Table. 4.1).
⊡ Fig. 4.1. Testicles and spermatic cord of a rabbit after prepa- The spermatic cords were excised, includ-
ration and before evaluation of arterial perfusion (a), during ing the deep inguinal ring. Representative cross-
flush of indocyanine green and under excitation of near-
sections were obtained at this area and analyzed
infrared light (b), and after transfer of the fluorescence inten-
sity into colors (c) histologically using hematoxylin and eosin stains,
focusing on the inflammatory response to the
prosthetic mesh.

of indocyanine green (ICG) was injected intra-


venously into the ear vein. Excitation light was Rabbit Study 2
provided by an IC-VIEW system camera-mounted
near a near-infrared (NIR) light source (780 nm). To differentiate among the results of different mesh
ICG-derived fluorescence was detected by a materials, we conducted an additional animal
digital camera using the super-night-shot mode study using the same conditions and techniques
32 Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats

mentioned above. We included 20 male chinchilla Results


rabbits. All animals underwent bilateral Lichten-
stein repair with a Prolene mesh (Ethicon, Norder- Rabbit Study 1
stedt, Germany) on one side and Ultrapro mesh
(Ethicon, Norderstedt, Germany) on the other In the postoperative period, we observed an in-
side. Analysis followed after 6 months. After ex- creased testicular volume (⊡ Fig. 4.3), with no dif-
plantation of the inguinal region of the abdominal ference between the kinds of repair (p=0.53),
wall, we analyzed the patency of the vas deferens and a decreased testicular temperature com-
4 by injecting x-ray solution into the vas (⊡ Fig. 4.2). pared with the controls (⊡ Fig. 4.4). Here, too,
Additionally, we used light microscopy to measure the differences among the operations were small
the size of the foreign body granulomas induced (p=0.246).
by the meshes. A cause for these findings may be the re-
Global statistical analysis was carried out using duced arterial perfusion that exists after any re-
the Kruskal–Wallis test. For statistics among the pair (p<0.05). In comparison to the controls,
groups, we used the Mann–Whitney test. this decrease in spermatic cord perfusion was
more obvious after Lichtenstein repair (p=0.03;
⊡ Fig. 4.5) than after the Shouldice operation. The
Injection of x-ray solution testicular perfusion was also significantly reduced
after Lichtenstein mesh implantation (p<0.05;
ligation of ductus ⊡ Fig. 4.6).
Evaluation of spermatogenesis revealed a de-
crease in the Johnsen 10 score in seminiferous
tubules after Lichtenstein repair. Following Shoul-
dice repair, the testicles showed regular spermato-
ductus
genesis (p=0.20; ⊡ Fig. 4.7).
mesh
During histological evaluation of the surround-
ing tissue, we observed a characteristic foreign
body reaction to the mesh (⊡ Fig. 4.8), which we
did not find after the Shouldice repairs. Destruc-
tion of the vas deferens wall or venous thrombosis
was not detected. The duct was patent in all speci-
testicle
mens. Obviously, the preserved cremasteric muscle
⊡ Fig. 4.2. Vasography after resection of the inguinal region of protected the structures of the spermatic cord in
the abdominal wall this model.

⊡ Fig. 4.3. Testicular volume (ml)


3 months after groin mesh im-
plantation in the rabbit

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Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats
33 4

⊡ Fig. 4.4. Testicular temperature


(°C) 3 months after groin mesh im-
plantation in the rabbit

⊡ Fig. 4.5. Spermatic cord perfusion


(a.u.) 3 months after groin mesh im-
plantation in the rabbit, analyzed by
the IC-VIEW system

⊡ Fig. 4.6. Testicular perfusion (a.u.)


3 months after groin mesh implan-
tation in the rabbit, analyzed by the
IC-VIEW system

⊡ Fig. 4.7. Percentage of mature


spermatogenesis (Johnsen 10)
3 months after groin operation in
the rabbit
34 Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats

Rabbit Study 2

During vasography, several specimens showed sig-


nificant reduction of the vas deferens diameter
(⊡ Fig. 4.9). Most of the obstructions were observed
at the margin of the mesh. Severe obstruction
(>75%) was found in 50% of the Prolene margins
and 22.2% of the Ultrapro mesh edges. Within the
4 mesh area, we saw no severe obstruction. Mod-
erate obstruction (25–75%) also occurred more
often in the Prolene group (⊡ Table. 4.2).
Analysis of spermatogenesis revealed the same
postoperative decrease in spermatozoa counted as
⊡ Fig. 4.8. Inflammatory changes of the spermatic cord 3 Johnsen 10 after mesh implantation as was observed
months after Marlex mesh implantation in the rabbit (mesh
in the first study. Because of the different mesh
fiber right upper, deferent duct left lower; hematoxylin and
eosin, 100×)
material, the difference in the controls did not reach

⊡ Fig. 4.9. Vasography 6 months


after inguinal Prolene mesh im-
plantation in the rabbit

⊡ Table 4.2. Obstruction of the vas deferens 6 months after mesh implantation in the rat

Obstruction at mesh margin Obstruction within mesh area

0/+ ++ +++ 0/+ ++ +++


(<25%) (25–75%) (>75%) (<25%) (25–75%) (>75%)

Prolene 43.75% (7/16) 6.25% 50% (8/16) 75% (12/16) 25% (4/16) 0%
(1/16) (0/16)

Ultrapro 77.8% (14/18) 0% 22.2% (4/18) 83.3% (15/18) 16.7% (3/18) 0% (0/18)
(0/18)

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Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats
35 4

⊡ Fig. 4.10. Percentage of mature


spermatogenesis (Johnsen 10)
6 months after groin mesh im-
plantation in the rabbit

⊡ Fig. 4.11. Size of foreign body


granuloma 6 months after groin
mesh implantation in the rabbit

statistical difference. The decrease was also not dif- levels in the spermatic veins compared with the
ferent in the different material types (⊡ Fig. 4.10). controls. Furthermore, the cross-sectional area of
Histological analysis revealed larger foreign the vas deferens was also reduced after mesh im-
body granulomas after Prolene mesh implantation plantation [11].
than after Ultrapro mesh implantation (p<0.05, Taneli and colleagues published a study in 2005
⊡ Fig. 4.11). that included 40 animals. Analysis was conducted
6 months after groin mesh implantation. An induc-
ible nitric oxide synthase expression was detected
Results in Rat Experiments in the ipsilateral testis after mesh implantation.
Apoptotic cells were not detected. The authors
Berndsen and colleagues conducted groin mesh concluded that long-term polypropylene mesh im-
implantation in 30 rats and analyzed the animals plantation has no effect on testicular hormonal
after 90 days. They found reduced s-testosterone function and only a limited effect on nitric oxide
36 Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats

levels and that this effect is not sufficient to cause difference did not reach statistical significance.
testis apoptosis that could lead to infertility [12]. No differences between the mesh materials were
Kolbe and Lechner also investigated the effect observed. Further experiments with larger groups
of hernioplastic implants on male rat infertility, seem to be necessary after this study.
comparing the results after Prolene mesh implan- At first glance, the observed changes might be
tation to the effects after Vypro II and with control of no major clinical relevance in unilateral repair
animals. They observed some sperm granulomas and could be important only in bilateral repairs.
in the Prolene group but saw no negative influence However, the literature contains several reports of
4 on male fertility in juvenile or adult rats [13]. serum antisperm antibody production after unilat-
The effect of the mesh on the vas deferens of eral ischemic injury to the testis or the spermatic
the rat was investigated by Maciel and colleagues, cord [15]. This has also been reported in patients
with results published in 2007. They observed a after inguinal hernia repair [16, 17]. These antibod-
foreign body reaction of the spermatic cord, in- ies may lead to male infertility even after unilateral
cluding histological changes of the vas deferens, changes and are therefore of major relevance. Fur-
functional obstruction and dilatation of the duct, ther research on this topic is mandatory.
spermatozoid repression, and a loss of mucosal The influence on humoral conditions will also
folding proximal to the mesh. In epididymides and be a topic of further investigations. Akbulut et
testicles, no changes were found [14]. al. observed decreased levels of testosterone after
laparoscopic hernia repair (totally extraperitoneal
repair) [18]. This finding is supported by animal
Discussion experiments by Uzzo and colleagues in a canine
model [19] and by Berndsen et al. in the rat [11].
The effect on the surrounding soft tissue of long- One explanation for the morphological and
term implantation of a mesh bioprosthesis for her- functional changes observed in our study may be
nia repair is under current discussion and inves- adhesion formation between the mesh and the
tigation. A persisting, inflammatory, proliferative structures of the spermatic cord as a result of the
foreign body reaction with increased cell turnover foreign body reaction. These adhesions were also
in the recipient tissues even years after implanta- described by Fitzgibbons et al. [20] in the pig. They
tion has been described [4]. These major inflam- found adhesions between the mesh and structures
matory responses to mesh implantation have been of the spermatic cord even after intraperitoneal
mostly reported after incisional hernia repair, but placement of the mesh.
also after bioprosthesis implantation in inguinal LeBlanc et al. [21] placed a heavyweight poly-
hernia operations. propylene mesh into the preperitoneal space and
Therefore, we investigated the effect of this also observed severe adhesions to the spermatic
inflammatory reaction on the spermatic cord and cord 30 days after implantation. Ninety days after
testicular function in a rabbit model. We observed operation, adhesions to the spermatic vessels and
only minor inflammatory changes. Perhaps this re- the spermatic cord as well as venous congestion
duced reaction was due to the short postoperative of the testis were described. This may also serve
period. Despite this small morphological response, as an explanation for the observed deferent duct
we found a significant influence on testicular per- obstruction in our experiments.
fusion and function. Testicular temperature was One additional aspect is the protection of the
reduced in the postoperative phase after any repair, structures of the spermatic cord by the cremas-
while testicular perfusion was lowest following teric muscle. These structures were protected from
the Lichtenstein operation. Spermatogenesis also inflammation if the cremasteric muscle was pre-
showed a reaction to the implanted mesh. The served, as we did in this rabbit model. Perhaps this
amount of regular spermatogenesis classified as strategy might be advisable instead of complete
Johnsen 10 was reduced in comparison to that resection of the cremasteric muscle during mesh
after Shouldice repair and in the controls, but this implantation.

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Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats
37 4
There are also reports about reactions to ingui- propylene mesh into the inguinal region without a
nal prosthetic mesh in men. The most important good indication.
publication on this topic is by Shin and colleagues,
published in 2005. They reported on 14 young
male patients undergoing open or laparoscopic Conclusion
groin mesh implantation. Nine of them presented
bilateral vas deferens obstruction, and the other Until more data are available, we see a limited
five suffered from unilateral obstruction with con- indication for mesh implantation during inguinal
tralateral testicular atrophy. The authors suggested hernia repair in young patients, as an effect on
that men–especially those of young reproductive testicular function and spermatogenesis is pos-
age or with a solitary testicle–should be care- sible. Preserving the cremasteric muscle fibers may
fully advised of the potential for obstruction and protect the spermatic cord.
compromise to future fertility before undergoing
polypropylene mesh herniorrhaphy [22].
Valenti et al. reported a case of fibrotic vas Acknowledgements
deferens obstruction due to direct contact of an
implanted plug with the vas [23]. Parts of these experiments were supported by
Wingenbach et al. reported long-lasting pain the Deutsche Forschungsgemeinschaft (AZ KON
during copulation in 3.9% of all cases after laparo- 709/2002, PE 718/4-1).
scopic hernia repair [24].
Langenbach et al. found painful ejaculation
in 10%, 12 weeks after laparoscopic repair [25], References
which correlated with the kind of mesh.
Hetzer et al. reported spermatoceles requiring 1. Bittner R, Schmedt CG, Schwarz J, Kraft K, Leibl BJ. Lap-
aroscopic transperitoneal procedure for routine repair of
operation after Lichtenstein repairs in 0.8% [6].
groin hernia. Br J Surg 2002; 89:1062–1066
Silich and McSherry reported a case of a sper- 2. Wara P, Bay-Nielsen M, Juul P, Bendix J, Kehlet H. Prospec-
matic granuloma requiring operation 2 years after tive nationwide analysis of laparoscopic versus Lichtenstein
mesh repair of an inguinal hernia [5]. repair of inguinal hernia. Br J Surg 2005; 92:1277–1281
Aasvang et al. conducted a questionnaire-based 3. Fenoglio ME, Bermas HR, Haun WE, Moore JT. Inguinal
hernia repair: results using an open preperitoneal ap-
analysis of 1,015 patients 1 year after mesh-based
proach. Hernia 2005; 9:160–161
inguinal hernia repair. They found relevant pain 4. Klosterhalfen B, Klinge U, Hermanns B, Schumpelick V.
during physical activity in 18.4% and pain during Pathology of traditional surgical nets for hernia repair
sexual activity in 22.1%. Genital or ejaculatory after long-term implantation in humans. Chirurg 2000;
pain occurred in 12.3%, and 2.8% of the patients 71:43–51
5. Silich RC, McSherry CK. Spermatic granuloma. An uncom-
complained about moderate or severe impairment
mon complication of the tension-free repair. Surg Endosc
of their sexual activity [26]. Out of this popula- 1996; 10:537–539
tion, the authors intensified analysis in 10 selected 6. Hetzer FH, Hotz T, Steinke W, Schlumpf R, Decurtins M,
patients with postherniotomy ejaculatory pain and Largiader F. Gold standard for inguinal hernia repair:
pain-related sexual dysfunction. After this analysis, Shouldice or Lichtenstein? Hernia 1999; 3:117–120
7. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The
the authors concluded that postherniotomy genital
tension-free hernioplasty. Am J Surg 1989; 157:188–193
and ejaculatory pain that impairs sexual activity is 8. Shouldice EE. Surgical treatment of hernia. Ontar Med
of neuropathic origin and is anatomically related Rev 1945; 4:43
to the vas deferens and related structures [27]. 9. Peiper Ch, Ponschek N, Truong S, Schumpelick V. Ultra-
Summarizing these publications and our ex- sound-based volumetric evaluation of fluid retention af-
ter inguinal hernia repair. Surg Endosc 2000; 14:666–669
perimental results, we suggest some negative influ-
10. Johnsen SG. Testicular biopsy score count–a method for
ence by the foreign body reaction to the prosthetic registration of spermatogenesis in human testes: normal
mesh on the structures of the spermatic cord. values and results in 335 hypogonadal males. Hormones
Therefore, we caution against implanting poly- 1970; 1:2–25
38 Chapter 4 · Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats

11. Berndsen FH, Bjursten LM, Simanaitis M, Montgomery with a variant of polypropylene mesh. Urologe A 2003;
A. Does mesh implantation affect the spermatic cord 42:375–381
structures after inguinal hernia surgery? An experimental 26. Aasvang EK, Møhl B, Bay-Nielsen M, Kehlet H. Pain-related
study in rats. Eur Surg Res 2004; 36:318–322 sexual dysfunction after inguinal herniorrhaphy. Pain
12. Taneli F, Aydede H, Vatansever S, Ulman C, Ari Z, Uyanik 2006; 122:258–263
BS. The long-term effect of mesh bioprosthesis in inguinal 27. Aasvang EK, Møhl B, Kehlet: Ejaculatory pain: a specific
hernia repair on testicular nitric oxide metabolism and postherniotomy pain syndrome? Anesthesiology 2007;
apoptosis in rat testis. Cell Biochem Funct 2005;23:213– 107:298–304
220
13. Kolbe T, Lechner W. Influence of hernioplastic implants on
4 male fertility in rats. J Biomed Mater Res B Appl Biomater
2007; 81:435–440
14. Maciel LC, Glina S, Palma PC, Nascimento LF, Netto NR Jr.
Histopathological alterations of the vas deferens in rats
exposed to polypropylene mesh. BJU Int 2007; 100:187–
190
15. Lewis-Jones DI, Moreno de Marval M, Harrison RG. Im-
pairment of rat spermatogenesis following unilateral ex-
perimental ischemia. Fertil Steril 1982; 38:482–490
16. Kapral W, Kollaritsch H, Stemberger H. Correlation of
inguinal hernia and agglutinating sperm antibodies.
Zentralbl Chir 1990; 115:369–377
17. Matsuda T, Muguruma K, Horii Y, Ogura K, Yoshida O.
Serum antisperm antibodies in men with vas deferens
obstruction caused by childhood inguinal herniorrhaphy.
Fertil Steril 1993; 59:1095–1097
18. Akbulut G, Serteser M, Yucel A, Degirmenci B, Yilmaz S,
Polat C, San O, Dilek ON. Can laparoscopic hernia repair al-
ter function and volume of testis? Randomized clinical trial.
Surg Laparosc Endosc Percutan Tech 2003; 13:377–381
19. Uzzo RG, Lemack GE, Morrissey KP, Goldstein M. The ef-
fects of mesh bioprosthesis on the spermatic cord struc-
tures: a preliminary report in a canine model. J Urol 1999;
161:1344–1349
20. Fitzgibbons RJ Jr, Salerno GM, Filipi CJ, Hunter WJ, Watson
P. A laparoscopic intraperitoneal onlay mesh technique
for the repair of an indirect inguinal hernia. Ann Surg
1994; 219:144–156
21. LeBlanc KA, Booth WV, Whitaker JM, Baker D. In vivo study
of meshes implanted over the inguinal ring and exter-
nal iliac vessels in uncastrated pigs. Surg Endosc 1998;
12:247–251
22. Shin D, Lipshultz LI, Goldstein M, Barme GA, Fuchs EF,
Nagler HM, McGallum SW, Niederberger CS, Schoor RA,
Brugh VM 3rd, Honig SC. Herniorrhaphy with polypropyl-
ene mesh causing inguinal vasal obstruction: a prevent-
able cause of obstructive azoospermia. Ann Surg 2005;
241:553–558
23. Valenti G, Baldassarre E, Torino G. Vas deferens obstruc-
tion due to fibrosis after plug hernioplasty. Am Surg
2006; 72:137–138
24. Wingenbach O, Waleczek H, Kozianka J. Laparoscopic
hernioplasty by transabdominal preperitoneal approach.
Analysis and review in 267 cases. Zentralbl Chir 2004;
129:369–373
25. Langenbach M, Schmidt J, Lazika M, Zirngibl H. Urologi-
cal symptoms after laparoscopic hernia repair. Reduction

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5

The Effects of a Mesh Bioprosthesis


on the Spermatic Cord Structures
A. Goldenberg
40 Chapter 5 · The Effects of a Mesh Bioprosthesis on the Spermatic Cord Structures

Introduction Experimental Study 2

We performed two experimental studies in a dog In the second investigation we studied the effects
model [1, 2] and one clinical research study on the of polypropylene mesh implanted by inguinotomy
effects of synthetic mesh on fertility. in the spermatic cord, epididymis, and testis of
dogs [2].

Experimental Study 1
Methods
The first work developed by our group concerned
application of the mesh by video laparoscopy without Eighteen dogs were included (12–23 kg), separated
5 dissection of the inguinal region. The aim of this into three groups:
study [1] was to investigate the effects of the synthetic -Group A (n=7): left side (with mesh) vs. right side
mesh on the ductus deferens and testicle of dogs. (without mesh)
-Group B (n=7): left side (without mesh) vs. right
side (with mesh)
Methods -Group C (n=4): no surgical manipulation (control
group)
Ten adult male dogs were anesthetized, and a After being observed for 60 days, the animals were
2.5×3.5 cm2 polypropylene mesh was fixed in the subjected to bilateral removal of the spermatic
inguinal region in direct contact with the ductus cord, epididymis, and testis, which were submitted
deferens, using metallic staples without dissection for histological analysis. During the reoperation, a
of the region and, therefore, without manipula- macroscopic evaluation was performed.
tion. The right side, with no mesh, was the control.
The operating time was 15 min. The animals were
observed for 30 days, and then they were again Results
anesthetized and underwent new surgery, during
which the ductus deferens and testicle were re- On the mesh side, we noted 100% mesh adherence
moved and sent for histological analysis. to the posterior wall of the inguinal canal, as well
as adherence of the spermatic cord to the mesh.
Congestion of the pampiniform plexus was noted
Results in three animals.
Chronic inflammation and foreign body reac-
The histological sections of the testicle showed a tions in the spermatic cord were observed in 100%
focal reduction of spermatogenesis in 20% of the of the animals. On the side that was not implanted
animals and a degenerative process in 20%. In the with mesh, a chronic inflammatory reaction was
epididymis, chronic inflammation and seminifer- observed in 71% of the animals. All of the ani-
ous tubule dilatation were observed in 70%. A mals presented a chronic inflammatory reaction
chronic inflammatory process was found in 60% of in the deferent duct on the mesh side, and such
the vasa deferentia. a reaction was also present in 11 animals in the
side without the mesh. These alterations were not
found in group C.
Conclusion There was a considerable statistical reduction
in the average lumen diameter of the deferent duct
The polypropylene mesh in direct contact with the on the mesh side. In the epididymis and testis,
spermatic funiculus in dogs caused histological macroscopic and microscopic alterations were not
alterations, with minimal reduction of spermato- significant, although one animal showed a marked
genesis. reduction of spermatogenesis on the mesh side.

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Chapter 5 · The Effects of a Mesh Bioprosthesis on the Spermatic Cord Structures
41 5
Conclusion Acknowledgments

When in contact with the spermatic cord of I am grateful for the collaboration in my research
dogs, the polypropylene mesh caused an intense to Jaques Matone, Joaquim Ferreira de Paula, and
chronic inflammatory reaction and a significant Edgar Valente Lima Neto.
reduction in the diameter of the lumen of the
deferent duct.
References

Clinical Study 1. Goldenberg A, Matone J, Marcondes W, Focchi G. Effects


of the polypropylene mesh in the testicle, epididymis and
ductus deferens of dogs. Acta Cir Bras 2001; 16(4)
We performed one more study to evaluate testicu- 2. Goldenberg A, Ferreira de Paula J. Effects of the poly-
lar volume and arterial flow in patients undergoing propylene mesh implanted through inguinotomy in the
surgical correction for inguinal hernia with a poly- spermatic funiculus, epididium and testis of dogs. Acta
propylene prosthesis [3]. Cir Bras 2005; 20(6):461–467
3. Lima Neto EV, Goldenberg A, Jucá MJ. Prospective study
on the effects of a polypropylene prosthesis on testicular
volume and arterial flow in patients undergoing surgical
Methods correction for inguinal hernia. Acta Cir Bras 2007; 22(4):
266–271
This was an observational prospective clinical
study of 39 male patients with unilateral inguinal
hernia of Nyhus types IIIa and IIIb who under- Discussion
went surgical correction with implantation of a
polypropylene prosthesis by means of the Lichten- Amid: Is there any direct contact between mesh
stein technique. The patients were evaluated us- and the vas deferens during your laparoscopic ap-
ing Doppler ultrasound before the operation and proach?
selectively 3 and 6 months after the operation. The Goldenberg: No, there was no dissection and
variables studied were testicular volume, systolic therefore no direct contact.
and diastolic velocity, resistance index, and pulsa-
tility index.

Results

No statistically significant alterations in the stud-


ied variables were observed over the course of
time: testicular volume (p=0.197), systolic ve-
locity (p=0.257), diastolic velocity (p=0.554), re-
sistance index (p=0.998), and pulsatility index
(p=0.582).

Conclusion

No alterations in testicular volume or arterial flow


were observed over a 6-month period in patients
who underwent surgical correction for inguinal
hernia using a polypropylene prosthesis.
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6

Influence of Prosthetic Implants


on Male Fertility in Rats
T. Kolbe and W. Lechner
44 Chapter 6 · Influence of Prosthetic Implants on Male Fertility in Rats

Introduction

In an effort to find a suitable material for tension-


free repair of inguinal hernias, a variety of natural
and synthetic materials have been used [1]. Cur-
rently, three prosthetic materials are widely used for
repairing inguinal hernias: polyester, polypropylene,
and expanded polytetrafluoroethylene [2]. Despite
their wide acceptance and use in countless surgeries
worldwide, little data exist regarding the effects of
the mesh bioprosthesis on the adjacent spermatic
cord structure and function, particularly the ductus
deferens. Since it was shown that the weight of the
6 implanted material corresponds to the postsurgical
inflammatory reaction [3–5], partially absorbable
meshes have been developed to reduce the amount
of foreign material staying in the patient’s body.
This study explored the vulnerability of the
ductus deferens to mesh-induced inflammation
and shrinkage after hernia repair in a rodent model.
In our study we tested the influence on male fertil-
ity of a widely used mesh of 100% polypropylene
(Prolene) and a mesh containing a mixture of 50%
polypropylene and 50% polyglactin (Vypro II). The
polyglactin component, which should be resorbed
within 56–70 days, makes the mesh more flexible
and reduces the implant’s weight. The bigger pores
are regarded to be advantageous concerning the
inflammatory reaction after implantation [6–8].
Due to the ethical constraints of studies in hu-
mans, we used rats as an animal model to test the
vulnerability of the ductus deferens to the materi-
als mentioned above. Because there are reports of
special sensitivity of the premature male reproduc-
tive organs to surgical manipulations [9, 10], we
tested both mature and premature male rats for
short-term and long-term histological reactions ⊡ Fig. 6.1. Reproductive tract of male rat and implantation
and for subsequent reproductive performance. of meshes

Material and Methods tissue. Each of the six groups (Prolene juvenile, Pj;
Prolene adult, Pa; Vypro II juvenile, Vj; Vypro II
Two types of implants (Prolene and Vypro II, both adult, Va; control juvenile, Cj; control adult, Ca)
Ethicon, Germany) in the size of 2.25 cm2 were consisted of 10 animals.
used in juvenile and adult Hsd:Sprague Dawley SD The meshes were surgically wrapped around
rats (8 weeks and 12 weeks, respectively). In two the ductus deferens on each side to ensure direct
control groups (juvenile and adult male rats), the contact with the spermatic cord and were fixed
ducti were only bluntly separated from adherent with sutures to remain in position (⊡ Fig. 6.1).

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Chapter 6 · Influence of Prosthetic Implants on Male Fertility in Rats
45 6
4 Weeks After Start:
Histology

The implants and the adjacent part of the ductus


deferens from one side of each male rat were re-
moved surgically for histological examination of
acute inflammatory reaction.
Staining was achieved with mouse antihuman
proliferating cell nuclear antigen (PCNA) for de- a
tection of cell proliferation, rabbit antihuman fac-
tor VIII (Von Willebrand factor) for detection of
angiogenic proliferation, and mouse antihuman
bcl-2 (oncoprotein) for cancerogenic reaction.
Counterstaining was done with Hemalaun.

3–4 Months After Start:


Mating Test

Three months after implantation, each male was b


mated with two or three adult females. Two days
after positive vaginal plug control, the females
were euthanized, and oocytes or embryos were
flushed from the oviducts and uteri. The relation-
ship of unfertilized and degenerated oocytes to
morphologically intact embryos was recorded.

4 Months After Start: Histology

The implant on the opposite side was removed


after euthanasia for histological examination of c
chronic inflammatory reactions using the same
methods as described above.

Results

Histological Examination

Hemalaun Staining
Four weeks after treatment, two animals in the Pj
group showed granulomatous inflammatory reac-
tions with sperm deposits in the connective tissue d
due to injuries of the wall of the ductus deferens.
Other rats in groups Pj and Pa showed incisions ⊡ Fig. 6.2. a The two different implants. b Sperm granuloma.
of the muscularis. There was enhanced production c Minor inflammation around a Prolene fiber (arrow). d Lumen
of collagen fibers at the edges of the Prolene im- of the ductus slightly depressed by Vypro II fibers (arrows)
46 Chapter 6 · Influence of Prosthetic Implants on Male Fertility in Rats

plants. Areas of inflammation were visible around


the Vypro II implants in groups Vj and Va, with
many multinuclear giant cells (⊡ Fig. 6.2). There
was no visible inflammatory reaction in the mu-
cosa or blockage of the spermatic cord.
In the samples taken after 4 months, we ob-
served no profound differences from the first ex-
amination after 4 weeks. In the Prolene groups,
there were incisions of the muscularis due to im-
plant fibers, but no enhanced cellular reaction or
inflammation-associated changes occurred. Two
rats in the Pj group and three in the Pa group
showed multinuclear giant cells. In the Vypro II
6 groups, only the nonabsorbable component of the
meshes was present. In some cases, the round lu-
men of the ductus deferens was slightly deformed,
comparable to the Prolene groups, but without the
incisions seen in the Pj and Pa groups.

PCNA Reaction
Serosa Cells
The staining for proliferative cells revealed in-
creased inflammatory reactions after 4 months
compared with the values after 4 weeks after treat-
ment (⊡ Fig. 6.3a). While there was only a tendency
in the Vypro and Prolene groups for more PCNA-
positive cells after 4 weeks, this difference was
significant after 4 months (⊡ Fig. 6.3b). There was
no significant difference between the mesh groups.
We did not observe an age effect.

Mucosal Cells
Between the mesh groups and controls, there
was no significant difference in the percentage of
PCNA-positive cells either after 4 weeks or after
4 months. Several groups showed high variation
among individuals and thus a high standard of
group values.
⊡ Fig. 6.3. Proliferating cell nuclear antigen (PCNA)-positive
cells in different cell layers 4 weeks and 4 months after im-
Von Willebrand Factor Staining plantation of meshes around the spermatic cord (mean and
Staining for Von Willebrand factor revealed an SE). a After 4 weeks. b After 4 months
increase in the mean number of blood vessels in
all groups between sampling points (⊡ Fig. 6.4).
This proliferation ranged from 1.6% (Cj group) to
36% (Pj group). However, due to high individual Bcl-2 Staining
variation, there was no statistically significant dif- There was no sign of oncogenic activity by expres-
ference (as shown by analysis of variance) between sion of bcl-2 after either 4 weeks or after 4 months
the experimental groups. compared with positive controls.

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Chapter 6 · Influence of Prosthetic Implants on Male Fertility in Rats
47 6
No. of blood vessels per area

25

20
counted

15 after 4 weeks
10 after 4 months

0
Cj Ca Pj Pa Vj Va
Experimental Groups

⊡ Fig. 6.4. Number of blood vessels per area counted at 4 weeks and 4 months (mean and range; minimum to maximum)

Mating Test In our investigation, we used both materials in


both juvenile and adult male rats. A direct mating
The flushing of embryos resulted in mean embryo test revealed no statistically significant differences
numbers from 7.7 to 14.7 in the experimental between the two different materials or the different
groups. These were compared to the total number ages. Histological examination of spermatic cord
of unfertilized or fragmented oocytes and embryos explants stained with PCNA showed long-term in-
(range 13.0–16.3). All groups exhibited one to flammatory reactions in the adjacent serosa but not
three males with decreased or restricted fertility, in the mucosa. This effect was independent of the
but there were no differences between groups. material applied. This effect might be induced by
There was no indication of a negative influence on the smaller pore size of the Prolene mesh, resulting
male fertility due to one of the implanted meshes in enhanced colonization with macrophages after
(analysis of variance). 90 days [12, 13] and resorption of the polyglactin
part in the Vypro II mesh. However, in both cases
the mucosa was not involved.
Discussion This result is in contrast to that found by Ro-
sch et al. [14], but it confirms Berndsen et al. [15].
Open and laparoscopic mesh-based techniques By measuring testicular hormonal function, the
dominate inguinal hernia repairs today. Research is latter authors also confirmed that polypropylene
currently focusing on the search for suitable mesh and polypropylene/polyglactin meshes did not in-
materials with regard to inflammatory response, fluence male fertility in the rat model, as had been
chemical properties, and applicability [2]. The concluded in another study [16]. The sharp edges
more rigid polypropylene mesh is preferred for and the unusual mode of application (wrapping
laparoscopic hernia repair because it unfolds easily around the spermatic cord) might be responsible
after introduction into the abdomen through the for the observed sperm granulomas in two male
endoscope. A disadvantage is the heavy shrinkage rats and for the mesh incisions into the muscularis
of this material in vivo, which has been reported and granulosa in some rats of the Prolene group.
both in humans [4] and in animal experiments [5]. From this point of view, the 50% absorbable Vy-
In contrast, other authors reported an even greater pro II mesh with softer material properties seems
shrinkage of the more flexible Vypro II mesh (28%) to be more difficult to apply, but according to the
compared with a heavyweight polypropylene mesh results of other investigations [17], it causes less
(Atrium, 12%) [11]. irritation to the surrounding tissue.
48 Chapter 6 · Influence of Prosthetic Implants on Male Fertility in Rats

In summary, we did not observe a reduction in 14. Rosch R, Junge K, Quester R, Klinge U, Klosterhalfen B,
fertility of male rats compared with the controls, Schumpelick V (2003) Vypro II mesh in hernia repair: im-
pact of polyglactin on long-term incorporation in rats.
even after direct wrapping of synthetic meshes of
Eur Surg Res 35:445–450
two different types around the ducti deferentia. 15. Berndsen FH, Bjursten LM, Simanaitis M, Montgomery A
Therefore, we conclude that neither mesh has a (2004) Does mesh implantation affect the spermatic cord
negative influence on male fertility. structures after inguinal hernia surgery? An experimental
study in rats. Eur Surg Res 36:318–322
16. Taneli F, Aydede H, Vatansever S, Ulman C, Ari Z, Uyanik
BS (2005) The long-term effect of mesh bioprosthesis
References
in inguinal hernia repair on testicular nitric oxide me-
tabolism and apoptosis in rat testis. Cell Biochem Funct
1. The EU Trialists Collaboration (2002) Repair of groin her- 23:213–220
nia with synthetic mesh: meta analysis of randomized 17. Friis E, Lindahl F (1996) The tension-free hernioplasty in a
controlled trials. Ann Surg 235:322–332 randomized trial. Am J Surg 172:315–319
2. Nathan JD, Pappas TN (2003) Inguinal hernia: an old con-
6 dition with new solutions. Ann Surg 238:148–157
3. Prior MJ, Williams EV, Shukla HS, Phillips S, Vig S, Lewis M
(1998) Prospective randomized controlled trial compar- Discussion
ing Lichtenstein with modified Bassini repair of inguinal
hernia. J R Coll Surg Edinb 43:82–86
Schumpelick: I think this is the first study dealing
4. Schumpelick V, Arlt G, Schlachetzki A, Klosterhalfen B (1997)
Chronic inguinal pain after transperitoneal mesh implanta- with fertility.
tion. Case report of net shrinkage. Chirurg 68:1297–1300 Kolbe: Let me give at first one short comment on
5. Klinge U, Klosterhalfen B, Muller M, Ottinger AP, Schumpe- this animal model. I believe that the rat model is a
lick V (1998) Shrinking of polypropylene mesh in vivo: an very good model to investigate tissue reaction. That
experimental study in dogs. Eur J Surg 164:965–969
seems to be comparable to the human situation. It
6. Klinge, U, Klosterhalfen B, Conze J, Limberg W, Obolenski
B, Ottinger AP, Schumpelick V (1998) A modified mesh seems not to be a good model for investigating tes-
for hernia repair that is adapted to the physiology of the ticular function because there are some differences
abdominal wall. Eur J Surg 164:951 from the human being. The rodent can retract the
7. Klosterhalfen B, Junge K, Klinge U (2005) The lightweight testicles into the body cave with different tempera-
and large porous mesh concept for hernia repair. Expert
tures and conditions for spermatogenesis.
Rev Med Devices 2:103–117
8. Hagerty RD, Salzmann DL, Kleinert LB, Williams SK (2000)
Cellular proliferation and macrophage populations as-
sociated with implanted expanded polytetrafluoro-ethyl-
ene and polyethyleneterephthalate. J Biomed Mater Res
49:489–497
9. Shandling B, Janik JS (1981) The vulnerability of the vas
deferens. J Ped Surg 16:461–464
10. Barrat C, Seriser F, Arnoud R, Trouette P, Champault G
(2004) Inguinal hernia repair with beta glucan-coated
mesh: prospective multicenter study (115 cases)–prelimi-
nary results. Hernia 8:33–38
11. Scheidbach H, Tamme C, Tannapfel A, Lippert H, Kocker-
ling F (2004) In vivo studies comparing the biocompat-
ibility of various polypropylene meshes and their han-
dling properties during endoscopic total extraperitoneal
(TEP) patchplasty: an experimental study in pigs. Surg
Endosc 18:211–220
12. Rosch R, Junge K, Schachtrupp A, Klinge U, Klosterhalfen
B, Schumpelick V (2003) Mesh implants in hernia repair.
Inflammatory cell response in a rat model. Eur Surg Res
35:161–166
13. Schumpelick V, Klinge U (2003) Prosthetic implants for
hernia repair. Br J Surg 90:1457–1458

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7

What Can We Do To Decrease the Risk


of Vas Deferens Injury due to Inguinal
Hernioplasty?
P. Witkowski
50 Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury due to Inguinal Hernioplasty?

Introduction of stress urinary incontinence [4]. Erosion of the


vagina has also been reported [8, 9]. As a remedy,
The implantation of polypropylene mesh in ingui- a new polypropylene sling with an absorbable cen-
nal hernia repair surgery has been a tremendous tral suburethral part was developed to separate the
breakthrough. It has significantly reduced the her- polypropylene part of the sling from the urethra
nia recurrence rate from 15–20% to 0.5–5% and and vagina [10].
therefore has decreased the rate of spermatic cord, All of the complications described above are
vas deferens, and testicular artery injury due to re- recognizable on obvious clinical presentation and
operation for recurrence [1]. We have only limited result from placement of the mesh in close prox-
information, however, about the long-term effects imity to the organs.
of polypropylene mesh implantation on the vas Therefore, it is reasonable to expect that a
deferens, especially with regard to fertility. structure as delicate as the vas deferens could also
Despite new developments, polypropylene be damaged or occluded if a mesh were placed
mesh remains the optimal and most commonly close enough to it, especially if left under tension
used material for inguinal hernioplasty. This mesh or pressure.
7 stimulates a pronounced chronic inflammatory Animal studies provide more arguments for
reaction with connective tissue formation that in- an increased risk of vas injury when polypropyl-
corporates the prosthesis into surrounding tissue. ene mesh is used for the repair. In several studies,
Although such scar formation fills out the hernia mesh was found to be adherent to the spermatic
defect and effectively prevents hernia recurrence, cord throughout its inguinal course, leading to
it may ultimately cause damage to the adherent significant foreign body reaction in all animals [2,
organs. This inflammatory process is clinically rel- 11–13]. Histology showed fibrosis, extensive skel-
evant because it remains active even years after etal muscle degeneration, and histiocytic inflam-
mesh implantation [2]. mation along the outer part of the cord [11, 14].
Additionally, the thick muscular layer of the vas
was more prominently attenuated after mesh her-
Is There a Risk for a Vas Deferens Injury nia repair than after Shouldice repair in a canine
After Mesh Hernioplasty? experiment [11]. This attenuation is important
because the vas is no longer considered a passive
In my opinion, we have enough clinical as well as conduit through which the ejaculate travels. The
experimental data from animal studies to confirm rich adrenergic innervation, the complexity of the
this risk. Injury may occur in the postoperative muscle layers of the vas, and the metabolically ac-
period because of a chronic foreign body reaction tive vasal epithelium all suggest a very active role
involving tissue surrounding the implanted mesh, in sperm transport, which may be altered by the
which may also include the spermatic cord and vas perivasal fibrosis attributable to the mesh [11].
deferens. When a mesh was placed in proximity, the lumen
Clinical experience indicates that a polypro- of the vas was narrowed compared with nonsurgi-
pylene mesh cannot be safely implanted in contact cal controls [12].
with any visceral or retroperitoneal organs, espe- Other studies also suggest that even if fibrosis
cially if placed under pressure or tension. Extensive around the vas deferens and within its wall does
fibrosis around the mesh can trap and damage in- not lead to reduction of the lumen of the vas, it
guinal nerves, the intestine, or the urinary bladder may cause functional obstruction with dilatation
[3–5]. The mesh can even erode into the wall or of the proximal segment along with degenerative
lumen of those organs, leading to pain, infection, changes in mucosa and repression of spermato-
small bowel obstruction, or enterocutaneous fis- zoa [11, 14]. Foreign body reaction around the
tula formation [3–7]. The same process may even mesh may compromise blood flow within the cord
lead to stenosis or obstruction of the urethra after and eventually compromise fertility [15]. Conges-
polypropylene tape suspension for the treatment tion of the pampiniform plexus was noted in 20%

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Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury
51 7
of animals after a Lichtenstein procedure, with by that fact that most patients do not test their
spermatic cord vein thrombosis in up to 33% of fertility before or after surgery, and occlusion can
cases after an open preperitoneal approach [2, 14]. develop not only shortly after surgery but also
Mesh repair led to decreases in arterial perfusion years later, when a patient has finished his procre-
and testicular temperature and also reduced the ative activity.
proportion of seminiferous tubules with regular Furthermore, we do not have any noninvasive
spermatogenesis [2]. Focal fibrinoid necrosis of methods to detect vas injury or obstruction or to
the deferent duct wall was also reported [2]. screen asymptomatic patients.
The above results were observed in animals Because we have animal experimental data in-
shortly after mesh implantation (weeks or months), dicating that fibrosis around the implanted mesh
whereas in humans, the mesh stays in the body for compromises vas deferens function, and knowing
years and may cause much more extensive degen- that the vas can be occluded when mesh is placed
erative changes. in proximity, as seen with urethral or small bowel
Finally, several clinical reports conclude that obstruction, we cannot exclude the possibility that
occlusive injury to the vas deferens resulted from symptomatic patients from case reports are only
mesh implantation [7, 16–20]. Because these re- the tip of the iceberg and that there are asymp-
ports represent only single cases, until recently tomatic patients with vas deferens injury and oc-
they had only anecdotal value. But a recent multi- clusion after inguinal hernioplasty. The majority
center study has drawn attention to the possibility of patients may have this complication and may
that vas deferens injury may take place more com- be completely unaware of it because they either do
monly than we think [21]. The authors presented not test their fertility or they remain fertile because
14 cases of obstructive azoospermia leading to in- of an uncompromised contralateral sex organ.
fertility because of bilateral or unilateral vas occlu-
sion, with simultaneous, but different, pathology
of the reproductive organs on the contralateral How Can We Assess the Risk?
side. Mesh-related fibrosis as a cause of vas occlu-
sion was verified during surgical revision of the Autopsies of patients who received inguinal mesh
inguinal region [21]. Mechanical injury of the vas repair might give some estimates. Unfortunately,
by the edge of the mesh has also been blamed as a prospective studies with fertility monitoring be-
possible cause of spermatic granuloma [20]. Fur- fore and after the procedure put a significant
ther reports suggest that vas obstruction may lead burden on patients and do not seem feasible at the
to increased serum levels of antisperm antibody moment [23].
even without sperm granulomas, which can ad-
ditionally compromise fertility [15, 22].
What Can We Do Now?

How Great Is the Risk of Vas Injury Some surgeons may choose not to change anything
After Mesh Hernioplasty? and to continue using current surgical techniques
until the actual risk rate is known. For the time
Today we cannot estimate the risk because we do being, I think that for patients whose procreative
not know how many patients are affected. This ability is of great concern, we should tailor our sur-
is mainly because of poor clinical presentation of gical approach to minimize the risk of vas injury
the injury. Isolated, unilateral occlusion of the vas without compromising repair results. These candi-
is completely asymptomatic. Infertility is the only dates would include young patients with bilateral
potential symptom, and it occurs only with bilat- hernia and those with compromised sex organs
eral occlusion or with unilateral injury in a patient and contralateral hernia.
with contralateral sex organ pathology. Diagnosis Careful handling of the spermatic cord, in-
of mesh-related vas injury is further complicated cluding the vas deferens, in order to avoid direct
52 Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury due to Inguinal Hernioplasty?

intraoperative injury of this structure remains a


constant principle of safe and efficient surgical
technique [15]. To minimize the risk of vas occlu-
sion, the general rule would be to avoid direct con-
tact between the mesh and the vas deferens [24]:
▬ In the preperitoneal space the vas deferens
is bare, so we may choose to avoid implant-
ing mesh there, both in the posterior (lap-
aroscopic, Nyhus, Stoppa, transabdominal
preperitoneal, totally extraperitoneal repair)
and anterior preperitoneal approaches (Rives,
Kugel, Prolene Hernia System repair).
▬ Mesh plug insertion in the deep inguinal ring
for indirect defects causes extensive fibrosis
and may also involve the bare vas deferens;
7 therefore, the plug is not advised in this loca-
tion (Rutkow technique) [24].
▬ In the course of the inguinal canal, the vas
runs in the spermatic cord and is better pro-
tected by the surrounding internal spermatic ⊡ Fig. 7.1. Placement of the mesh on the posterior of the
fascia and cremaster. Therefore, it seems rea- inguinal canal

sonable not to excise the cremaster but instead


to spare it and close it with absorbable suture
after hernia sac dissection and reduction. placed freely in subcutaneous tissue. Therefore,
▬ Placement of the mesh on the posterior wall the risk of damage due to fibrosis surrounding the
of the inguinal canal is better (Lichtenstein or prosthesis is eliminated.
Trabucco technique) because the transversalis Additionally, polypropylene mesh is placed flat
fascia can separate the mesh from bare vas between two fascial layers, the transversalis fascia
running in the preperitoneal space. and the oblique aponeurosis, which limits fibrotic
tissue ingrowth only to the intrafascial space. Fi-
The disadvantage of the Lichtenstein operation, brosis penetrating the mesh glues the fascial layers
however, is that the spermatic cord is placed within together, creating a uniform, triple-layer (fascia–
the inguinal canal, where it is usually compressed mesh–fascia) solid scar, which effectively rein-
between the mesh and the aponeurosis of the ex- forces the abdominal wall around the deep ingui-
ternal oblique abdominal muscle. In such limited nal ring and prevents recurrence. After such repair,
space, fibrosis around the mesh may still involve oblique passage of the spermatic cord through the
the spermatic cord and compromise the vas def- inguinal canal can thus be avoided; it is not essen-
erens. tial for effectiveness of the repair, as in traditional
Therefore, we may modify our technique; after suture operations. This approach was developed
placing the mesh on the posterior wall of the ingui- by Trabucco in his sutureless technique, in which
nal canal, we can reapproximate the aponeurosis of a preshaped polypropylene mesh with flat-shape
the external oblique muscle with the sutures below memory is placed without suture fixation on the
(instead of above) the spermatic cord, as described posterior wall of the inguinal canal [25]. Long-
in the Trabucco repair [25] (⊡ Figs. 7.1–7.3). term results of this approach indicate that it is
This modification can be easy applied to the as effective as any other tension-free technique
Lichtenstein operation, as has been previously sug- [27–30]. This technique is especially popular in
gested [26]. In this way, the spermatic cord is sepa- Italy, with thousands of patients and years of expe-
rated from the mesh with additional fascia and rience. A randomized study could be organized to

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Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury
53 7
period as the mesh contracts. It may compromise
the vas as well as blood vessels within the cord.
Moreover, the sharp edge of the mesh on which
the spermatic cord directly kinks upon entering
the inguinal canal from the deep inguinal ring is
considered a common place for vas injury. A flat,
preshaped onlay mesh with a hole for the sper-
matic cord decreases contact between the mesh
and the cord without compromising the effective-
ness of the Lichtenstein technique. The efficacy of
this approach was clearly proven by the Trabucco
technique and other repairs using a preshaped
onlay mesh with a preformed hole for the sper-
⊡ Fig. 7.2. Closure of the aponeurosis of the external oblique matic cord. In the above proposed approach, direct
muscle below (instead of above) the spermatic cord kinking of the cord over the mesh is avoided, and
the cord instead folds over the fascia of the exter-
nal aponeurosis while entering the subcutaneous
space. The proposed surgical techniques comply
with the principles of the tension-free operation
and can be easily implemented.
In summary, although the actual rate of vas
deferens injury due to fibroblastic inflammation
around polypropylene mesh is not yet known,
there is strong experimental and clinical evidence
that such processes can and do take place.
Therefore, until the risk is fully investigated, all
patients with any known compromise to their re-
productive health or with concerns about fertility
can be offered a surgical technique that minimizes
the potential risk without diminishing all the ad-
⊡ Fig. 7.3. Closure of the lateral part of the aponeurosis of the vantages of tension-free hernia repair. Isolating
external oblique muscle; the medial part of the aponeurosis is the spermatic cord from the mesh by placing it
already closed below the spermatic cord above (not below) the aponeurosis of the oblique
abdominal muscle seems to be an easy, applicable,
and effective solution.
assess the effectiveness of such modification of the
Lichtenstein technique, but in our opinion, a suf-
ficient amount of indirect confirmatory evidence References
exists. Professor Smeds from Sweden started using
1. Fitzgibbons RJ Jr. (2005) Can we be sure polypropylene
this approach after our recent publication [26] a
mesh causes infertility? Ann Surg 241:55–561
year ago and found only one (0.3%) recurrence 2. Peiper Ch, Klinge U, Junge K, Schumpelick V (2006) Is
after 300 repairs (personal communication). there a risk of infertility after inguinal mesh repair? Ex-
In my opinion, a shutter-valve effect of mesh perimental study in pig and the rabbit. Hernia 10:7–12
tails sutured together and wrapping the cord is 3. Amid PK (2004) Radiologic images of meshoma: a new
phenomenon causing chronic pain after prosthetic repair
dangerous because it unnecessarily enhances con-
of abdominal wall hernias. Arch Surg 139:1297–1298
tact between the surface of the mesh with the 4. Chuback JA, Singh RS, Sills C, et al. (2000) Small bowel ob-
cord, creating a cuff that contracts substantially struction resulting from mesh plug migration after open
around the spermatic cord in the postoperative inguinal hernia repair. Surgery 127:475–476
54 Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury due to Inguinal Hernioplasty?

5. Agrawal A, Avill R (2005) Mesh migration following repair 21. Shin D, Lipshultz LI, Goldstein M, Barmé GA, Fuchs EF,
if inguinal hernia: a case report and review of literature. Nagler HM, McCallum SW, Niederberger CS, Schoor RA,
Hernia 10:79–82 Brugh VM 3rd, Honig SC (2005) Herniorrhaphy with poly-
6. Jeans S, Williams GL, Stephenson BM (2007) Migration propylene mesh causing inguinal vassal obstruction: a
after open mesh plug inguinal hernioplasty: a review of preventable cause of obstructive azoospermia. Ann Surg
the literature. Am Surg 73:207–209 241:553–558
7. Weber-Sánchez A, García-Barrionuevo A, Vázquez-Frias 22. Matsuda T, Muguruma K, Horii Y, Ogura K, Yoshida O
JA, Cueto-Garcia J (1999) Laparoscopic management of (1993) Serum antisperm antibodies in men with vas def-
spermatic cord entrapment after laparoscopic inguinal erens obstruction caused by childhood inguinal hernior-
herniorrhaphy. Surg Laparosc Endosc Percutan Tech rhaphy. Fertil Steril 59:1095–1097
9:296-9 23. Agarwal BB, Sinha BK, Mahajan KC (2008) The risk of com-
8. Sweat SD, Itano NB, Clemens JQ, et al. (2002) Polypropyl- municating TEP-related infertility risk is an opportunity
ene mesh tape for stress urinary incontinence: complica- and not a »Cinderella concern« anymore. Surg Endosc
tions of urethral erosion and outlet obstruction. J Urol 22:1557–1558
168:144–146 24. Valenti G, Baldassarre E (2006) Vasal obstruction after
9. Dunn JS Jr, Bent AE, Ellerkman RM et al. (2004) Voiding hernioplasty: the importance of surgical strategy in pre-
dysfunction after surgery for stress incontinence: litera- venting azoospermia. Ann Surg 244:160; author reply
ture review and survey results. Int Urogynecol J Pelvic 160
7 Floor Dysfunct 15:25–31
10. Trabucco AF, Blitstein J (2004) T-sling for the treatment of
25. Trabucco EE, Trabucco AF (2002) Tension-free, sutureless,
preshaped mesh hernioplasty. In: Nyhus LM, Condon RE
stress urinary incontinence. Am J Urol Rev 12:583–588 (eds) Hernia, 5th edn. Lippincott Williams & Wilkins, Phila-
11. Uzzo RG, Lemack GE, Morrissey KP, Goldstein M (1999) delphia, pp 159–164
The effects of mesh bioprosthesis on the spermatic cord 26. Witkowski P, Trabucco EE (2007) Is there an increased
structures: a preliminary report in a canine model. J Urol risk of the vas deferens occlusion after meshes inguinal
161(4):1344–1349 hernioplasty and what can we do about it? Ann Surg.
12. Goldenberg A, Paula JF (2005) Effects of the polypropyl- 245:153–154
ene mesh implanted through inguinotomy in the sper- 27. Trabucco EE, Trabucco AF (1998) Flat plug and mesh
matic funiculus, epididium and testis of dogs. Acta Cir hernioplasty in the »inguinal box«: description of the
Bras 20(6):461–467 surgical technique. Hernia 2:133–138
13. Berndsen FH, Bjursten LM, Simanaitis M, Montgomery A 28. Adamonis W, Witkowski P, Smietanski M, et al. (2006) Is
(2004) Does mesh implantation affect the spermatic cord there a need for a mesh plug in inguinal hernia repair?
structures after inguinal hernia surgery? An experimental Randomized, prospective study of the use of Herta 1
study in rats. Eur Surg Res 36(5):318–322 mesh compared to PerFix Plug. Hernia 10:223–228
14. Maciel LC, Glina S, Palma PC, Nascimento LF, Netto NR 29. Cucci M, De Carlo A, Di Luzio P, et al. (2002) The Trabucco
Jr. (2007) Histopathological alterations of the vas def- technique in the treatment of inguinal hernias: a six-year
erens in rats exposed to polypropylene mesh. BJU Int experience. Minerva Chir 57:457– 459
100:187–190. Erratum in: Costa Nascimento FC [corrected 30. Testini M, Miniello S, Piccinni G, et al. (2002) Trabucco ver-
to Nascimento, Luiz FC] (2007) BJU Int 100:481 sus Rutkow versus Lichtenstein techniques in the treat-
15. Ridgway PF, Shah J, Darzi AW (2002) Male genital tract ment of groin hernia: a controlled randomized clinical
injuries after contemporary inguinal hernia repair. BJU Int trial. Minerva Chir 57:371–376
90:272–276
16. Valenti G, Baldassarre E, Torino G (2006) Vas deferens ob-
struction due to fibrosis after plug hernioplasty. Am Surg
72:137–138 Discussion
17. Nagler HM, Belletete BA, Gerber E, Dinlenc CZ (2005)
Laparoscopic retrieval of retroperitoneal vas deferens in Deysine: The previous study did not show much
vasovasostomy for postinguinal herniorrhaphy obstruc-
damage caused by the mesh. The differences were
tive azoospermia. Fertil Steril 83:1842
18. Meacham RB (2002) From androlog. Potential for vasal not statistically significant in most cases. So we
occlusion among men after hernia repair using mesh. J don’t have any hard data to prove anything at this
Androl 23:759-761 time. I would suggest that until we have more hard
19. Aasvang EK, Kehlet H (2008) Postherniotomy dysejacula- data, human hard data, we should restrain the
tion: successful treatment with mesh removal and nerve
kind of language that we use when we express our
transection. Hernia 12:645–647
20. Silich RC, McSherry CK (1996) Spermatic granuloma. An impressions.
uncommon complication of the tension-free hernia re- Köckerling: I have to speak for the endoscopic
pair. Surg Endosc 10:537–539 procedure. At the moment, we really have no data,

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Chapter 7 · What Can We Do To Decrease the Risk of Vas Deferens Injury
55 7
even no clinical data, showing that there is really
a higher problem for vas deferens injury or any
other influence on that system due to endoscopic
inguinal hernia repair. So I wouldn’t go so far as
to exclude this technique in younger patients who
are fertile. Maybe we will have some problems.
We should carefully look at those problems, learn
how to avoid them, and choose the right mesh,
but we shouldn’t go so far as to exclude all mesh
procedures.
Kehlet: I think we are at the state where we can
say that we should not dissect the cremaster from
the cord.
Amid: We have to understand that if we use a mesh
and we don’t remove the cremastic muscle, none of
these potential problems will occur.
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8

The Long-Term Effect on Testicular


Function of a Mesh Bioprosthesis Used
for Inguinal Hernia Repair

H. Aydede
58 Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis Used for Inguinal Hernia Repair

Introduction were housed in a temperature- and light-controlled


environment with ad libitum access to water and rat
Polypropylene mesh currently finds widespread use food pellets for 3 days before the study. All experi-
throughout the world in hernia repair, as it is well mental procedures were approved by the Experi-
tolerated by the body and allows tissue ingrowth into mental Animal Research Ethics Committee of the
the prosthesis [1]. Experimentally, all meshes cause Faculty of Medicine. All surgical procedures were
an initial inflammatory tissue response in the recipi- performed under general anesthesia administered
ent after implantation [2]. Interestingly, in most clin- by intramuscular injection of ketamine and xylazine
ical studies in humans, these meshes are described as hydrochloride, employing sterile techniques.
inert materials, but systematic morphological exami-
nations of the long-term effects of meshes commonly
used for hernia repair in humans are rare [3]. Experimental Design
Nitric oxide (NO), a freely diffusible, water- and
lipid-soluble molecule, is formed from L-arginine The animals were randomly allocated into two
and molecular oxygen by a family of nitric oxide groups, each containing 20 rats. In group 1, the op-
synthases [4]. In the testis, nitric oxide synthase eration was performed using an infrainguinal inci-
(NOS) from endothelial cells (eNOS) is expressed sion above the scrotum, and the inguinal anatomy
in the Leydig cell, Sertoli cell, spermatocyte, and was explored. The left spermatic cord was elevated,
8 spermatid [5]. Expression of inducible NO synthase and a 0.5×1.0-cm polypropylene mesh (Surgipro,
(iNOS) requires transcriptional activation, which is United States Surgical, Norwalk, CT, USA) was
induced by various combinations of cytokines [6]. placed behind the left inguinal spermatic cord.
The upregulation of NOS leads to excessive NO pro- To avoid displacement, the mesh was sutured to
duction for prolonged periods of time and accounts aponeurotic tissue behind the spermatic cord us-
for oxyradical-mediated damage [6]. Although little ing 4/0 polypropylene. In group 2, the sham-op-
is known about the mechanism of its toxicity in erated controls, the left inguinal spermatic cord
germ cell injury from testicular ischemia, NO is was elevated and left in place with no further ma-
an important mediator of cell death through either nipulations. An intracardiac blood sample (1 ml)
apoptosis or necrosis, depending on the intensity was obtained for biochemical analysis from both
and duration of injury [7]. groups during the preoperative period.
The aim of the present study was to investigate All animals were housed in standard condi-
long-term effects of mesh implantation on testicular tions in the experimental research laboratory for
hormone function and NO metabolism [8]. Testicu- 6 months. After 6 months, before the rats were
lar hormone function was evaluated by assessments sacrificed, a 2-ml sample of intracardiac blood was
of serum luteinizing hormone (LH) and follicle- taken, and both testes were removed for examina-
stimulating hormone (FSH) levels. Testicular NO tion. All testes were divided into two halves. One
metabolism was investigated by testicular NO levels, half of each testicular sample was placed in Bouin’s
iNOS, and eNOS expressions. Testicular ischemic fixative solution for histological evaluation, and the
damage impairing spermatogenesis with the pos- other halves were snap-frozen in liquid nitrogen
sibility of leading to male infertility was assessed by and stored at -70ºC for biochemical evaluation.
germ-cell-specific apoptosis in the rat testis.

Assessment of Hormonal Function


Material and Methods of the Testes

Animals and Surgical Technique Serum samples were frozen at -70ºC for batch
analysis. Serum LH and FSH levels were assessed
The study comprised 40 male Swiss albino rats, by immunoradiometric assay methods with DPC
10–12 weeks old and 200–220 g in weight. The rats (Diagnostic Products, Los Angeles, CA, USA) re-

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Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis
59 8
agents. The method sensitivities were 0.15 mIU/ a terminal deoxynucleotidyl transferase-mediated
ml-1 and 0.06 mIU/ml-1. Intra-assay precisions biotin nick end–labeling (TUNEL) method. Frag-
were 1.6 and 7.1%, and interassay precisions were mentation of DNA in the nucleus is one of the first
3.8% and 5.7% for LH and FSH, respectively. morphological changes in the apoptotic process
and can be detected in histological sections us-
ing the TUNEL method performed with a com-
Concentration of NO in Testes mercial kit, such as the DeadEnd Colorimetric
TUNEL system (Promega G7130), according to
In estimating the tissue NO production, biochemi- the manufacturer’s instructions. The quantification
cal assessments of stable NO oxidative metabolite of apoptosis was carried out in a blind fashion by
(nitrite and nitrate) levels were analyzed. Assess- two independent observers.
ments of tissue nitrite and nitrate levels were based
on the Griess method. The absorbance of the re-
action mixture was measured at 545 nm with a Statistical Evaluation
spectrophotometer (Shimadzu, Japan). A standard
curve was obtained with concentrations of 2–10 Statistical analyses were performed with SPSS 10.0
mmol/l-1 sodium nitrate. Data in this study present software. Groups were compared using a two-
the total nitrite and nitrate, which are NO metabo- tailed Student’s t-test, one-way ANOVA test, and
lites and are expressed as mmol/g-1 wet tissue. Mann–Whitney U-test. Values of p<0.05 were con-
sidered to indicate statistical significance.

Immunohistochemical Evaluation
Results
All specimens were fixed in Bouin’s solution for
24 h. Sections (5 mm thick) from paraffin blocks Testicular tissue NO levels in ipsilateral and con-
were incubated in a solution of 3% H2O2 for 15 tralateral testes in the mesh-implanted group
min to inhibit endogenous peroxidase activity. and sham-operated control groups are shown in
Then sections were washed with phosphate base ⊡ Table 8.1. We found significant increases in the
solution (PBS) and incubated for 18 h at 4ºC with ipsilateral testicular NO level compared with the
primary antibodies: anti-iNOS at a 1/100 dilution contralateral NO level in the mesh-implanted
(Zymed 61-7700) and anti-eNOS at a 1/200 dilu- group and the control group (p=0.0001, p=0.002,
tion (Biomol SA-258). Afterwards, sections were respectively). Comparison of the mesh-implanted
washed three times for 5 min each with PBS, fol- group and the control group revealed significantly
lowed by incubation with biotinylated IgG and (p=0.015) higher NO levels in the ipsilateral mesh
then with streptavidin–peroxidase conjugate group.
(Dako). They were incubated with DAB (3.3’-di- The results of hormonal evaluation of testicu-
aminobenzidine) substrate for detection of im- lar function of the study groups preoperatively and
munoreactivity. Control samples were processed in 6 months postoperatively are given as mean ± stan-
an identical manner, but the primary antibody step dard deviation. Serum LH and FSH levels are sum-
was omitted. Staining intensity was graded as mild marized in ⊡ Table 8.2 for preoperative serum sam-
(+), moderate (++), or strong (+++). ples and 6-month postoperative serum samples in
the mesh-implanted group and the sham-operated
control group. No significant statistical differences
Detection of Apoptotic Cell Death between preoperative and postoperative samples
In Situ Using the TUNEL Method were seen in serum LH or FSH levels.
We found mild (+) eNOS activity in ipsilat-
To obtain evidence for induction of programmed eral and contralateral specimens of the mesh-im-
cell death, apoptotic cells were identified using planted and sham-operated groups. However, (+)
60 Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis Used for Inguinal Hernia Repair

⊡ Table 8.1. Testicular tissue nitric oxide (NO) levels in ipsilateral and contralateral testes in the mesh and sham-operated
control groups (values given as mean ± standard deviation)

NO (μmol-1 wet tissue) Ipsilateral testis Contralateral testis P


a
Mesh group 230.3±90.9 180.6±74.8 0.0001

Sham-operated control group 166.56±32.0a 140.88±29.3 0.002


a
P=0.015

⊡ Table 8.2. Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the preoperative and post-
operative periods in the mesh-implanted and sham-operated control groups (values given as mean ± standard deviation)

Mesh-implanted group Sham-operated control group

Preoperative Postoperative Preoperative Postoperative


-1)
LH (mIU/ml 0.582±0.065 0.571±0.084 0.626±0.086 0.636±0.088
-1)
FSH (mIU/ml 0.362±0.050 0.353±0.041 0.385±0.043 0.340±0.050
8

iNOS activity was observed only in the ipsilateral terior tension-free repair patients. There were no
testis of the mesh-implanted study group, and no statistically significant differences between the pre-
expression was detected in the remaining samples operative and postoperative spermiogram results
(⊡ Fig. 8.1). TUNEL (+) apoptotic germ cells were for either group. No statistically significant differ-
not detected in any of the samples. ence was found between the two groups in terms
of Doppler flow parameters (peak systolic velocity,
end diastolic velocity, resistive index, pulsatility
Discussion index) for preoperative, early, or late postopera-
tive periods. When Doppler flow parameters were
The major finding of the present study was that compared for group I, a statistically significant dif-
no apoptotic TUNEL (+) cells were present in ference was found between preoperative and early
the mesh-implanted study group. Therefore, we postoperative values. No statistically significant
believe that mesh implantation does not cause difference was found between preoperative and
secondary ischemic changes in testicular function late postoperative values. This was also true for
over the long term. early postoperative values versus late postopera-
It has been shown that acute graded reductions tive values. When Doppler flow parameters were
in testicular blood flow affect the early stages of compared for group II, a statistically significant
spermatogenesis, which may have a major impact difference was found between preoperative and
on sperm production [9]. early postoperative values. No statistically signifi-
In my study in 2003, we evaluated the long- cant difference was found between preoperative
term effect of mesh and its localization (i.e., an- and late postoperative values. This was also true
terior or posterior) on testicular perfusion and for early postoperative values versus late postop-
function in groin hernia patients. Testicular func- erative values. No statistically significant differ-
tion was evaluated with spermiograms and testicu- ence was observed between preoperative and late
lar perfusion with color Doppler ultrasonography. postoperative Doppler flow parameters, nor was a
Group I consisted of 30 posterior preperitoneal statistically significant difference seen between the
mesh repair patients, and group II consisted of an- preoperative and day-75 postoperative spermio-

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Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis
61 8
Ipsilateral Contralateral

Mesh Mesh

Control Control

⊡ Fig. 8.1. Mild positive (+) iNOS immunostaining is shown in the contralateral (b) testis of the mesh-implanted study group
the stroma of the ipsilateral testis (a) of the mesh-implanted and ipsilateral (c) and contralateral (d) testes of the sham-
study group. Negative (-) iNOS immunostaining is shown in operated control group. ×400 original magnifications

gram results for either mesh repair group. Bear- tion, NO has a dual effect. On the one hand, it is
ing in mind the experimentally proven chronic vasodilatory in modest increases and potentially
inflammatory tissue reaction against mesh, these protective of testicular tissue, but on the other
results indicate that chronic tissue inflammation hand, excessive amounts can exert cytotoxic ef-
has no adverse effect on testicular perfusion or fects in combination with other cytokines and may
spermatogenetic function over time [10]. result in testicular germ-cell-specific apoptosis. In
The production of NO as well as its injuri- the present study, we observed a significant in-
ous metabolite peroxynitrite and other reactive crease in NO level and mild (+) iNOS expression
nitrogen species may result in a cascade of events in the ipsilateral side of the mesh-implanted group,
leading to DNA fragmentation and apoptosis. It is which suggests ischemic/inflammatory injury of
well known that the early stages of spermatogen- the mesh-implanted testis; however, this injury
esis are very sensitive to a moderate, acute reduc- was not sufficient to cause germ cell apoptosis in
tion in blood flow, and consistent reductions in the testicular tissue.
blood flow may interfere with sperm production In a study investigating the eNOS immunos-
and adversely affect fertility [11]. NO is one of taining and apoptosis in testicular ischemia, it
many inflammatory mediators, which include the was reported that acute (3 h) testicular ischemia
adhesion molecules and cytokines that contribute resulted in germ cell apoptosis, and strong eNOS
to the inflammatory cell adherence of testicular immunostaining was detected in the cytoplasm of
microvascular endothelium and lead to microcir- degenerating germ cells [13]. The authors suggest
culatory failure. Apoptosis is directly linked to the that strong eNOS immunostaining is associated
recruitment of neutrophils to subtunical venules with germ cell apoptosis. Similarly, in our observa-
[11]. NO is important in increasing blood flow and tions in the present study, the long-term results
inhibiting leukocyte accumulation [12]. In addi- of mesh implantation revealed mild (+) eNOS
62 Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis Used for Inguinal Hernia Repair

expressions in all samples, and no apoptotic germ 7. Bonfoco E, Krainc D, Ankarcrona M, Nicotera P, Lipton
cells were observed in testicular tissue. SA (1995) Apoptosis and necrosis: two distinct events
induced, respectively, by mild and intense insults with N-
In the present study we found no statistical
methy-D-aspartate or nitric oxide/superoxide in cortical
difference in serum hormone levels between the cell cultures. Proc Natl Acad Sci USA 92:7162–7166
mesh-implanted study groups and the sham-oper- 8. Taneli F, Aydede H, Vatansever S, Ulman C, Arı Z, Uyanık
ated controls. Thus, long-term mesh implantation BS (2005) The long-term effect of mesh bioprosthesis
does not cause biochemical alteration of the hor- in inguinal hernia repair on testicular nitric oxide meta-
bolism and apoptosis in rat testis. Cell Biochem Funct
monal functions of the testes.
23:213–220
Part of this study was presented at the 13th 9. Berg A, Collin O, Lissbrant E (2001) Effect of acute graded
European Microscopy Congress in 2004. Our pre- reduction in testicular blood flow on testicular morpho-
sented results demonstrated that cells with py- logy in the adult rat. Biol Reprod 64:13–20
knotic nuclei, which indicate apoptotic cells, were 10. Aydede H, Erhan Y, Sakarya A, Kara E, Iklgül O, Can M
(2003) Effect of mesh and its localisation on testicular flow
observed less in the mesh group than in the con-
and spermatogenesis in patients with groin hernia. Acta
trol group when analyzed both by light and elec- Chir Belg 103:607–610
tron microscopy [14]. 11. Lysiak JJ, Turner SD, Nguyen QAT, Singbarth K, Ley K,
In conclusion, using prosthetic mesh in hu- Turner TT (2001) Essential role of neutrophils in germ
mans did not cause any defects in testicular perfu- cell-specific apoptosis following ischemia/reperfusion of
mouse testis. Biol Reprod 65:718–725
sion or spermatogenetic function. In this experi-
8 mental model, NO level as an oxidative damage
12. Lissbrant E, Lofmark U, Collin O, Berg A (1997) Is nitric
oxide involved in the regulation of rat testicular vascula-
indicator was found to be increased in rat testes, ture? Biol Reprod 56:1221–1227
and iNOS overexpression was detected immuno- 13. Zini A, Abitbol J, Girardi SK, Schulsinger D, Goldstein M,
histochemically. The increased level of NO is one Schegel PN (1998) Germ cell apoptosis and endothelial ni-
tric oxide synthase (eNOS) expression following ischemia-
of the apoptotic promoters. However, finding no
reperfusion injury to testis. Arch Androl 41:57–65
difference for apoptosis and no ultrastructural dif- 14. Vatansever HS, Taneli F, Kayma F, Köse CF, Müftüoğlu S,
ference in electron microscopy emphasizes that İlgül O (2004) Testicular nitric oxide levels and apoptosis
this oxidative damage is compensated for by tes- in rat testes during inguinal hernia repair after using
ticular tissue. Thus, prosthetic mesh repair in pa- long-term mesh bioprosthesis. In: Proceedings of the13th
European Microscopy Congress, Antwerp, Belgium, 22–27
tients undergoing infertility treatment can be me-
August 2004
ticulously reevaluated.

References Discussion

1. DeBorg JR (1998) The historical development of prosthe- Schumpelick: I looked for your spermiograms.
tics in hernia surgery. Surg Clin North Am 78:973–1006
Did you see any differences in motility or in any
2. Klinge U, Klosterhalfen B, Müller M, Schumpelick V (1999)
Foreign body reaction to meshes used for the repair of
other analysis of testicular function besides the
abdominal wall hernias. Eur J Surg 165:665–673 spermiograms according to the investigation pe-
3. Bendavid R (1998) Complications of groin hernia surgery. riod?
Surg Clin North Am 78:1080–1103 Aydede: You are right. In our study we found no
4. Moncada S, Palmer RMJ, Higgs EA (1991) Nitric oxide: phy-
statistical significant difference between the differ-
siology, pathophysiology and pharmacology. Pharmacol
Rev 43:109–142
ent investigation time points.
5. Zini A, O’Bryan MK, Magid MS, Schlegel PN (1996) Immu- Klinge: The point I want to address is the method
nohistochemical localisation of endothelial nitric oxide of statistical analysis. You frequently said that some
synthase in human testis, epididymis and vas deferens differences were statistically significant or not sig-
suggest a possible role for nitric oxide in spermatogene-
nificant. I’m not sure whether many of these data
sis, sperm maturation and programmed cell death. Biol
Reprod 55:935–941
were really normal distributed. If you compare
6. Nathan C (1997) Inducible nitric oxide synthase: what just the means between two groups, I’m not sure
differences does it make? J Clin Invest 100:2417–2423 if some single details, such as a complete constric-

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Chapter 8 · The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis
63 8
tion of the vas, will be detected by this test. Did
you use some other statistical tests for subgroups
in your entire cohort?
Aydede: At this time I can’t give you more infor-
mation about statistical analysis than the Mann–
Whitney U-test. We should do a more detailed
analysis.
Gryska: In the very first clinical study, how many
patients did you have in each group?
Aydede: We had about 30 patients in each group.
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9

Reoperation Following Lichtenstein


Repair: What Do Vas and Nerves Look
Like?
U. Muschaweck
66 Chapter 9 · Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like?

Introduction

Lichtenstein repair is recommended in national


guidelines as the first choice for uncomplicated
primary inguinal hernia. It is known as easy to
perform, has a short learning curve, and is said
to have the smallest risk for recurrent hernia and
other complications.
However, in the year 2007 we had to reoperate
on 232 patients with recurrent hernia, making up
20% of all our operations. Of these, 31 had had a
previous Lichtenstein repair. In all 31 cases, the
intraoperative findings showed complete incorpo-
ration of at least one nerve, mesh shrinkage and
migration, and excessive scar tissue in the area of ⊡ Fig. 9.1. Case 1: hardened mesh with stiff, sharp edges; vas
adherent to mesh edge
the external oblique fascia, the internal oblique
muscle, and the groin ligament. We always had to
remove the mesh completely because of the tissue
damage in the groin canal. Also, neurectomy of at
least one nerve always had to be done.
9
Case Reports

We have selected six cases of patients with se-


vere chronic groin pain resulting in reoperation
with impressive intraoperative findings. Two of
these had a severed vas that was caused by the
mesh.

⊡ Fig. 9.2. Case 1: ilioinguinal nerve thickened; surface rough,


Case 1: DL, 62-Year-Old Man from not shiny; surrounded by fibrotic tissue. Recurrent hernia
Wales 3×3 cm

History: Lichtenstein repair in Cardiff, Wales, in


October 2006. After 1 year, massive pain in the
groin and radiating, burning pain to the scrotal
area and penis. Unable to walk more than 30 m.

Applied surgical technique: Removal of the


mesh, neurectomy of the ilioinguinal nerve, Lich-
tenstein repair with UltraPro mesh (⊡ Figs. 9.1 and
9.2). Patient immediately free of pain.

Electron microscopy and histological findings:


Heavyweight small-pore polypropylene mesh; in- ⊡ Fig. 9.3. Case 1: heavyweight small-pore polypropylene
growth of nerve with marked perineural fibrosis; mesh; ingrowth of nerve with marked perineural fibrosis;
posttraumatic neuroma (⊡ Fig. 9.3). posttraumatic neuroma

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Chapter 9 · Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like?
67 9
Case 2: HB, 61-Year-Old Man from Electron microscopy and histological findings:
Germany Large-pore polypropylene mesh (⊡ Fig. 9.6), mod-
erate foreign body reaction (epithelioid cell type).
History: Lichtenstein repair in Oldenburg, Ger-
many, in October 2006. After 8 months, new bulge
was present, with pressure and pain in the groin Case 3: MR, 26-Year-Old Man from
and severe pain during ejaculation. Denmark

Intraoperative findings: Excessive scar tissue; mesh History: Lichtenstein repair in September 2007,
surrounding vas at the internal ring (⊡ Figs. 9.4 and with pain starting immediately afterward. Reop-
9.5). eration in December 2007.

Applied surgical technique: Removal of the mesh, Intraoperative findings: Mesh covering the ilio-
neurectomy of the ilioinguinal nerve, minimal repair inguinal nerve completely; nerve partly growing
(suture repair). Patient immediately free of pain. into the mesh (⊡ Fig. 9.7).

⊡ Fig. 9.4. Case 2: excessive scar tissue; mesh surrounds vas at ⊡ Fig. 9.6. Case 2: large-pore polypropylene mesh, moderate
the internal ring foreign body reaction (epithelioid cell type)

⊡ Fig. 9.5. Case 2: ilioinguinal nerve thickened and grown into ⊡ Fig. 9.7. Case 3: mesh covers the ilioinguinal nerve com-
the upper edge of the mesh, surrounded by fibrotic tissue; pletely; nerve partly growing into the mesh; small medial
lateral recurrent hernia 8×2 cm recurrent hernia
68 Chapter 9 · Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like?

⊡ Fig. 9.8. Case 3: heavyweight small-pore polypropylene ⊡ Fig. 9.9. Case 4: inguinal nerve ingrowth into mesh; lateral
mesh, foreign body granuloma, perineural fibrosis edge of mesh rolled up and penetrating through the fascia and
subcutaneous tissue; palpable through skin. No recurrent hernia

Applied surgical technique: Removal of the mesh


9 with neurectomy and minimal repair.

Electron microscopy and histological findings:


Heavyweight small-pore polypropylene mesh
(⊡ Fig. 9.8), foreign body granuloma, perineural
fibrosis. Low-grade infection with neutrophilic
granulocytes.

Case 4: GM, 40-Year-Old Man from Italy

History: Lichtenstein repair in 2005, with pain


starting immediately afterward. Reoperation in
February 2008.
⊡ Fig. 9.10. Case 4: double-layered, heavyweight, small-pore
Intraoperative findings: Inguinal nerve ingrowth polypropylene mesh
into mesh; lateral edge of mesh rolled up and
penetrating through the fascia and subcutaneous
tissue; palpable through the skin (⊡ Fig. 9.9). No
recurrent hernia. Case 5: JC, 66-Year-Old Man from England

Applied surgical technique: Removal of the mesh History: Lichtenstein repair in 2001, reoperation
with only a neurectomy done. in 2008.

Electron microscopy and histological findings: Intraoperative findings: Mesh corrugated, only
Double-layered, heavyweight, small-pore polypro- partial ingrowth (⊡ Fig. 9.11). Ilioinguinal nerve
pylene mesh, bulky board of scar, beginnings of adherent to mesh over 2 cm. Lateral recurrent her-
calcification (⊡ Fig. 9.10). nia 3×2 cm.

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Chapter 9 · Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like?
69 9

⊡ Fig. 9.11. Case 5: mesh corrugated; only partial ingrowth. ⊡ Fig. 9.12. Case 5: mesh type uncertain, chronic inflamma-
Ilioinguinal nerve adherent to mesh over 2 cm. Lateral recur- tion (giant cells)
rent hernia 3×2 cm

Applied surgical technique: Removal of the


mesh, neurectomy, Lichtenstein repair with Ultra-
Pro mesh.

Electron microscopy and histological findings:


Mesh type uncertain (⊡ Fig. 9.12), chronic inflam-
mation (giant cells).

Case 6: HW, 29-Year-Old Woman from


Germany

History: Lichtenstein repair in March 2006. Pain ⊡ Fig. 9.13. Case 6: Vypro mesh with ingrowth of ilioinguinal
started in August 2007; reoperation in February nerve. Medial recurrent hernia 3×2.5 cm
2008.

Intraoperative findings: Small amount of Vy-


pro mesh with ingrowth of ilioinguinal nerve
(⊡ Fig. 9.13). Medial recurrent hernia 3×2.5 cm.

Applied surgical technique: Removal of the mesh


(⊡ Fig. 9.14), followed by neurectomy and minimal
repair.

Electron microscopy and histological findings:


Vypro mesh with posttraumatic neuroma and
marked perineural fibrosis.

⊡ Fig. 9.14. Case 6: removal of the mesh, followed by neurec-


tomy and minimal repair
70 Chapter 9 · Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like?

Is the Mesh Type Important? most cases there is only one nerve left. So I prefer
resecting the mesh and the mesh in this case.
This sample of six patients whom we looked at Uzzo: In the literature you find up to a 10%
in greater detail is certainly very small. But there chronic pain rate after Lichtenstein repair. I think
is only a slight tendency that heavyweight mesh we should stop saying that Lichtenstein repair is
might be more often involved (see ⊡ Table 9.1). easy to perform. You said it during your slides.
Obviously, it’s not easy.
Muschawek: You are right. It looks easy, but there
Summary are many details you have to think about.
Heniford: I think we should put all these problem
In these six patients, heavyweight small-pore patients together with a standard study protocol,
meshes were slightly more predominant than and we will get very quickly large numbers of pa-
heavyweight large-pore or lightweight meshes. But tients through which we can answer questions.
more important than the choice of mesh is the Klinge: You have a lot of experience with recurrent
surgical handling of the nerve. (Is a primary resec- hernias. Do you think that it makes a difference in
tion better than keeping the nerve?) Therefore, the reoperating after 2 years or after 10 years?
indication for mesh repair must be carefully con- Muschawek: No. You will have the adhesion within
sidered, particularly in young patients. a few weeks after operation.
Kehlet: I just remember the first reports about
pain after Lichtenstein repair. Now we are sitting
9 ⊡ Table 9.1. Mesh types encountered in the six cases
here for a full meeting discussing chronic pain. So
and examined by electron microscopy I think we have to be careful also with this fertility
problem. We have to look at it, and we cannot say
Polypropylene 4 it is probably not a real problem.
Heavyweight small-pore 3

Heavyweight large-pore 1

Vypro 1

Unknown (could not be analyzed) 1

Discussion

Schumpelick: You mentioned that the nerve has


grown into the mesh, but it may be that the mesh
has grown into the nerve.
Muschawek: You are right; during the explantation
you are not able to see which direction was the
right one.
Miserez: Two questions on the six patients you
operated on for pain and recurrence. First, is it
enough to do a single neurectomy, and second, do
we need to remove the mesh for pain?
Muschawek: I’m sure, because the mesh always
covers the nerve, and if you lift up the mesh you
can see the nerve going into the mesh. And in

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10

Damage to the Spermatic Cord


from Groin Herniorrhaphy: A Review
R. C. Read
72 Chapter 10 · Damage to the Spermatic Cord from Groin Herniorrhaphy: A Review

Introduction of the pubic tubercle. Division of the peritoneal


sac there allows for reduction and inversion of its
Complications following repair of inguinal hernia- proximal portion into the preperitoneal space. In
tion have historically been attributed to poor surgi- cases of recurrent herniation, a posterior prep-
cal technique and blamed on inexperience. Those eritoneal approach to repair should be employed,
related to the spermatic cord, testicular atrophy thereby avoiding dissection of a scarred spermatic
and occlusion of the vas deferens, are dreaded cord. Adopting these ideas for his next group of
because the patient, angry that his manhood has 4,000 Shouldice hernioplasties resulted in only one
been threatened, often resorts to litigation. Isch- case of ischemic orchitis.
emia of the testicle was said to be the result of a In 1983, Bendavid encountered a patient who
too-tight reconstruction of the internal inguinal complained of episodes of brief, severe pain in the
ring [1]. Injury to the vas deferens is presumed to groin during ejaculation. He had previously been
arise after harsh separation of the hernial sac. The operated on using the Shouldice procedure. By
former may be ligated, divided, or devascularized. 1991, another 16 cases had been identified, two
Considered rare, it is underreported because most of whom had not received surgery but suffered
men undergoing groin repair tend to be older and from chronic epididymitis or cancer of the prostate
are no longer concerned about their reproduc- treated with radiotherapy. The next year, Benda-
tive capacity. Because most inguinal herniae are vid labeled this new syndrome »dysejaculation«
unilateral, younger men rarely face sterility. Nev- [4]. Another 13 cases were reported in 1995 [5].
ertheless, a significant minority have bilateral re- Symptomatology began 1 month to 2 years postop-
pairs. Further, cryptorchidism or later epididymitis eratively. Reoperation showed either separation of
can eliminate the spermatic contribution from the the vas deferens from its blood supply, adherence
contralateral groin. to the transversalis fascial floor of the inguinal
10 canal, kinking, abrasions, stricture, or scarring.
Bendavid considered that the mechanism for pain
Sutured Repair was retrograde distension of a blocked vas defer-
ens, since ejaculation begins with peristalsis in the
During the latter half of the 20th century, the epididymis, passing down to the seminal vesicles
Shouldice–Bassini procedure became the gold and prostate. Delay in onset postoperatively in-
standard for groin hernioplasty. In the early 1980s, dicated scarring secondary to the dissection that
Wantz and Bendavid, two pioneers in herniology, had been required to remove both the cremasteric
separately focused attention on testicular ischemia musculature and the hernial sac. Because some of
and vasal narrowing. In 1982, Wantz [2, 3] re- Bendavid’s patients became pain free over time,
ported that 11 of 1,682 patients developed orchitis conservative treatment was recommended.
within a week. All had had complete removal of
their scrotal sacs. After the same operation was
performed on 311 men for recurrence, seven pro- Prosthetic Repair [6]
gressed to testicular atrophy. Wantz blamed dissec-
tion through scarred tissue. The common feature Reinforcement of sutured hernioplasties began in
was thrombosis affecting the pampiniform plexus the last decade of the 19th century, a few years after
and leading to venous infarction. Wantz pointed Bassini’s cure became well known. In 1894, Phelps
out that constriction at the internal inguinal ring employed silver coils. Later, filigrees of other met-
was not responsible because ligation of testicular als were used. However, rigidity, fibrosis, sinuses,
veins at this level, which is standard treatment for radiopacity, and both patient and surgeon discom-
varicocele, does not cause testicular infarction. To fort discouraged their use. In 1944, Aquaviva and
avoid this complication, he recommended that in a Bounet introduced Nylon mesh. Their prosthetic
complete indirect inguinal hernia, dissection of the design remains, but polypropylene, which was first
hernial sac should not proceed beyond the level used by Usher in 1963, is now the most popular

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Chapter 10 · Damage to the Spermatic Cord from Groin Herniorrhaphy: A Review
73 10
mesh. Nevertheless, it was not until the final de- polypropylene mesh on the spermatic cords of
cade of the 20th century that a majority of groin rats 3 months after Lichtenstein repair, using the
repairs became prosthetic and the Lichtenstein Shouldice procedure as control. Interestingly, they
procedure was the new gold standard. This change found impaired testosterone production and nar-
resulted from a significant reduction in the rate of rowing of the vas deferens only with low-weight
recurrent herniation. composite mesh. There was no difference in the
LeBlanc et al. [7], using endoscopy, placed inflammation or fibrosis evoked by the different
mesh preperitoneally overlying the internal ingui- meshes, contrary to results from previous studies
nal ring of pigs. Examples of venous congestion [16, 17].
in the pampiniform plexus were found, indicat- Dilek et al. [18] measured testicular blood flow
ing that the posterior preperitoneal approach to before and 3 months after patients were randomly
the groin does not preclude venous infarction of assigned to laparoscopic or Lichtenstein repair of
the testicle. In 1999, Uzzo et al. [8] claimed to be inguinal herniation. Neither technique affected tes-
the first to examine the effects of mesh-induced ticular blood flow. Taneli et al. [19] studied testicu-
fibrosis on components of the spermatic cord. Us- lar metabolism in rats whose spermatic cord was
ing dogs, unilateral inguinal defects were created exposed to a layer of polypropylene mesh. Find-
and repaired using either polypropylene mesh or ings were compared to those for sham-operated
the Shouldice technique. The contralateral groin controls 6 months later. There was no significant
served as a control. A year later, autopsies revealed difference in serum hormone levels or apoptosis
patent but significantly narrowed vasa deferentia in the testes. Their results support the 2001 results
in both repair groups. Hydroceles and testicular of Zieren et al. [10] and Taylor et al. [9]. Shin et al.
atrophy were found in half of the dogs treated with [20] presented their multi-institutional experience
mesh; none followed sutured repair. Taylor et al. of 14 younger men previously repaired for inguinal
[9] studied patients who had undergone repair of herniae, mainly using the Lichtenstein procedure,
unilateral inguinal herniation with either the lap- who reported infertility. Nine had bilateral vasal
aroscopic or anterior prosthetic (polypropylene) obstruction, and five had unilateral obstruction
technique 3 years previously. There was no signifi- with contralateral testicular atrophy or epididymi-
cant effect on testicular blood flow. tis. The mechanism was dense fibrosis. All had
Zieren et al. [10] reported in 2001 that tes- normal blood hormone levels. The authors point
ticular perfusion remained unchanged 6 months out that the vasal narrowing described by Uzzo et
after patients received plug-and-patch repairs for al. [8] at 1 year postoperatively could, over time,
inguinal herniation. Aydede et al. [11] obtained become an occlusion. Iatrogenic injury to the vas
similar results, long term, after randomly assigning deferens such as ligation, cauterization, incision, or
patients to anterior or preperitoneal prosthetic re- vascular compromise could also be a factor.
pair. Laparoscopic mesh repair of inguinal herniae Goldenberg and de Paula [21] studied the
was found to result in dysejaculation that began an 2-month effect of simulated polypropylene mesh
average of 3 months postoperatively in 10% [12] repair in the groin of dogs. Observations were
or 3.9% [13] of patients. Thus, as with damage compared with contralateral dissected or unoper-
to the pampiniform plexus, the preperitoneal ap- ated controls. The inflammatory response–100%
proach does not confer exemption from injury to with mesh, 71% without–involved the vas deferens
the vas deferens. Its incidence appears to increase in all subjects in the mesh group, causing statisti-
with the use of mesh. Silich and McSherry [14] cally significant narrowing. A third of the animals
reported a patient with a sperm granuloma 4 years that received mesh showed congestion of the pam-
after a Lichtenstein repair. They believe it arose piniform plexus. Peiper et al. [22] experimented
from erosion of the vas deferens by the cut edge on pigs and rabbits to determine whether a risk
of the mesh at the medial end of the slit made to of infertility exists after inguinal mesh repair. In
recreate the internal inguinal ring. Berndsen et al. the former, transinguinal preperitoneal repair with
[15] compared the effects of heavy or lightweight polypropylene mesh, after resection of the cre-
74 Chapter 10 · Damage to the Spermatic Cord from Groin Herniorrhaphy: A Review

master, was compared to a contralateral Shouldice tured repair (Shouldice). The risk to the spermatic
procedure. Within a month, one-third of those cord increases after its isolation by excision of the
receiving mesh demonstrated venous thrombosis cremaster muscle and scrotal sacs. Reoperation
in the pampiniform plexus even though the sper- requiring dissection through scar tissue jeopar-
matic cord was exposed to the prosthesis only at dizes the cord, and tissue reaction to prostheses
the internal inguinal ring. The rabbits underwent augments damage to cord structures. Lightweight
unilateral Lichtenstein repair with preservation of mesh cannot be relied upon to evoke less fibrosis
the cremaster muscle, and contralateral Shouldice than heavyweight mesh. Spermatic cord complica-
repair was also undertaken. Testicular parameters tions are not avoided by preperitoneal placement
were compared with those of unoperated con- of prostheses. Pathology, secondary to groin dis-
trols. Each repair reduced perfusion, more so with section and the use of mesh, has been shown to af-
Lichtenstein. Kolbe and Lechner [23] wrapped the fect the vas deferens more often than the pampini-
vasa deferentia of rats with either heavyweight or form plexus. Arterial flow to the testis is affected
lightweight polypropylene mesh. After 3 months, little by prosthetic repair unless, in a minority,
their fertility was determined by mating them and venous thrombosis supervenes. Vasal occlusion is
counting the oocytes or embryos. Some sperm underreported since most inguinal herniorrhapies
granulomas were observed in the heavyweight are performed on the elderly, who usually are not
mesh group, but neither prosthesis reduced fer- concerned about fertility. In younger men, sterility
tility compared with controls, which had simply is generally not a problem because most repairs
undergone isolation of the vas deferens. Interest- are unilateral. However, contralateral diseases or
ingly, both meshes induced a similar inflammatory bilateral hernioplasties can result in sterility. It
reaction, supporting the work of Berndsen et al. has been reported that subcutaneous placement of
[15] but not that of others [16, 17]. the spermatic cord in men after bilateral Lichten-
10 Witkowski and Trabucco [24] questioned the stein repair, as recommended by Witkowski and
reported increased risk of vas deferens occlusion Trabucco, significantly improves fertility compared
after mesh inguinal hernioplasty. They cite Fitzgib- with the classic Lichtenstein procedure.
bons [25], who has argued that »no correlation
between fibrosis and vasal obstruction has been
proven.« Witkowski and Trabucco [24] stated, as References
did Shin et al. [20], that it is therefore possible that
intraoperative damage from dissection or fixation 1. Koontz AR (1965) Atrophy of the testicle as a surgical risk.
is responsible. Regardless, they suggest separat- Surg Gynecol Obstet 120:511–513
ing the mesh from the spermatic cord by placing 2. Wantz GE (1982) Testicular atrophy as a risk of inguinal
it subcutaneously à la Halsted–Bassini. In 2008 hernioplasty. Surg Gynecol Obstet 154:570–571
3. Fong Y, Wantz GE (1992) Prevention of ischemic orchi-
Gventatadze [26] tested the effect of such isola- tis during inguinal hernioplasty. Surg Gynecol Obstet
tion on sperm morphology in patients undergoing 174:399–402
the modified bilateral Lichtenstein repair. Com- 4. Bendavid R (1992) »Dysejaculation«: an unusual com-
parison was made with others receiving the classic plication of inguinal herniorrhaphy. Postgrad Gen Surg
procedure. A statistically significant deterioration 4(2):139–141
5. Bendavid R (1995) Dysejaculation. Probl Gen Surg
(p<0.01) in sperm parameters was found in the
12(2):237–238
latter. 6. Read RC (2004) Milestones in the history of hernia sur-
gery: prosthetic repair. Hernia 8:8–14
7. LeBlanc KA, Booth WV, Whitaker JM et al. (1998) In vivo study
Conclusions of meshes implanted over the inguinal ring and external
iliac vessels in uncastrated pigs. Surg Endosc 12:247–251
8. Uzzo RG, Lemack GE, Morrissey KP et al. (1999) The effects
In summary, venous infarction of the testicle (at- of mesh bioprosthesis on the spermatic cord structures: a
rophy) and narrowing of the vas deferens (dys- preliminary report in a canine model. J Urol 161(4):1344–
ejaculation) were rarely reported following su- 1349

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hernia repair. World J Surg 26:1472–1480
18. Dilek ON, Yucel A, Akbulut G et al. (2005) Are there ad-
verse effects of herniorrhaphy techniques on testicular
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19. Taneli F, Aydede H, Vatansever S et al. (2005) The long-
term effect of mesh bioprosthesis in inguinal hernia repair
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testis. Cell Biochem Funct 23:213–220
20. Shin D, Lipshultz LI, Goldstein M et al. (2005) Herniorrha-
phy with polypropylene mesh causing inguinal vasal obs-
truction. A preventable cause of obstructive azoospermia.
Ann Surg 241(4):553–558
21. Goldenberg A, de Paula JF (2005) Effects of polypropylene
mesh implanted through inguinotomy on the spermatic
funiculus, epididymis and testis of dogs. Acta Cir Bras
20(6):461–467
22. Peiper C, Junge K, Klinge U et al. (2006) Is there a risk of
infertility after inguinal mesh repair? Experimental studies
in the pig and rabbit. Hernia 10(1):7–12
23. Kolbe T, Lechner W (2007) Influence of hernioplastic im-
plants on male fertility in rats. J Biomed Mater Res B Appl
Biomater 81B:435–440
24. Witkowski P, Trabucco EE (2007) Is there an increased
risk of vas deferens occlusion after mesh inguinal her-
nioplasty and what we can do about it? [letter] Ann Surg
245(1):153–154
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II

II Risk for Infection

11 Mesh Infection Following Hernia Repair:


A Frequent Problem? – 79

12 Patient Factors as a Major Determinant of Wound Outcome


and Infection After Surgery – 87

13 Mesh-Related Infections After Hernia Repair – 97

14 Human Acellular Dermal Matrix for Ventral Hernia Repair


in the Compromised Surgical Field – 103

15 Fate of the Inguinal Hernia Following Removal


of Infected Prosthetic Mesh – 113

16 Mesh Infection–Therapeutic Options – 119

17 Does Antibiotic Prophylaxis Prevent the Occurrence


of Wound Infection After Groin Hernia Surgery? – 125

18 Infection Control in a Hernia Clinic: 24-Year Results


of Aseptic and Antiseptic Measure Implementation
in 4,620 »Clean Cases« Based on Up-To-Date
Microbiological Research – 135

19 Components Separation Technique: Pros and Cons – 143


[UnitedVRG] - Medical Release Group
11

Mesh Infection Following Hernia


Repair: A Frequent Problem?
B. J. Lammers, A. Baer, T. Sauer, P. Pohl, P. E. Goretzki
80 Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?

Introduction Looking through the literature, no definitions


of mesh infection are available. But at the very
Wound and mesh infections after hernia repair are least, there is a risk of infection of the mesh with
very severe complications. On the one hand, today any kind of wound infection, so we should be alert
it is well established to repair hernias with meshes for signs of deep infection, including the mesh
in very different ways, but on the other hand, (onlay, intraperitoneal onlay, sublay, etc.):
knowledge of the incidence of severe infections, ▬ Fever
including mesh infection, is quite rare [1, 2]. ▬ Signs of infection (swelling, oedema)
In this chapter we aim to define which kinds ▬ C-reactive protein and leucocytosis
of infections we can recognise. The rate of infec- ▬ Contaminated mesh
tion after mesh repair differs, of course, between
inguinal hernia repair and incisional hernia repair. Inguinal hernia surgery is primarily sterile sur-
In the United States it is very common to use the gery with low contamination. In abdominal wall
group of ventral hernias of the abdominal wall (in- surgery, the infection rate is higher, so it must be
cluding incisional, epigastric, Spigelian, and um- regarded as contaminated surgery.
bilical hernias).
According to the infection, we will look at
infections in this group as well as in inguinal her- Materials and Methods
nias, including femoral hernias. Therefore, we will
address just two groups: ventral hernias (laparo- We did a literature review of papers involving
scopic and open) and inguinal hernias (open and more than 100 patients with ventral hernia repair
laparoscopic procedures). and incisional hernia repair, and we also included
Using new techniques and new materials, it is our own data. The main topic of this investigation
impossible to define detailed risk factors for wound was the rate of infections, including mesh-related
and mesh infection that are related to each proce- infections, if these data were available. However,
11 dure and each material. The literature includes many papers lacked information on this problem.
some references on this; these will be remarked The group of inguinal hernia repairs was cov-
upon in this chapter regarding some special top- ered by an overview of inguinal hernia repair in
ics. Further investigations are necessary, and the the North Rhine region of Germany for a period of
authors of other chapters will also comment on 10 years with almost 200,000 operations [3]. This
this topic. period included the development of a reporting
system and the new video-assisted technologies
(transabdominal preperitoneal and totally extra-
Definition of Surgical Site Infection peritoneal repair). There are very few papers on
mesh infection in inguinal hernia repair. Fistula
Using the definition of the Centers for Disease formation is also very rare, so this was not dis-
Control and Prevention, infections are divided into cussed in this overview. Obviously, the problem in
superficial and deep infections. Superficial infec- inguinal hernia repair nowadays is not evident.
tion occurs in the first 30 days after an interven-
tion, and deep infection occurs within 1 year and
involves the fascia, the muscle layers, and the graft. Results
We must recognise that there are early infec-
tions within the first 30 days after implantation Ventral Hernias and Incisional Hernia
and late infections that may occur years after im- Repairs Without Mesh Repair
plantation. Furthermore, we may encounter fur-
ther intraabdominal problems, such as abscess for- This operation, which is done in many countries
mation, bowel injury, peritonitis, and so on, with using direct suture or doubling of the fascia (called
both early and late onset. the Mayo repair in Germany), is not standard

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Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?
81 11
therapy today because mesh repair is accepted. might be the evolution of new meshes. Ramshaw
However, many patients need a nonmesh repair. et al. [13] and Stoppa [14] have had very high rates
The infection rate with antibiotic prophylaxis is of wound infections, 15–25% (⊡ Table 11.1). In the
about 6–10 % [4–6]. Our own experiences with a last years, open mesh repairs have usually been
long-term run of 20 years show an infection rate associated with a lower rate of wound infections,
of 12%, including complete wound rupture. These 0.6–7% [4, 15–17]. But the main topic of these
data show the general problem of incisional hernia papers is usually not the infection rate.
repair: contaminated surgery. The rate of postop- Mesh infections and the rate of mesh removal
erative infections is over 10%. The bacteria stay in must be mentioned, although this topic is difficult
the wound for a long time. to discuss because data on this are not available
in every study. Finan et al. [16] found some risk
factors for infection: immunosuppression, smok-
Incisional Hernias with Mesh Repair ing, intraoperative bowel injury, bowel resection
emergency procedures, complicated hernia surgery
We analysed the publications involving more than (incarcerated, obstructed, or strangulated), and op-
100 patients. Many of them are multicentre stud- erating time. The variation in rates among different
ies; there is just one randomised multicenter study, hospitals reported in this paper is very interesting–
from Conze [7]. Leber et al. showed in a retrospec- from 1% to 9%. The mesh infection rate was be-
tive study in 1998 that in open mesh repair, many tween 0.3% and 6%. So the rate of mesh infection
early and late postoperative problems occur. Par- differed, and not every infected mesh was removed,
ticularly significant was the high rate of infections but the data on this problem are very sparse [16].
and fistulas [1]. They showed that at that time it
was not clear which positions of the meshes related
to the material were possible. The infection rate Tailored Incisional Hernia Surgery –
reported in the older papers is higher than in the Our Results
papers published in the last 3 years [8–12]. Obvi-
ously, surgeons are gaining experience and are able In our experience since 1996 of using a tailored
to manage the problems better. Another possibility concept for all operations with mesh (494 of 798),

⊡ Table 11.1. Literature overview of mesh infections in open incisional hernia treatment (minimum 100 cases)

First author Year N Wound infections (%) Mesh infections (%) Mesh removal (%)

Iannitti [15] 2008 455 0.3 0.3 ?

Lammers [17] 2008 774 7 2 0.5

Israelsson [4] 2006 349 9.6

Mahmoud Uslu [18] 2006 291 3.3 0.6

Finan [16] 2005 1505 5 ? ?

Conze [7] 2005 165 17.8 -

Basoglu [32] 2004 264 21.5 2 fistulas

McGreevy [9] 2003 71 8.4 2

Korenkov [30] 2002 160 13

Ramshaw [13] 1999 174 15.5 6 6

Stoppa [14] 1989 368 15 ß


82 Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?

we have had a general wound infection rate of difference between composite and regular meshes.
8.9%. For intraperitoneal onlay mesh (IPOM) re- All patients had sublay repair (⊡ Table 11.1).
pair (222 operations), we have had a mesh infec-
tion rate of 4%, and only 2.3% of the meshes were
removed (only expanded polytetrafluoroethylene, Wound and Mesh Infections
or ePTFE, meshes must be removed). In the onlay in Laparoscopic Hernia Repair
repair group (223 operations), we have had a 2.2%
mesh infection rate, and just one of 223 meshes had One of the main advantages of laparoscopic IPOM
to be removed. We have seen no fistula formation is the lower mesh infection rate. The wound infec-
and no intraperitoneal abscesses (⊡ Table 11.2). tion rate is about 2%, and the mesh infection rate is
The rate of fistula to the bladder, colon, or between 1% and 5%. But one point is very impor-
other intestinal organs is very rarely reported in tant: Quite often, the data on IPOM are based on a
the literature, usually occurring when meshes were lot of very easy umbilical and epigastric hernias; the
used that should not be placed intraperitoneally patients whose procedures were converted are not
(heavyweight meshes without a composite struc- included in these data. Also, when a bowel injury is
ture, polypropylene and polyester). reported, it is not clear whether this means a mesh
The data on mesh removal are also very rare. infection. One of the authors, Finan, stated, »This
We know that infected ePTFE is very difficult to study had an 8% rate of laparoscopic hernia repairs
handle, but in our experience, not every infected with a 3.3% wound infection rate compared to a
mesh must be removed in open hernia surgery. 4.5% rate in open permanent mesh repairs, demon-
Infected polyester meshes are quite difficult to strating no meaningful difference« [16].
handle, but lightweight polypropylene meshes are Berger, who reports on only incisional hernia
not especially difficult to treat. In general, they do repairs without any selection, has a very low rate
not need to be removed. of mesh and wound infections–about 1%. We have
Mahmoud Uslu et al. described only two cases seen no wound infections but saw one mesh infec-
11 of 291 patients (modified onlay technique) in which tion caused by an unknown bowel leakage with
it was necessary to reoperate and remove the mesh, peritonitis [9, 19–24] (⊡ Table 11.3).
whereas the infection rate was 2.7% [18].
The wound infection rate in the study of Conze
et al. [7] was very high, up to 18%, with one-third Infections in Inguinal Hernia Repair
of the affected patients needing surgery. The au-
thors did not define mesh infection, but these must In almost all studies, infection occurring with an
have been deep infections; however, mesh removal open and laparoscopic inguinal hernia repair is no
was not necessary. At least, there was no significant problem. Mesh infections are very rare, so they are

⊡ Table 11.2. Our data from 1986 to 2008: infection rates (IPOM intraperitoneal onlay mesh)

N Wound Mesh Mesh Unknown


infections (%) infections (%) removal (%) bowel injury (%)

Incisional hernia total 798 8.9 1.9 0.9 0.1

With mesh 494 6.2 2.8 1.2 0.2

IPOM 222 6.8 4 2.3 0

Onlay 223 7 2.2 0.4 0

Laparoscopic IPOM 49 0 2 2 2

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Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?
83 11
usually not reported; that is why we looked for a rate decreased as the laparoscopic management of
large prospective series. hernias increased up to 29%. The seroma rate was
In the years 1991 to 1999 in the North Rhine between 3% and 5%, but there were documented
area of Germany, there was a program to col- wound infections of 0.79–1.55%, swelling of the
lect all the data on inguinal hernia repair. Nearly scrotum in about 0.7%, and swelling of the testes
200,000 operations were documented. In the data in 0.24–0.52% (as a sign for testicular atrophy in
collection, we discovered that the postoperative the future). The reoperation rate was a bit higher
complication rate was much higher in general than than 1%. These patients are always at risk for
in randomised studies [3, 25–29]: We found a a mesh infection. The mortality rate was 0.1%
complication rate of between 5.1% and 9.7%. This (⊡ Table 11.4).

⊡ Table 11.3. Literature overview of mesh infections in laparoscopic ventral hernia therapy

First author Year N Wound infections (%) Mesh infections (%) Mesh removal (%)

Ferrari [20] 2007 99 1 1 1

Heniford [21] 2000 407 1.23 0.98 0.98

McGreevy [9] 2003 65 – 4.6 4.6

Olmi [31] 2007 85 – 1 1

LeBlanc [23] 2000 100 2 1 1

Berger [22] 2002 150 1.3 1 1

Lammers [own 2008 49 0 2 2


data]

⊡ Table 11.4. Results of inguinal hernia surgery in the North Rhine district of Germany [3]

Year 1999 1998 1997 1996 1995 1994 1993 1992 1991 Total

Patients 19,266 18,619 19,732 20,940 19,646 19,907 19,740 18,738 17,605 173,923

Operations 22,015 21,162 22,212 23,245 21,639 21,888 21,354 20,203 19,000 192,718

Postoperative 5.9 5.6 5.5 5.1 6.4 7.6 7.9 8.1 9.7
complications
(%)

Reoperation 1.10 1.16 1.13 1.12 1.17 1.48 1.42 – – –


(%)

Seroma, 3.85 3.27 3.11 2.8 3.54 4.46 4.39 4.27 5.08
haematoma
(%)

Wound 0.89 0.84 0.90 0.79 1.19 1.31 1.51 1.48 1.55
infection (%)

Swelling of 0.55 0.58 0.56 0.44 0.58 0.75 0.77 0.74 0.81
scrotum (%)

Swelling of 0.26 0.28 0.32 0.24 0.34 0.53 0.49 0.42 0.52
testes (%)
84 Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?

Discussion vention techniques in the North Rhine district. Chirurg


2001; 72:448–452
4. Israelsson LA, Smedberg S, Montomery A, et al. Incisional
The problem of mesh infection in hernia repair
hernia repair in Sweden 2002. Hernia 2006; 10:258–261
does not occur very often, but when it does, there 5. Perez A, Roxas MF, Hilvano SS. A randomized, double-
is always the question of whether the mesh has to blind, placebo-controlled trial to determine effectiveness
be removed. Some studies found that in the case of antibiotic prophylaxis for tension-free mesh hernior-
of an infection with ePTFE, the mesh should be rhaphy. J Am Coll Surg 2005; 200:393–398
6. Yerdel MA, Akin EB, Dolalan S, et al. Effect of single-
removed. Most of the meshes that were developed
dose prophylactic ampicillin and sulbactam on wound
within the last 7 years (light meshes, composite infection after tension-free inguinal hernia repair with
meshes) did not have this problem. Fistula forma- polypropylene mesh. The randomized, double-blind, pro-
tion is not so rare when the wrong mesh is used spective trial. Ann Surg 2001; 233:26–33
intraperitoneally; the rate could be as high as 3.5% 7. Conze J, Kingsnorth AN, Flament JB, et al. Randomized
[1, 19]. Therefore, it is very important to use only clinical trial comparing lightweight composite mesh with
polyester or polypropylene mesh for incisional hernia
approved meshes intraabdominally and perhaps repair. Br J Surg 2005; 92:1488–1493
even avoid intraperitoneal meshes. Mesh infection 8. Lammers BJ, Goretzki PE, Witt M, Röher WM. e-PTFE IPOM
in laparoscopic hernia repair is often associated versus onlay-repair–results of a prospective randomised
with mesh removal, but the data are very sparse. controlled trial. Chir Forum 2001; 30:563–566
When studying the literature, it is very difficult 9. McGreevy JM, Goodney PP, Birkmeyer CM, et al. A pro-
spective study comparing the complication rates be-
to discover the complication rates because many
tween laparoscopic and open ventral hernia repairs. Surg
studies involved a mixture of ventral and incisional Endosc 2003; 17:1778–1780
hernias. 10. Arroyo A, Garcia P, Pérez F, et al. Randomized clinical trial
When looking back at older data, it can be seen comparing suture and mesh repair of umbilical hernia in
that incisional hernia treatment formerly had a adults. Br J Surg 2001; 88:1321–1323
11. Cassar K, Munro A. Surgical treatment of incisional hernia.
high wound infection rate. When prophylactic an-
Br J Surg 2002; 89:534–545
tibiotics were used, the rate decreased to 5–7%. The 12. Langer C, Liersch T, Kley C, et al. 25 Jahre Erfahrung in der
11 infection rate seems to be higher in large series; the Narbenhernienchirurgie. Chirurg 2003; 74:638–645
studies on antibiotics suggest this [25–29]. 13. Ramshaw BJ, Esartia P, Schwab J, et al. Comparison of
But the incidence of mesh-associated infec- laparoscopic and open ventral herniorrhaphy. Am Surg
1999; 65:827–832
tions, including fistula formation, is not clear in
14. Stoppa RE. The treatment of complicated groin and inci-
inguinal hernia repair. In general, a higher com- sional hernias. World J Surg 1989; 13:545–554
plication rate is noted when many hospitals are 15. Iannitti DA, Hope WW, Norton HJ, et al. Technique and
involved in a study. Deep infection, including in- outcomes of abdominal incisional hernia repair using a
fection of the mesh, has a high risk of recurrence synthetic composite mesh: a report of 455 cases. J Am
and reoperation. Coll Surg 2008; 206:83–88
16. Finan KR, Vick CC, Kiefe CI, Neumayer L, Hawn MT. Predic-
In the future, more studies are necessary to tors of wound infection in ventral hernia repair. Am J Surg
look for the advantages related to laparoscopic 2005; 190:676–681
incisional hernia repair. 17. Lammers BJ, Goretzki PE, Otto T. New aspects in hernia
surgery. Urologe 2005; 44:774–779
18. Mahmoud Uslu HY, Erkek AB, Cakmak A, et al. Incisional
hernia treatment with polypropylene graft: results of 10
References years. Hernia 2006; 10:380–384
19. Benhidjeb T, Bärlehner E, Anders S. Laparoscopic incisional
1. Leber GE, Gar JL, Aleander AL, et al. Long-term compli- hernia repair. Chir Gastroenterol 2003; 19(suppl):16–22
cations associated with prosthetic repair of incisional 20. Ferrari GC, Mirando A, Di Lernia S, et al. Laparoscopic
hernias. Arch Surg 1998; 133:378–382 repair of incisional hernia: outcomes of 100 consecutive
2. Lammers BJ, Voos S, Witt M, Goretzki PE. Results of con- cases comprising 25 wall defects larger than 15 cm. Surg
ventional mesh-augmented incisional hernia repair. Chir Endosc 2008; 22:1173–1179
Gastroenterol 2003; suppl 2:24–28 21. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic
3. Lammers BJ, Meyer HF, Huber HG, et al. Developments in ventral and incisional hernia repair in 407 patients. J Am
inguinal hernia surgery based on newly introduced inter- Coll Surg 2000; 190:645–650

[UnitedVRG] - Medical Release Group


Chapter 11 · Mesh Infection Following Hernia Repair: A Frequent Problem?
85 11
22. Berger D, Bientzle M, Müller A. Postoperative compli- Lammers: First of all, we know that patients who
cations after laparoscopic incisional hernia repair. Surg have had an infection in former times from the
Endosc 2002; 16:1720–1723
first operation—for example, for bowel with anas-
23. LeBlanc KA, Booth WV, Whitaker JM, Bellanger DE. Lap-
aroscopic incisional and ventral herniorrhaphy in 100 tomosis leakage, they have bacteria even years
patients. Am J Surg 2000; 180:193–197 after the first operation in the wound. That’s the
24. O’Dwyer PJ, Kingsnorth AN, Molloy RG, et al. Randomized advantage of laparoscopic hernia repair because
clinical trial assessing impact of a lightweight or heavy- you don’t open the same wound again. On the
weight mesh on chronic pain after inguinal hernia repair.
other hand, during open hernia repair there is the
Br J Surg 2005; 92:166–170
25. Sanabria A, Dominguez LC, Valdivieso E, Gabriel G. Pro-
possibility to bring bacteria inside the wound, such
phylactic antibiotics for mesh inguinal hernioplasty: a as from the patient’s skin. But there are no studies
meta-analysis. Ann Surg 2007; 245:392–396 available on this problem at the moment.
26. Kuzu M, Hazinedaroglu S, Dolalan S, et al. Prevention of
surgical site infection after open prosthetic inguinal her-
nia repair: efficacy of parenteral versus oral prophylaxis
with amoxicillin-clavulanic acid in a randomized clinical
trial. World J Surg 2005; 29:794–799
27. Perez A, Roxas MF, Hilvano SS. A randomized, double-
blind, placebo-controlled trial to determine effectiveness
of antibiotic prophylaxis for tension-free mesh hernior-
rhaphy. J Am Coll Surg 2005; 200:393–398
28. Yerdel MH, Akin EB, Dolalan S, et al. Effect of single-
dose prophylactic ampicillin and sulbactam on wound
infection after tension-free inguinal hernia repair with
polypropylene mesh. The randomized, double-blind, pro-
spective trial. Ann Surg 2001; 233:26–33
29. Terzi C, Kilic D, Ünek T, et al. Single-dose oral ciprofloxacin
compared with single-dose intravenous cefazolin for pro-
phylaxis in inguinal hernia repair: a controlled random-
ized clinical study. J Hosp Infect 2005; 60:340–347
30. Korenkov M, Sauerland S, Arndt M, et al. Randomized
clinical trial of suture repair, polypropylene mesh or auto-
dermal hernioplasty for incisional hernia. Br J Surg 2002;
89:50–56
31. Olmi S, Scaini A, Cesana GC, et al. Laparoscopic versus
open incisional hernia repair. An open randomized con-
trolled study. Surg Endosc 2007; 21:555–559
32. Basoglu M, Yildirgan MI, Yilmaz I, et al. Late complications
of incisional hernias following prosthetic mesh repair.
Acta Chir Belg 2004; 104:425–428
33. Bingener J, Buck L, Richards M, et al. Long-term outcomes
in laparoscopic vs open ventral hernia repair. Arch Surg
2007; 142:562–567

Discussion

Read: You mentioned bacteria. Are there any viral


infections of mesh?
Lammers: It may be possible, but I have never seen
it, and I have never heard about this.
Schumpelick: Do you know where the bacteria
come from?
12

Patient Factors as a Major Determinant


of Wound Outcome and Infection After
Surgery
H. W. Hopf
88 Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection After Surgery

Introduction intention can also be optimized. The most impor-


tant factors include attention to perfusion and oxy-
Despite major advances in the management of pa- genation, as with acute wounds; moist wound care;
tients undergoing surgery–including aseptic tech- control of bacterial load; nutrition; edema control;
nique, prophylactic antibiotics, and advances in and prevention of ongoing trauma.
surgical approaches such as laparoscopic surgery–
surgical wound infection remains among the most
common complications of surgery [1]. Wound Wound Repair
complications are associated with prolonged hos-
pitalization and increased resource consumption. Injury damages the local circulation and causes
More than 300,000 surgical site infections occur platelets to aggregate and release a variety of sub-
each year in the United States at an estimated stances, including chemoattractants and growth
cost of more than $1 billion [1]. A growing body factors. The initial result is coagulation, which
of literature supports the concept that patient prevents exsanguination, but also widens the area
factors are a major determinant of wound out- that is no longer perfused. Inflammatory cells
come following surgery. Comorbidities such as (polymorphonuclear leukocytes immediately and
diabetes and cardiac disease clearly contribute, macrophages by 24–48 h) migrate to the wound
but environmental stressors as well as the indi- and are activated in response to endothelial inte-
vidual’s response to stress are equally important. grins, fibrin, lactate, hypoxia, foreign bodies, and
In particular, wounds are exquisitely sensitive to growth factors. In turn, macrophages and lym-
hypoxia, which is both common and preventable. phocytes produce more growth factors and lactate
Perioperative management can be adapted to pro- [2]. Activated inflammatory cells consume oxygen
mote postoperative wound healing and resistance at a high rate, and, coupled with the impaired mi-
to infection. Along with aseptic technique and crocirculation, this results in hypoxia, especially at
prophylactic antibiotics, maintenance of perfu- the center of the wound [3]. Lactate is produced
sion and oxygenation of the wound is paramount. both anaerobically and aerobically, and this results
There is strong clinical evidence that once perfu- in concentrations of 5–15 mM even in well-oxy-
12 sion is assured, the addition of increased inspired genated wounds. Lactate is a strong stimulus for
oxygen substantially reduces surgical site infec- collagen secretion and angiogenesis [4, 5]. Anti-
tions in at-risk patients. inflammatory steroids impair healing by suppress-
It is becoming clear that the intraoperative ing inflammation at this step.
care of patients has repercussions far into the Angiogenesis is required to replace the injured
postoperative period. The impact of anesthetic microcirculation. Platelets release a number of an-
technique on postoperative pain, perioperative giogenic factors, including platelet-derived growth
myocardial ischemia, and vascular graft patency factor, insulin-like growth factor 1, and others. An-
is now well established. Similarly, anesthetic tech- giogenic growth factor levels remain high because
nique can be adapted to promote postoperative of continued production by macrophages and fi-
wound healing and resistance to infection. The broblasts (particularly of fibroblast growth factor
most important factors include temperature man- and vascular endothelial growth factor) in response
agement, increased arterial oxygen tension (PaO2), to hypoxia and lactate, among other things [6]. The
pain control, fluid management, and, as has been capillary endothelial response to angiogenic agents
long recognized, appropriate sterile technique and (i.e., migration into the wound, tubule formation,
administration of prophylactic antibiotics. All but and connecting to sources of blood flow) requires
the last relate particularly to maintaining perfusion oxygen, so angiogenesis progresses proportionally
and oxygenation of the wound. to blood perfusion and arterial PO2 [7].
Even when the best care possible is provided, New blood vessels grow into matrix that is
surgical wounds may become infected or fail to produced by fibroblasts. Fibroblasts replicate and
heal. The progress of wounds healing by secondary migrate mainly in response to growth factors and
Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection
89 12
chemoattractants. Lactate and some growth factors achieved only by maintaining perfusion of injured
induce collagen mRNA synthesis and procolla- tissue [13]. Ischemic or hypoxic tissue, on the
gen production. Posttranslational modification by other hand, is easily infectable and heals poorly, if
prolyl and lysyl hydroxylases is required to allow at all. Wound tissue oxygenation depends on the
collagen peptides to aggregate into triple helices. vascular anatomy, the degree of vasoconstriction,
Collagen can be exported from the cell only when and arterial PO2. Wound tissue oxygenation is
it is in this triple helical structure. The helical con- complex and depends on the interaction of blood
figuration is also primarily responsible for tissue perfusion, arterial oxygen tension, hemoglobin
strength. The activity of the hydroxylases is criti- (Hb) dissociation conditions, carrying capacity,
cally dependent on vitamin C and tissue oxygen mass transfer resistances, and local oxygen con-
tension [8]. Wound strength, which results from sumption.
collagen deposition, is, therefore, highly vulnerable The standard teaching that oxygen delivery
to wound hypoxia. depends more on hemoglobin-bound oxygen (ox-
Angiogenesis and extracellular matrix (primar- ygen content) than on arterial PO2 may be true
ily collagen) production are closely linked. Fibro- of working muscle, but it is not true of wound
blasts cannot produce mature collagen in the ab- healing. In muscle, intercapillary distances are
sence of mature blood vessels that deliver oxygen small, and oxygen consumption is high. In sub-
to the site. On the other hand, new blood vessels cutaneous tissue, on the other hand, intercapillary
cannot mature without a strong collagen matrix. distances are large, and oxygen consumption is
Mice kept in a hypoxic environment (13% inspired relatively low [14]. In uninjured subcutaneous
oxygen) develop some new blood vessels in a test tissue, the intercapillary distance is greater than
wound, but these vessels are immature, with little that in muscle and other highly perfused organs.
surrounding matrix, and demonstrate frequent ar- In wounds, where the microvasculature is dam-
eas of hemorrhage [9]. aged, diffusion distances increase by an order
Epithelial cells move and replicate in response of magnitude. Peripheral vasoconstriction further
to growth factors and oxygen tension, and epi- increases diffusion distance [3]. The driving force
thelization occurs most rapidly in hydrated, well- of diffusion is partial pressure. Hence, a high PO2
oxygenated tissue [10]. is needed to force oxygen into injured and healing
Disruption of the normal skin barrier requires tissues, particularly in subcutaneous tissue, fascia,
that wounds have the ability to clear foreign mate- tendon, and bone.
rial and resist infection. Nonspecific phagocytosis Although oxygen consumption is relatively low
and intracellular killing are the major pathways in wounds, it is consumed by processes that require
activated in wounds [11]. Conversion of oxygen to oxygen at a high concentration. Inflammatory cells
superoxide in phagocytic vacuoles is responsible use little oxygen for respiration, producing energy
for the first step in nonspecific intracellular kill- largely via the hexose-monophosphate shunt [12].
ing, so resistance to infection is critically impaired Most of the oxygen consumed in wounds is used
by wound hypoxia and becomes more efficient for oxidant production (bacterial killing), colla-
as PO2 increases even to very high levels (500– gen synthesis, angiogenesis, and epithelization. The
1,000 mmHg) [12]. rate constants for oxygen for these components
of repair all fall within the physiologic range of
25–100 mmHg [10, 12, 15–18]. This means that
Wound Perfusion and Oxygenation the rate at which repair proceeds varies accord-
ing to tissue PO2 from zero to at least 250 mmHg.
Wound complications include failure to heal, in- In vitro fibroblast replication is optimal at a PO2 of
fection, and excessive scarring or contracture. about 40–60 mmHg. These in vitro observations
Rapid repair has the least potential for infection are clinically relevant. »Normal« subcutaneous
and excess scarring. Repair proceeds most rapidly PO2, measured in test wounds in uninjured, eu-
when wound oxygen levels are high, and this is thermic, euvolemic volunteers breathing room air,
90 Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection After Surgery

is 65±7 mmHg [19]. Thus, any degree of hypoxia These effects are clearly mediated, at least in major
may impair immunity and repair. In surgical pa- part, by raising the partial pressure of oxygen in
tients, the rate of wound infections is inversely pro- the injured tissue.
portional [20], while collagen deposition is directly Greif et al. demonstrated in a randomized,
proportional [21] to postoperative subcutaneous controlled, double-blind trial that in warm, well-
wound tissue oxygen tension. hydrated patients (n=500) with good pain con-
High oxygen tensions (>100 mmHg) can be trol (that is, in well-perfused patients) undergoing
reached in wounds but only if perfusion is rapid major colon surgery, administration of 80% vs.
and arterial PO2 is high [13, 22]. This is because 30% oxygen intraoperatively and for the first 2 h
1) subcutaneous tissue serves a reservoir function, postoperatively significantly reduced the wound
so there is normally flow in excess of nutritional infection rate by 50% [33]. Belda et al. [34] rep-
needs, and 2) wound cells consume relatively little licated these results–noting a significant 40% re-
oxygen, about 0.7 ml/100 ml of blood flow at a duction in surgical site infection–in a random-
normal perfusion rate [14, 23]. At high levels of ized, controlled, double-blind trial in 300 colon
PaO2, this small volume can be carried by plasma surgery patients randomized to 80% vs. 30% oxy-
alone. Contrary to popular belief, therefore, oxy- gen intraoperatively and for the first 6 h postop-
gen-carrying capacity (i.e., hemoglobin concen- eratively. Surgical and anesthetic management was
tration) is not particularly important to wound standardized and intended to support optimal
healing provided that perfusion is normal [24]. perfusion. Myles et al. demonstrated a significant
Wound PO2 and collagen synthesis remain normal reduction in major postoperative complications,
in individuals who have hematocrit levels as low as as well as specific wound infections, in 2,050 ma-
15–18% provided they can appropriately increase jor surgery patients randomized to 80% oxygen in
cardiac output and vasoconstriction is prevented. 20% nitrogen vs. 30% oxygen in 70% nitrous oxide
Peripheral vasoconstriction, which results intraoperatively [35].
from central sympathetic control of subcutane- A smaller (n=165) randomized, controlled
ous vascular tone, is probably the most frequent study by Pryor et al. [36] demonstrated a doubling
and clinically the most important impediment to of surgical site infection in patients randomized
12 wound oxygenation. Subcutaneous tissue is both a to 80% vs. 35% oxygen intraoperatively. The study
reservoir to maintain central volume and a major had a number of methodological flaws, but, more
site of thermoregulation. There is little local regu- importantly, the two groups of patients were not
lation of blood flow, except by local heating [22, equivalent, which likely explained the increase in
25]. Therefore, subcutaneous tissue is particularly infections seen in the 80% oxygen group.
vulnerable to vasoconstriction. Sympathetically Thus, there is substantial evidence that use
induced peripheral vasoconstriction is stimulated of high inspired oxygen intraoperatively and the
by cold, pain, fear, and blood volume deficit [26, administration of supplemental oxygen postopera-
27] and by various medications, including nicotine tively in well-perfused patients undergoing major
(smoking) [19], beta adrenergic antagonists, and abdominal surgery will reduce the risk of wound
alpha-1 agonists, all commonly present in surgi- infection.
cal situations. Prevention and correction of hypo- Concerns about the risk of oxygen toxicity,
thermia [28] and blood volume deficits [29] have including pulmonary fibrosis and atelectasis, have
been shown to decrease wound infections and limited adoption of high inspired oxygen. Oxygen
increase collagen deposition in patients undergo- toxicity is not a risk in the short term (less than
ing major abdominal surgery. Subcutaneous tissue days) and therefore is not pertinent in the operat-
oxygen tension is significantly higher in patients ing room. Some degree of atelectasis is inevitable
with good pain control than in those with poor in all patients undergoing major surgery. Akca et
pain control after knee surgery [30]. Stress also al. [37] demonstrated similar degrees of atelectasis
causes wound hypoxia and significantly impairs in colon surgery patients randomized to 80% vs.
wound healing and resistance to infection [31, 32]. 30% oxygen (balance nitrogen) intraoperatively.
Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection
91 12
Myles et al. found that high inspired nitrous ox- ods of warming such as circulating water blankets
ide caused more atelectasis than high inspired placed under the patient and humidification of
oxygen. Use of positive end expiratory pressure the breathing circuit [42]. Preoperative systemic
appears to abrogate the problem of atelectasis [38]. (forced air warmers) or local (warming bandages)
Thus, these issues should not limit the use of warming techniques have also been shown to de-
high inspired oxygen. Contraindications to the crease wound infections, even in clean, low-risk
use of FiO2 >0.8 include prematurity (retrolental surgeries such as breast surgery and inguinal her-
fibroplasias), recent (possibly lifetime) bleomycin nia repair [43].
administration, use of cautery in the airway or Surgical stress results in increased intravenous
other procedures in which pulmonary or laryngeal fluid requirements. Inflammatory mediators cause
oxygen may leak into the field, and, possibly, acute both vasodilation and an increase in vascular per-
pulmonary conditions. meability [44]. Other known causes of periopera-
Delivery of antibiotics also depends on perfu- tive hypovolemia or fluid loss include preoperative
sion. Parenteral antibiotics given so that high levels mechanical bowel preparation, lack of oral intake,
are present in the blood at the time of wounding fever, preexisting medical conditions, medications
clearly diminish, but do not eliminate, wound in- such as diuretics, and surgical fluid losses, includ-
fections [39]. In one-third of all wound infections, ing evaporation and blood loss.
the bacteria cultured from the wound are sensitive Optimizing the perioperative fluid adminis-
to the prophylactic antibiotic given to the patient, tration remains a controversial challenge. Esti-
even when the antibiotics were given according mates of blood loss, third-space fluid losses, and
to standard procedure. The vulnerable third of maintenance requirements are inaccurate and
patients appear to be the hypoxic and vasocon- may lead to either overreplacement or under-
stricted group. replacement. Currently, most practitioners rely
on their clinical acumen, vital signs such as heart
rate and blood pressure, and urine output to
Intraoperative Management manage perioperative fluids. Due to the com-
pensatory action of peripheral vasoconstriction,
All anesthetics tend to cause hypothermia 1) by surgical patients can be markedly hypovolemic
causing vasodilation, which redistributes heat without a change in any of these variables [13, 21,
from core to periphery in previously vasocon- 45]. Unfortunately, this peripheral vasoconstric-
stricted patients and increases heat loss, and 2) by tion shunts blood away from the skin, increases
decreasing heat production [40]. Vasoconstriction wound hypoxemia, and increases the risk of sur-
is uncommon intraoperatively, as the threshold for gical wound infection [20].
thermoregulatory vasoconstriction is decreased, Current best recommendations include replac-
but it is often severe in the immediate postopera- ing fluid losses based on standard recommenda-
tive period, when anesthesia is discontinued and tions for the type of surgery, replacing blood loss,
the thermoregulatory threshold returns to normal and replacing other ongoing fluid losses (e.g., high
in the face of core hypothermia. The onset of urine output due to diuretic or dye administration,
pain with emergence from anesthesia adds to this hyperglycemia, or thermoregulatory vasoconstric-
vasoconstriction. Maintenance of normothermia tion).
intraoperatively has been shown to decrease the Pain control should be addressed intraopera-
wound infection rate by two-thirds in patients tively so that patients do not have severe pain
undergoing colon surgery [28]. Rapid rewarm- upon emergence from anesthesia. Achieving the
ing of hypothermic patients in the postanesthesia goal is more important than the technique used to
care unit (PACU) also appears to be effective [41]. do so. Although regional anesthesia/analgesia may
Maintenance of a high room temperature or forced provide superior pain relief, the effects of specific
air warming before, during, and after the operation analgesic regimens on wound outcome have not
are significantly more effective than other meth- yet been studied.
92 Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection After Surgery

Postoperative Management increases intracapillary distance, so there may be


a delicate balance between excessive edema and
Wounds are most vulnerable in the early hours. peripheral vasoconstriction (which worsens the
Although antibiotics lose their effectiveness after hypoxia caused by edema).
the first hours, natural wound immunity (oxygen-
related) lasts longer [46]. Even a short period of
vasoconstriction during the first day is sufficient to Care of Wounds Healing by Secondary
reduce oxygen supply. Correction and prevention Intention
of vasoconstriction in the first 24-48 h after sur-
gery will have significant beneficial effects. Even with appropriate perioperative management,
All vasoconstrictive stimuli must be corrected some wounds become infected or fail to heal. Fre-
simultaneously to allow optimal healing. Volume quently this may result from other causes of im-
is the last to be corrected because vasoconstric- paired perfusion, such as obesity, prior radiation to
tion for other reasons induces diuresis and ren- the area, arterial insufficiency, or excessive edema.
ders the patient hypovolemic (peripherally, not It may also result from other problems such as
centrally). malnutrition, overwhelming contamination, or
Assessing perfusion, especially in the PACU, ongoing trauma. If it is a simple case of infection,
is critical. Unfortunately, urine output is a poor the wound will generally heal rapidly by secondary
and often misleading guide to peripheral perfu- intention with just attention to basic care. If other
sion [47]. Markedly low output may indicate de- complicating factors are involved, it may take more
creased renal perfusion, but normal or even high effort to achieve healing. In either case, the most
urine output has little correlation to wound/tissue modern and advanced healing devices will not
PO2. Many factors commonly present in the pe- succeed if proper care is not instituted, so attention
rioperative period, including hyperglycemia, dye to basic proper wound care is crucial to ensure
administration, thermoregulatory vasoconstric- success:
tion, adrenal insufficiency, and various drugs, may 1. Reduce the bacterial load. The best way to
cause inappropriate diuresis in the face of mild achieve this is to wash the wound gently with
12 hypovolemia. mild soap in a warm shower. All open wounds
Physical examination of the patient is a better are contaminated with bacteria. Most bacterial
guide to dehydration and vasoconstriction. Va- contamination comes from bacteria normally
soconstriction can be determined by a capillary resident on the skin. A shower provides the
return time of more than 1.5 s at the forehead and volume to wash away the bacteria; rinsing
more than 5 s over the patella. Eye turgor is an- with normal saline does not provide adequate
other good measure of hydration. Finally, patients volume. Moreover, saline is generally kept
can usually distinguish thirst from a dry mouth. refrigerated or at room temperature and thus
Skin should be warm and dry. will tend to induce local vasoconstriction,
When excessive tissue fluids have accumulated, whereas a warm shower will tend to induce lo-
diuresis should be undertaken gently so that tran- cal vasodilation. Mild soap provides sufficient
scapillary refill can maintain blood volume. This detergent effect to assist in dislodging bacteria.
applies to patients who need renal dialysis as well. Antibacterial agents, including antibacte-
The average dialysis patient vasoconstricts suf- rial soaps, Betadine, bleach, Dakin’s solution,
ficiently to lower tissue PO2 by 30% or more dur- hydrogen peroxide, and alcohol, are effective
ing dialysis and needs about 24 h for vasomotor at reducing bacterial load, but they do so at
tone and wound/tissue PO2 to return to normal the cost of inactivating white cells and harm-
[48]. Fluid losses from the vascular system are not ing granulating tissue. Thus, wounds treated
necessarily replaced from the tissues as rapidly as with these agents are very clean but frequently
they are sustained. Tissue edema may be the price demonstrate minimal evidence of healing
paid for adequate intravascular volume. Edema (granulation tissue).
Chapter 12 · Patient Factors as a Major Determinant of Wound Outcome and Infection
93 12
2. Maintain a moist wound environment. Moist proves wound healing at pharmacologic (more
wounds heal about 50% faster than dry ones than nutritional) levels [52]. Arginine-con-
[49, 50]. Any number of products may pro- taining protein supplements are available, and
vide the proper environment, depending on arginine capsules can be obtained at health
the wound. Traditional wet-to-damp dress- food stores. Vitamin A and zinc deficiencies
ings should be replaced as the standard of impair wound healing, and these should be re-
care and essentially never used. They are less pleted. A 10-day course (25,000 IU vitamin A
cost-effective than any other dressing on the and 220 mg zinc daily) is sufficient, as both
market because they have minimal ability to may be toxic in excess. Vitamin A specifically
manage exudates and they induce maceration reverses impaired healing resulting from ste-
of the surrounding skin, thereby potentially roids [53, 54]. Topical vitamin A and D oint-
actually enlarging the wound; they pull off ment (sold for diaper rash over the counter)
granulation tissue as they debride necrotic applied once daily works well.
tissue and slough, thus prolonging healing. 4. Pay attention to perfusion. Patients should
They also provide no protection against bacte- be instructed to quit smoking, drink plenty
rial contamination (nonocclusive), must be of fluids, manage their pain aggressively, and
changed three times a day (TID), and cause keep their wound covered or insulated for
more discomfort. Although a single sheet of warmth. Stress reduction is also likely to be
gauze is inexpensive compared with a typical beneficial.
$10–20 modern dressing, more than one piece
of gauze is used with each dressing change,
and the dressing must be changed TID, thus Summary
raising the supply cost at least as high as more
sophisticated dressings that are only changed In patients with moderate to high risk of surgi-
daily or less often. The labor costs of wet- cal site infection, surgeons and anesthesiologists
to-damp dressings are therefore also higher. have the opportunity to enhance wound healing
Moreover, home care nurses cannot provide and prevent wound infections by simple, inex-
TID dressing changes, which may delay hos- pensive, and readily available means [55, 56]. In-
pital discharge. Finally, given that dressing traoperatively, appropriate antibiotic use, preven-
changes often cause discomfort, less frequent tion of vasoconstriction (volume, warming), and
changes are clearly a benefit. So use whatever maintenance of a high PaO2 (300–500 mmHg) are
you want, but don’t use wet to damp! Of note, key. Postoperatively, the focus should remain on
gauze impregnated with a nonevaporating preventing vasoconstriction through pain relief,
substance such as Aquaphor, silver sulfadiaz- warming, and adequate volume administration in
ine, or a hydrogel does make an excellent filler the PACU.
for deeper wounds.
3. Pay attention to nutrition. Recent intake
(7 days) is most important [51]. Be aware of a References
patient’s NPO status leading to missed meals.
1. Kaye, K.S., et al., Preoperative drug dispensing as predic-
Key elements include protein, which is re-
tor of surgical site infection. Emerg Infect Dis, 2001. 7(1):
quired to make the extracellular matrix but is pp. 57–65
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tive wounds, and vitamin C, an essential cofac- human wound fluid. Surgery, 1992. 112(1): pp. 18–23
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healing wounds., in Soft and hard tissue repair, T.K. Hunt,
in collagen posttranslational modification) as
R.B. Heppenstall, and E. Pines, eds. 1984, Praeger: New
well as essential for proper neutrophil func- York. pp. 50–66
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portant, although the amino acid arginine im- healing: Angiogenesis and collagen systhesis stimulated
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in vivo by resident and activated wound macrophages. 24. Hopf, H. and T. Hunt, Does–and if so, to what extent–nor-
Surgery, 1984. 96: pp. 48–54 movolemic dilutional anemia influence post-operative
5. Jensen, J.A., et al., Effect of lactate, pyruvate and pH on wound healing? Chirugische Gastroenterologie, 1992. 8:
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6. Schultz, G. and M. Grant, Neovascular growth factors. Eye, flow and oxygen tension in wounds. Arch Surg, 1987.
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Discussion

Terzi: Is there any risk for patients in giving high


oxygen?
Hopf: Giving patients 100% oxygen is largely risk-
free. If they are newborns, you should probably
avoid 100% oxygen. So for everybody who is afraid
13

Mesh-Related Infections After Hernia


Repair
M. E. Falagas, G. C. Makris
98 Chapter 13 · Mesh-Related Infections After Hernia Repair

Introduction ▬ Perioperative administration of prophylactic


antibiotics and type of sterile techniques ap-
Open or laparoscopic »tension-free« mesh implan- plied in the operating room
tation for hernia repair of abdominal wall defects ▬ Mesh placement in contaminated tissues
has been the gold standard treatment because it ▬ Other factors, such as smoking and immuno-
appears to reduce the rate of recurrence by an suppression
average of 30–50% in comparison with the simple
nonmesh herniorrhaphy. However, the use of artifi-
cial meshes within the human body is not without Incidence of Mesh-Related Infections
potential clinical problems and might lead to vari-
ous complications such as seromas (fluid accumu- Elective primary abdominal reconstruction with
lation), adhesions, chronic severe pain, migration mesh is considered a clean surgery, with infection
or even rejection of the mesh, and, of course, rates of up to 8% being reported [1]. The rate of
mesh-related infections [1, 2]. These complications infection may vary among centers and appears to
may even be life-threatening and usually neces- be influenced by underlying comorbidity (diabe-
sitate hospitalization and surgical removal of the tes, immunosuppression, obesity) and by specific
troublesome mesh. factors mentioned earlier, which will be discussed
Mesh-related infections, along with seroma in following sections.
formation, are the most common complications
encountered during ventral or inguinal hernia re-
pair, although infection is definitely the one with Operating Technique and Type of Mesh
the most devastating consequences for the patient.
Every year almost 30,000 inguinal and just as Laparoscopic hernioplasty compared with open
many ventral hernia repairs become infected, both mesh procedures has been proven to induce a lower
in the United States and Europe. New improved incidence of surgical wound infections, probably
techniques and stricter aseptic protocols in the due to the lack or relatively limited physical contact
operating room have contributed to a decrease in of the mesh with the surgical wound during the op-
wound infection rates after hernia repair, but this eration. However, the specific type of laparoscopic
still appears to be center dependent. technique used (transabdominal preperitoneal ver-
sus totally extraperitoneal mesh implementation) is
13 not associated with different rates of infections, but
Risk Factors data are still insufficient to support this statement.
The type of implemented mesh is also of vital
The risk factors for surgical site infections (SSIs) importance regarding the development (or not) of
in herniorrhaphy are gender (female > male), age an infection [3]. Monofilament polypropylene (PP)
over 70, comorbidities (diabetes, obesity), operat- is the most frequently used biomaterial for repair of
ing time, and the prophylactic use of drainage or an abdominal wall defect due to the low infection
prostheses. Even though artificial implants pose rates compared with other nonabsorbable types of
an independent risk factor for the development of meshes. The biocompatibility and the large pore
SSIs, other factors also affect the incidence of pos- size of this PP textile permit the relatively uncom-
therniorrhaphy mesh-related infection rates [1]: promised inflammatory response of the immune
▬ Type of mesh [polyester, polypropylene (PP), system on the surface of this material. Engelsman
or polytetrafluoroethylene (PTFE)] et al. [3] reviewed the infection rates of different
▬ Type of surgical technique used to apply the kinds of nonabsorbable meshes after open repair
mesh (laparoscopic or open) hernioplasty and noted important variations:
▬ Relationship of the mesh to the peritoneum ▬ Polypropylene meshes: 2.5–5.9%
(transabdominal preperitoneal or totally extra- ▬ Expanded polytetrafluoroethylene (ePTFE)
peritoneal) meshes: 0–9.2%
Chapter 13 · Mesh-Related Infections After Hernia Repair
99 13
▬ Polyester meshes: most polyester infection ra- Smoking and Other Comorbidities
tes are quite similar to those of polypropylene
meshes, but rates of up to 16% have also been Smoking, prolonged operating time, and patient
documented comorbidities such as diabetes, immunosuppres-
sion, and obesity have been incriminated for a
Surgical technique and patient and mesh charac- further increase in the incidence of surgical wound
teristics are responsible for the above differences. infections after hernioplasty.
The pathophysiologic mechanisms and certain
characteristics of the meshes underlying the above
differences will be discussed in a following para- Microbiology and Pathophysiology
graph. of Mesh-Related Infections

The isolated microflora in mesh-related infections


Antimicrobial Prophylaxis and are usually associated with Staphylococcus species,
Preoperative Aseptic/Sterilization especially S. aureus; Streptococcus spp., including
Protocols group B streptococci; and Gram-negative (mainly
Enterobacteriaceae) and anaerobic bacteria [5]. In
Preoperative administration of antimicrobial addition, microbiological data confirm that strains
agents in clean surgical procedures such as pri- of methicillin-resistant S. aureus have been isolated
mary hernioplasty has been a matter of consider- in mesh-related infections after hernia repair, as
able debate for years, but a recent meta-analysis have Candida spp. and Mycobacterium spp., al-
by Sanabria et al. [4] of the accumulated evidence though to a far lesser extent.
suggests that infection rates were decreased by Microbes have an extraordinary ability to ad-
almost 50% in the patients who received antimi- here to surfaces to produce colonies and maintain
crobial prophylaxis. their functional status. In particular, certain patho-
Stricter operative aseptic protocols in combi- gens, including S. aureus, may adhere even to arti-
nation with proper prophylactic antibiotic cover- ficial surfaces such as metal and cause implant-re-
age was also demonstrated to be effective in fur- lated infections. Bacteria may adhere to inanimate
ther restricting surgical posthernioplasty wound surfaces, produce slime (which causes stronger and
infections in a large series of patients who under- irreversible adhesion), and form biofilms, which
went »clean« surgical repair of abdominal wall have the ability to communicate through quorum
defects. sensing and resist internal mechanisms of defense.
In addition, they build tight junctions with the un-
derlying biomaterial, creating complex, large struc-
Mesh Placement in Contaminated tures that are not easily ingested by phagocytes.
Areas Highly porous material with a large surface
area and numerous niches–such as the multifila-
Hernia repair is considered a clean operation. ment meshes–provides pathogens with an excel-
Nevertheless, when bowel opening or abdominal lent environment protected from the immune sys-
wound infection has previously occurred, this pro- tem of the host. Niches function as a shelter for
cedure becomes contaminated; thus, the imple- the pathogens’ colonies because of the large size
mentation of an artificial material was thought of phagocytes. Niches are small in diameter, but at
for years to be contraindicated. However, recent the same time, they substantially increase the total
studies suggest that minor morbidity, minimal risk area of the mesh, raising the possibility for success-
of infection, and minor wound-related mortality ful bacterial adherence [6]. Porous materials are
are observed after mesh placement in contami- connected with higher infection rates because they
nated tissues. Apparently, more solid evidence is downsize the normal inflammatory response of
required. the infected host organism.
100 Chapter 13 · Mesh-Related Infections After Hernia Repair

Finally, the hydrophobic or hydrophilic proper- fections may result from persistent fluid collection
ties of implanted materials also influence the adher- (seromas) leading to chronic groin sepsis. Symp-
ing pattern of bacteria upon them, since they deter- toms can be chronic, recurrent, or totally absent
mine protein absorption from the surface of the until the progression to sepsis.
biomaterial. In vitro studies have shown that more
hydrophobic materials, such as PTFE and ePTFE,
may be associated with the development of more Diagnosis
resistant forms of biofilms [6]. The above results
may explain previous clinical findings that infec- The combination of clinical presentation, physical
tions related to multifilament, hydrophobic ePTFE examination, laboratory values, and previous medi-
and PTFE meshes are expected to have the worst cal history is usually adequate to establish a diagno-
prognosis and demand surgical management. sis. However, when there are doubts regarding dif-
ferential diagnosis, two noninvasive imaging tech-
niques could provide physicians with a solution:
Clinical Manifestation and Diagnosis Bedside ultrasound and computerized tomography
may reveal the inflammatory process in the adipose
The manifestations of mesh-related infections can tissue around the implant because of the different
be divided into surgical (superficial) wound infec- ultrasonic and density characteristics, respectively.
tions and deep-seated mesh infections and may Complications such as the presence of fistula or
occur 2 weeks to 39 months from the day of mesh abscess could also be depicted. Diagnostic paracen-
implantation. tesis of mesh-associated seromas when there are no
signs of inflammation should be carefully consid-
ered and not performed routinely; there is a high
Surgical Wound Infections risk of transforming a potentially aseptic reaction
to an infectious process through the introduction
Surgical wound infections are the most commonly of bacteria into the previously aseptic seromas.
encountered type of infection, presenting at an
early postoperative stage, usually days or a few
weeks after the mesh placement. The symptoms Treatment and Antimicrobial
and signs are typical of local acute inflammation: Prophylaxis
13 pain, erythema, swelling with locally increased
temperature, and confined tenderness. Therapeutic Options:
Inappropriate treatment of surgical wound in- Surgical or Conservative
fections may be complicated by the formation of
a discharging fistula, intraabdominal abscess, or, The therapeutic options available following the
rarely, osteomyelitis. The emergence of systemic development of mesh-related infection can be sep-
symptoms such as fever, chills, or rigor and malaise arated according to the type and severity of infec-
should urge prompt investigation and initiation of tion and the type of implanted mesh.
therapeutic actions before sepsis occurs. ▬ Posthernioplasty superficial wound infections
may have a better prognosis and may be tre-
ated conservatively using proper intravenous
Deep-Seated Mesh Infections antimicrobial coverage and drainage when
signs of accumulated exudate exist. However,
Deep-seated mesh infections generally manifest the use of drainage is still controversial due to
in the early postoperative period, but infrequently insufficient evidence.
they can also be observed as a late-onset phenom- ▬ In limited, deep-seated infections of the mesh,
enon that is delayed for months or years (up to prolonged antibiotic treatment in combina-
4.5 years after the operation) [7]. Deep-seated in- tion with percutaneous or open drainage has
Chapter 13 · Mesh-Related Infections After Hernia Repair
101 13
been reported to be effective to restrain the are warranted to establish evidence-based algo-
infectious process. However, when extensive rithms for treating infections according to the type
infection is present–due to biofilm formation and severity of infection and the type of mesh.
and limited penetration of the drug in the
area–mesh removal and surgical cleaning of
the wound pose the best possible treatment Prophylaxis
to eradicate the infection. Unfortunately, the
labeling of a mesh-related infection as limited Due to the special features of implant devices,
or extensive remains empirical. Hernia recur- the best way to treat an implant-related infection
rence could be a postoperative complication without destroying the implant is to take the ap-
if adequate fibrous tissue had not developed propriate measures to avoid initial exposure to
earlier (early-onset, deep-seated infections). infectious agents. Considerable effort has been
▬ The choice between conservative and surgical made to develop techniques that will restrain the
treatment could also be influenced by the type fundamental mechanisms for implant-related in-
of implanted mesh. Structural (monofilament fections, which are bacterial adhesion and coloni-
or multifilament) and biochemical (hydro- zation of artificial surfaces and biofilm formation.
phobic or hydrophilic) properties influence Various strategies such as antimicrobial prophy-
the potential response of the infection to the laxis and mesh coatings of antimicrobial biomate-
administered antibiotics. Clinical findings in rials have been developed, but so far, comparative
combination with recent in vitro experiments data are lacking.
suggest that infected hydrophobic meshes– Preoperative antimicrobial prophylaxis in elec-
such as PTFE and ePTFE–are most likely to be tive, »clean« surgical procedures such as repair of
removed in order to achieve complete cure. an abdominal wall defect with a mesh has been
a matter of considerable controversy for years.
So far, no universal recommendations based on Nevertheless, recent meta-analysis of accumulated
randomized controlled trials exist for the optimal data provides evidence of significantly lower SSI
treatment of mesh-related infections. Further data rates after proper prophylaxis. The antimicrobial

Hospital surgical
site infection rate

High (>1%) Low (<1%)

Preoperative Assess individual


prophylaxis risk factors

High-risk patient Low-risk patient

Preoperative ⊡ Fig. 13.1. Proposed algorithm


prophylaxis No preoperative for preoperative antimicrobial
prophylaxis prophylaxis
102 Chapter 13 · Mesh-Related Infections After Hernia Repair

agents most commonly used are cefazolin 1–2 g 5. Falagas ME, Velakoulis S, Iavazzo C, Athanasiou S. Mesh-
(or 1 g erythromycin if the patient is allergic), 1.5 g related infections after pelvic organ prolapse repair sur-
gery. Eur J Obstet Gynecol Reprod Biol 2007; 2:147–156
ampicillin/sulbactam , 2 g amoxicillin/clavulanic
6. Engelsman AF, van der Mei HC, Busscher HJ, Ploeg RJ.
acid, or 1.5 g cefuroxime. Unfortunately, there are Morphological aspects of surgical meshes as a risk factor
still no data regarding the cost-effectiveness of this for bacterial colonization. Br J Surg 2008; 8:1051–1059
approach. Infection rates can be center dependant 7. Delikoukos S, Tzovaras G, Liakou P, Mantzos F, Hatzitheo-
and can be as low as 1% in some cases. Therefore, filou C. Late-onset deep mesh infection after inguinal
hernia repair. Hernia 2007; 1:15–17
researchers have suggested that institutions revise
8. Eriksen JR, Gögenur I, Rosenberg J. Choice of mesh for la-
their SSI rates and decide, according to each pa- paroscopic ventral hernia repair. Hernia 2007; 6:481–492
tient’s special risk factors, whether antimicrobial
prophylaxis is justified. (See ⊡ Fig. 13.1).
Mesh coating with antimicrobial agents or
other biomaterials that decrease the adhesion abil- Discussion
ity of bacteria, increase host tissue ingrowth, or
initiate bacterial destruction have been developed Heniford: When I talk to our patients about lap-
to prevent implant colonization and biofilm for- aroscopic versus open ventral hernia repair, the
mation in the first place. Apart from antibiotic number one reason to recommend laparoscopic
coatings (such as cefoxitin), silver, gold, titanium repair is not pain, and it is not cosmetics—it’s a
carbonitride, polyglactin, gelatin, and other bio- decreased risk of infection, by far. When we look
materials have been used as coatings, with differ- back at our patients and compare the different
ent mechanisms of action. At present, however, risk factors for infection, the number one reason
evidence is based on experimental and animal is smoking.
studies, and the available comparative data are
insufficient to draw safe conclusions
Universal recommendations regarding the
choice of mesh type or the best possible antimi-
crobial prophylaxis cannot be supplied based on
the available evidence from randomized controlled
trials [8]. Until further trials are completed to shed
more light on these controversial issues, the choice
13 of mesh and antibiotic coverage will be center
dependent and, in particular, derived from the sur-
geon’s experience and the financial cost.

References

1. Falagas ME, Kasiakou SK. Mesh-related infections after


hernia repair surgery.
Clin Microbiol Infect 2005; 1:3–8
2. Bliziotis IA, Kasiakou SK, Kapaskelis AM, Falagas ME. Mesh-
related infection after hernia repair: case report of an
emerging type of foreign-body related infection Infection
2006; 1:46–48
3. Engelsman AF, van der Mei HC, Ploeg RJ, Busscher HJ. The
phenomenon of infection with abdominal wall reconst-
ruction. Biomaterials 2007; 14:2314–2327
4. Sanabria A, Domínguez LC, Valdivieso E, Gómez G. Pro-
phylactic antibiotics for mesh inguinal hernioplasty: a
meta-analysis. Ann Surg 2007; 3:392–396
14

Human Acellular Dermal Matrix


for Ventral Hernia Repair in the
Compromised Surgical Field
J. J. Diaz
104 Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair in the Compromised Surgical Field

Introduction can become vascularized and resist infection. In


addition, the ideal product must have the tensile
Repair of a ventral hernia is one of the most com- strength of native fascia or be comparable to pros-
mon surgical procedures performed in the United thetic mesh, be pliable, and be easy to implant.
States. Yet ventral hernia repair in the setting of To date, only human acellular dermal matrix has
a contaminated surgical field presents a very dif- demonstrated its ability to resist infection.
ficult surgical dilemma. Prosthetic mesh has been The development of human acellular dermis
widely employed since the 1950s for the elective (HADM) as a fascial graph replacement presents a
repair of ventral hernias. Beyond hernia recur- potential alternative to hernia closure in a compro-
rence, prosthetic mesh has known complications mised surgical field. HADM is derived from hu-
such as infection, contracture, and intestinal fistula man donors (LifeCell, Branchburg, NJ, USA). The
formation. In the setting of a clean-contaminated donated human skin is supplied by the American
and/or dirty surgical field, prosthetic mesh is con- Association of Tissue Banks and is approved by the
traindicated due to high complication rates [1–4]. U.S. Food and Drug Administration as banked hu-
The alternative, closing of a ventral hernia with man tissue. Under a proprietary process, HADM
an absorbable mesh, presents its own set of prob- is cleansed of any immune reactive cells or cel-
lems. Repair with absorbable mesh only serves lular components. HADM is being used to reduce
to keep the patient from evisceration. It is a tem- complications seen with prosthetic mesh, such as
porizing procedure for a planned ventral hernia infection, adhesions, fistulas, seromas, bleeding,
repair, and it continues to be associated with a high and skin erosion [10, 11].
rate of wound infection that is unaffected by the
use of an absorbable mesh [5–7].
Repair Types

Patient Population The most common ventral hernia repair types


mesh to »bridge« the defect using a tension-free
Patients with complex hernias remain a very dif- repair. A prosthetic mesh with 3–4 cm of overlap
ficult group to repair. Complex hernias are com- of the fascial edge has been used as an onlay or
monly described as follows: open abdomen after sublay [12, 13]. Interposition mesh placement is
trauma/emergency; general surgery resulting in a well known to have the highest recurrence rate
planned ventral hernia; presence of an intestinal and is not a recommended surgical technique.
fistula, ostomy, or infected mesh. Patients who have Luijendijk et al., in the only randomized controlled
14 a history of multiple hernia repairs, loss of domain, trial of mesh vs. primary suture repair, showed that
or loss of abdominal tissue and musculature are the rate of hernia recurrence could be reduced by
also labeled as having complex hernias. Patients using a prosthetic mesh [12].
with a previous history of infected mesh or wound We hypothesized that a human acellular der-
infection have a high risk of developing another mal matrix would be a suitable biological tissue
surgical site infection [8, 9]. In all of these cases, alternative for repairing ventral hernia in the pres-
the use of prosthetic mesh would be considered a ence of a contaminated surgical field by better
contraindication in hernia repair. To date, no classi- tolerance to wound infection, thereby reducing the
fication system is universally accepted for defining incidence of prosthesis removal.
ventral hernias. A ventral hernia can range from
a simple periumbilical hernia in a patient with no
comorbidities to an abdominal catastrophe with a Methods
planned ventral hernia, a split-thickness skin graft
over the viscera, and an atmospheric fistula. We performed a retrospective study of a single
Manufacturers have started to develop biologi- institution’s experience with HADM (⊡ Fig. 14.1).
cal mesh with the intent to produce a product that Patients were admitted from January 2001 to
Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair
105 14
All study patients
N=75

Clean-contaminated Contaminated or dirty


N=64 N=11

SSI SSI

Yes No Yes No
N=21 N=43 N=4 N=7

Medically Surgically Medically Surgically


managed managed managed managed
N=9 N=12 N=2 N=2

⊡ Fig. 14.1. Study design


Mesh removed =4 Mesh removed =1
(SSI surgical site infection)

December 2004 to Vanderbilt University Medi- ous fistula. The medical center’s electronic data
cal Center and included surgical cases from the repository (StarPanel) and hospital administrative
trauma, general surgery, and emergency general database were used to accurately collect patient
surgery services. Before the study began, approval data. Demographic data collected (⊡ Table 14.1)
was granted by the Vanderbilt University Institu- included age, gender, race, hospital length of stay,
tional Review Board. and comorbidities, which in turn included dia-
betes mellitus, hypertension, renal insufficiency
(serum creatine <30 mg/h), chronic obstructive
Study Population pulmonary disease, heart disease, and hepatic dis-
ease (cirrhosis).
Patients were included if they were greater than The wound classification was recorded for each
15 years of age and had undergone repair of a patient. The Centers for Disease Control and Pre-
ventral hernia or traumatic anterior wall fascial vention (CDC) wound classification system was
defect with acellular human dermis (AHD) in a used to define surgical wounds [10] (⊡ Table 14.2).
compromised surgical field. Surgical involvement The operative technique for each hernia repair was
of the following organ systems was required for also recorded (⊡ Table 14.3). The type of suture
inclusion: stomach, small bowel, colon, appendix, used for each AHD repair (absorbable vs. perma-
hepatobiliary system, urinary bladder, spleen, and nent) was also recorded in the database. The study
ostomy formation. This also included removal population was divided into two groups: clean-
of infected mesh or repair of an enterocutane- contaminated (CC) and contaminated/dirty (CD).
106 Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair in the Compromised Surgical Field

⊡ Table 14.1. Study demographics ⊡ Table 14.2. Wound classification

n 75 Wound Wound criteria


classification
Value % / SD
Clean Elective, not emergency, nontrau-
Age 51.5 14.5
matic; primarily closed; no acute
Gender inflammation; no break in tech-
nique; respiratory, gastrointestinal,
Male 36 48.0
biliary, and genitourinary tracts not
Female 39 52.0 entered

Race (%) Clean-con- Urgent or emergency case that is


taminated otherwise clean; elective opening of
White 60 80.0
respiratory, gastrointestinal, biliary,
Black 11 14.7 or genitourinary tract with minimal
spillage (e.g., appendectomy); no en-
Other 5 6.7
countering of infected urine or bile;
Comorbidity (%) minor technique break

Cardiac 15 20.0 Conta- Nonpurulent inflammation; gross


minated spillage from gastrointestinal tract;
Hypertension 34 45.3
entry into biliary or genitourinary
Diabetes mellitus 23 30.7 tract in the presence of infected bile
or urine; major break in technique;
Renal 4 5.3
penetrating trauma <4 h old; chronic
Chronic obstructive 5 6.7 open wounds to be grafted or cov-
pulmonary disease ered

Hepatic 3 4.0 Dirty Purulent inflammation (e.g., abscess);


preoperative perforation of respira-
Chronic steroids 4 5.3
tory, gastrointestinal, biliary, or geni-
Hospital tourinary tract; penetrating trauma
>4 h old
Length of stay 16.7 20.8

Charges $158,183 $206,896

Disposition (%)
⊡ Table 14.3. Operative repair type
14 Died (sepsis) 1 1.3

Home 56 74.7 Repair type Repair description

Transfer /rehabilitation 18 24.0 Inlay (sublay) Reinforcing sheet of acellular human


dermis is positioned deep to the an-
terior abdominal wall defect

Outcomes Onlay Reinforcing sheet of acellular human


dermis is positioned superficial to
the defect
The primary outcome measured in this study was
the incidence of surgical site infection (SSI) as per Component Releasing incisions are made in the
separation external oblique muscle with rectus
the CDC definitions for nosocomial infections.
reinforcement with acellular human
Management of the wound infection was divided
dermis
into medical management (intravenous antibiotic
only) and surgical management (operative incision Interposition The edges of the acellular human
dermis graft are sutured directly to
and drainage plus intravenous antibiotics). Also
the edges of the fascial defect
recorded was whether the AHD was removed.
Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair
107 14
Secondary variables included early hernia re- were medically managed (14.1%) and 12 wound
currence (<1 year); septic complications, including infections that were surgically managed (18.8%).
ventilator-associated pneumonia; urinary tract in- The CD group (n=11) had two wound infections
fection; and blood stream infection. that were medically managed (18.2%) and two that
were surgically managed (18.2%). Five of 14 surgi-
cally managed (35.7%) wound infections required
Statistics removal of the mesh.

Statistical analysis was performed using chi-square


tests to evaluate statistical significances between Subgroup Analysis
patient subgroups.
The patient population was divided into two sub-
groups based on wound type: clean-contaminated
Results (CC) and contaminated or dirty (CD). Sixty-four
patients had CC wounds, and 11 patients had CD
Seventy-five patients met the study criteria. The wounds (⊡ Table 14.4). Within the CC group, there
overall wound infection rate was 33.3%: 11 medi- were 21 SSI: 9/64 patients (14.1%) were medi-
cally managed infections (14.7%) and 14 surgically cally managed, and 12/64 patients (18.8%) were
managed infections (18.7%). The average length surgically managed. Of the 12 surgically managed
of hospital stay was 16.7 days (+20.8) with a mean wound infections, five necessitated removal of the
follow-up of 275 (+209) days. HADM (33.3%) either because of enterocutaneous
With respect to the entire patient population, fistula formation (n=4) or HADM infection (n=1;
25 out of 75 patients (33.3%) developed an SSI, see ⊡ Table 14.5). Within the follow-up period (av-
and 12 patients had hernia recurrence (16%). The erage 269 days), a total of 12 patients (16%) in the
CC group (n=64) had nine wound infections that CC group experienced hernia recurrence.

⊡ Table 14.4. Clean-contaminated (CC) and contaminated/dirty (CD) subgroup analysis (HR hernia recurrence;
LOS length of stay; WC wound closure during initial procedure; FUD follow-up days

Groups n HR (%) LOS (SD) WC (%) FD (SD)

Clean-contaminated 64 10 15.6 15.4 19.6 64 100 269 186

Contaminated/dirty 11 2 18.2 24.3 27.7 8 72.7 306 277

Total 75 12 16.0 19.8 23.6 72 96 275 201

⊡ Table 14.5. Inpatient infection rate (MM medical management; SM surgical management)

n (%) Inpatient

Total (%) MM (%) SM (%)

Clean-contaminateda 64 85.3 21 32.8 9 14.1 12 18.8

Contaminated/dirty 11 14.7 4 36.4 2 18.2 2 18.2

Totals 75 100 25 33.3 11 14.7 14 18.7


aMesh
removal in five patients
108 Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair in the Compromised Surgical Field

Surgical Technique and Suture Analysis nia recurrence, at 10.5%. Again, the differences
between infection and recurrence rates were not
Outcomes were also evaluated with respect to the statistically significant. It should be noted that the
type of hernia repair implemented (⊡ Table 14.6). type of suture used in five patients was unknown,
The ventral hernia repair type with the lowest and two developed a surgical wound infection
occurrence of wound infection was the onlay tech- (⊡ Table 14.7).
nique (n=15), with 6.7% of patients developing It was concluded that wound infection in the
an SSI. This was followed by inlay (n=27; 33.3%), contaminated surgical field occurred 33.3% of the
interposition (n=23; 43.5%), and component sepa- time; 18.7% of the cases required surgical manage-
ration (n=10; 50%). The repair method most suc- ment, and 35.7% of these required removal of the
cessful at preventing hernia recurrence was the HADM.
inlay method, with only 7.4% of patients devel-
oping a secondary hernia. This was followed by
component separation (10%), onlay (13.3%), and Discussion
interposition (30.4%). Although general trends in
differences in wound infection and hernia recur- Because of the high rates of infection, hernia re-
rence rates are evident, none of these differences currence, and the occasional need for mesh re-
was statistically significant. moval with synthetic hernia repair in a contami-
Patients were also stratified by the type of su- nated surgical field, surgeons continue to search
ture used for the procedure, and outcomes were for other methods and materials to manage this
determined. Thirty-one percent (31.3%) of the pa- difficult dilemma [15, 16]. One such material that
tients who were repaired with absorbable sutures has garnered attention is HADM. Studies have
(n=32) developed a postoperative SSI, and 25% demonstrated that acellular grafts such as HADM
experienced hernia recurrence. Patients repaired have shown reduced postsurgical inflammation
with permanent sutures (n=38) had a slightly and rapid cellular infiltration and revasculariza-
higher SSI rate at 34.2%, but a lower rate of her- tion [17, 18]. This has been attributable to the

⊡ Table 14.6. Surgical repair technique and outcomes (WI wound infection; MM medical management; SM surgical
management; HR hernia recurrence)

Repair type n WI (%) MM (%) SM (%) HR (%)


14 Inlay 27 9 33.3 5 55.6 4 44.4 2 7.4

Onlay 15 1 6.7 1 6.7 0 0.0 2 13.3

Interpositional 23 10 43.5 3 30.0 7 70.0 7 30.4

Component separation 10 5 60.0 2 30 3 30.0 1 20.0

⊡ Table 14.7. Suture type and outcomes (WI wound infection; MM medical management; SM surgical management;
HR hernia recurrence)

Suture typea n WI (%) MM (%) SM (%) HR (%)

Absorbable (PDS) 32 10 31.3 7 70.0 3 30.0 8 25.0

Permanent (Prolene) 38 13 34.2 4 30.8 9 69.2 4 10.5


aSuture
type unknown in five cases
Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair
109 14
macroarchitecture of the HADM, which is native seromas from a pool of 16 ventral hernia patients
human dermis. The HADM is a three-dimensional in clean surgical settings [25]. Butler et al. evalu-
implant of tissue with an intact basement mem- ated the effectiveness of HADM in 13 suboptimal
brane, collagen fibers, elastin filaments, hyaluro- surgical patients in whom polypropylene mesh was
nan, and proteoglycans, as well as patent capillary contraindicated (perioperative radiation, place-
network channels [19]. Once HADM is vascular- ment of mesh directly over the bowel with bacte-
ized, the very nature of its structure allows it to rial contamination) [26]. Only two seromas (15%),
resist infection when implanted into the anterior one hematoma (8%), one occurrence of partial flap
abdominal wall. Animal models have also shown necrosis (8%), one case of enterocutaneous fistula
that HADM offers the same tensile strength as syn- formation (8%), and one case of wound dehiscence
thetic materials, while achieving superior revascu- (8%) were noted. This study demonstrates the use-
larization [20]. fulness of HADM in compromised surgical fields.
Our study substantiates the increasing amount Scott et al. have also explored the application of
of evidence demonstrating the utility of HADM HADM for open abdominal wound closure [27].
in ventral hernia repairs, especially in a com- HADM was used to definitively close 37 open ab-
promised surgical field. It is generally accepted domens that would not have otherwise closed pri-
that synthetic prostheses are contraindicated in a marily. The results were favorable: two SSIs (5.4%),
compromised surgical field because of unaccept- one intraabdominal abscess (2.7%), and no hernia
ably high rates of infection and hernia recurrence. recurrences.
However, no prospective trials have evaluated out- A prosthetic mesh infection is a complex sur-
comes between HADM and synthetic mesh re- gical problem. In most cases, this progresses to
pairs. Our results and those of others suggest that a chronic septic state, which usually mandates
ventral hernias repaired with HADM have accept- removal of the mesh. Under these circumstances,
ably low rates of infection and hernia recurrence immediate repair requires either autologous tis-
compared with those repaired with nonbiological sue material or a staged surgical repair. Yet these
prostheses. Voyles et al. reported nine polypropyl- cases have a universally high wound infection rate.
ene mesh removals out of 29 (31%) surgically con- In our study, we had a 33% wound infection rate,
taminated ventral hernia repairs due to infection but only five cases required removal of the AHD
or fistula formation [21]. Animal models have during the early experience. The revascularization
also shown high rates of polypropylene and poly- of the HADM coupled with early surgical manage-
tetrafluoroethylene mesh removal due to infection ment of complex surgical wound infections al-
[22, 23]. Geisler et al. reported hernia recurrence lowed us to salvage the repair. It became clear that
of 43% with synthetic mesh in compromised sur- a surgical wound infection did not always equal a
gical fields [24]. mesh infection.
The overall rates of wound infection (33.3%) The impact of hernia repair type on patient
and hernia recurrence (16%) in this study are con- outcomes demonstrates general agreement with
sistent with studies reporting complication rates the existing literature. Several studies have shown
for synthetic prostheses in compromised surgical that the interposition technique yields the highest
fields. Several previous studies also evaluated out- frequency of complications, whereas the inlay ap-
comes in hernia repair using HADM and demon- proach involves complications least frequently [28,
strated lower complication rates as well. Buinewicz 29]. Although no particular method was statisti-
and Rosen, in a retrospective review of 44 patients cally superior in our small patient population, the
who underwent incisional hernia repair or TRAM numbers strongly discourage the use of interpo-
flap surgery using HADM, reported a 7% postop- sitional hernia repair. The existing literature also
erative wound infection rate and 5% hernia recur- favors inlay (sublay) repair, but in our study, the
rence in clean surgical fields. No patient required onlay technique proved to be less prone to infec-
reoperation or removal of the HADM [10]. Kolker tion and just as resistant to hernia recurrence as
et al. reported no hernia recurrences and only two the inlay technique. Component separation repairs
110 Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair in the Compromised Surgical Field

also had a low rate of recurrence (10%) but a much References


higher rate of wound infection (50%). Again, the
size of our patient population did not allow for 1. Trupka AW, Schweiberer L, Hallfeldt K, Waldner H. Ma-
nagement of large abdominal wall hernias with for-
statistical significance, but the results favor either
eign implant materials (Gore-tex patch). Zentralbl Chir
inlay or onlay HADM placement. 1997;122:879–884
Repair of these complex ventral defects with 2. Bleichrodt RP, Simmermacher RKJ, Van der Lei B, Schaken-
onlay, inlay, or component separation surgical raad JM. Expanded polytetrafluoroethylene patch ver-
techniques commonly requires large adjacent skin sus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gyn Obst 1993;176:
flaps. This allows for mobilization of the skin and
18–24
primary closure of the surgical wound. This tech- 3. Voyles CR,Richardson JD, Bland KI, et al. Emergency ab-
nique results in large subcutaneous spaces that are dominal wall reconstruction with polypropylene mesh.
commonly managed with drains to allow egress Short term benefits versus long term complications. Ann
of collected fluid, with collapse of the space. In Surg 1981; 194:219–223
4. Temudom T, Siadati M, Sarr JG. Repair of complex giant or
our study, drains were universally used for this
recurrent ventral hernias by using tension-free intrapari-
purpose. White et al. [9] found that abnormal fluid etal prosthetic mesh (Stoppa technique): lessons learned
collections are the most frequent problem in these from our initial experience (fifty patients). Surgery 1996;
types of hernia repairs. However, the use of drains 120:738–744
does not reduce the incidence of complications 5. Finan KR, Vick CC, Kiefe CI, Neumayer L, Hawn MT. Predic-
tors of wound infection in ventral hernia repair. Am J Surg
such as wound infection or seroma formation.
2005;190(5):676–681
6. Scott BG, Feanny MA, Hirschberg A. Early definitive clo-
sure of the open abdomen: a quiet revolution. Scand J
Strengths and Limitations Surg 2005;94(1):9–14
7. Mayberry JC, Burgess EA, Goldman RK, et al. Enterocuta-
neous fistula and ventral hernia after absorbable mesh
This is the largest study to date using AHD in
prosthesis closure for trauma: the plain truth. J Trauma
a compromised surgical field, and it was con- 2004;57(1):157–162
ducted at a large academic referral center. This is 8. Houck JP, Rypins EB, Sarfeh IJ, et al. Repair of incisional
a retrospective review, with all the limitations and hernia. Surg Gynecol Obst 1989; 169:397–399
problems associated with such a study. We did 9. White TJ, Santos MC, Thompson JS. Factors affecting
wound complications in repair of ventral hernias. Am
not have a control arm, and the follow-up period
Surg 1998;64(3):276–280
was extremely limited. This was a heterogeneous 10. Buinewicz B, Rosen B. Acellular cadaveric dermis (acellular
population that included trauma, general surgery, human dermis): a new alternative for abdominal hernia
and emergency general surgery cases. As such, no repair. Ann Plast Surg 2004; 52:188
14 long-term analysis or conclusions can be gathered 11. Bauer JJ, Harris MT, Kreel I, et al. Twelve-year experience
with expanded polytetrafluoroethylene in the repair of
from the data. Future studies are required to di-
abdominal wall defects. Mt Sinai J Med 1999; 66: 20–25
rectly compare the use of acellular human dermis 12. Luijendijk RW, Hop WC, van den Tol MP, et al. A compari-
vs. prosthetic mesh regarding the long-term suc- son of suture repair with mesh repair for incisional hernia.
cess of ventral repair in a prospective fashion. N Engl J Med 2000; 343(6):392–398
13. Burger JW, Luijendijk RW, Hop WC, et al. Long-term
follow-up of a randomized controlled trial of suture ver-
sus mesh repair of incisional hernia. Ann Surg 2004;
Conclusion
240(4):578–583
14. The Hospital Infection Control Practices Advisory Com-
Our analysis demonstrates the value of AHD for mittee. Guidelines for prevention of surgical site infection.
repairing a ventral hernia in a compromised surgi- Am J Infect Control 1999; 27:109–110
15. Diaz JJ Jr, Gray BW, Dobson JM, et al. Repair of giant ab-
cal field. The relatively low rate of surgical wound
dominal hernias: does the type of prosthesis matter? Am
infection and hernia recurrence coupled with the Surg 2004;70(5):396–401; discussion 401–402
infrequent necessity for AHD removal favors its 16. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term com-
use over synthetic mesh for contaminated ventral plications associated with prosthetic repair of incisional
hernia closure [30]. hernias. Arch Surg 1998;133(4):378–382
Chapter 14 · Human Acellular Dermal Matrix for Ventral Hernia Repair
111 14
17. Livesey SA, Herndon DN, Hollyoak MA, et al. Transplanted
acellular allograft dermal matrix. Potential as a template
for the reconstruction of viable dermis. Transplantation
1995;60(1):1–9
18. Eppley BL. Experimental assessment of the revasculariza-
tion of acellular human dermis for soft-tissue augmenta-
tion. Plast Reconstr Surg 2000; 107:757
19. LifeCell. AlloDerm Regenerative Tissue Matrix. http://
www.lifecell.com/products/95/
20. Silverman RP, Singh NK, Li EN, et al. Restoring abdominal
wall integrity in contaminated tissue-deficient wounds
using autologous fascia grafts. Plast Reconstr Surg
2004;113(2):673–675
21. Voyles CR, Richardson JD, Bland KI, et al. Emergency ab-
dominal wall reconstruction with polypropylene mesh:
short-term benefits versus long-term complications. Ann
Surg 1981;194(2):219–223
22. Bleichrodt RP, Simmermacher RKJ, van der Lei B, et al.
Expanded polytetra-fluoroethylene patch versus polypro-
pylene mesh for the repair for contaminated defects of
the abdominal wall. Surg Gynecol Obstet 1993; 176:18
23. Brown GL, Richardson JD, Malangoni MA, et al. Compari-
son of prosthetic materials for abdominal wall reconstruc-
tion in the presence of contamination and infection. Ann
Surg 1985; 201:705
24. Geisler DJ, Reilly JC, Vaughan SG, Glennon EJ, Kondylis PD.
Safety and outcome of use of nonabsorbable mesh for
repair of fascial defect in the presence of open bowel. Dis
Colon Rectum 2003; 46(8):1118–1123
25. Kolker AR, Brown DJ, Redstone JS, Scarpinato VM, Wal-
lack MK. Multilayer reconstruction of abdominal wall
defects with acellular dermal allograft (acellular human
dermis) and component separation. Ann Plast Surg
2005;55(1):36–41; discussion 41–42
26. Butler CE, Langstein HN, Kronowitz SJ. Pelvic, abdominal
and chest wall reconstruction with acellular human der-
mis in patients at increased risk for mesh-related com-
plications. Plast Reconstr Surg. 2005;116(5):1263–1275;
discussion 1276–1277
27. Scott BG, Scott BG, Welsh FJ, et al. Early aggressive clo-
sure of the open abdomen–a new approach. J Trauma
2006;60(1):17–22
28. Ueno T, Pickett LC, de la Fuente SG, et al. Clinical ap-
plication of porcine small intestinal submucosa in the
management of infected or potentially contaminated ab-
dominal defects. J Gastrointest Surg 2004;8:109–112
29. de Vries Reilingh TS, van Geldere D, et al. Repair of
large midline incisional hernias with polypropylene
mesh: comparison of three operative techniques. Hernia
2004;8(1):56–59
30. Langer C, Liersch T, Kley C, Flosman M, et al. Twenty-five
years of experience in incisional hernia surgery. A compa-
rative retrospective study of 432 incisional hernia repairs.
Chirurg 2003;74(7):638–645
15

Fate of the Inguinal Hernia Following


Removal of Infected Prosthetic Mesh
A. S. Fawole, R. P. C. Chaparala, N. S. Ambrose
114 Chapter 15 · Fate of the Inguinal Hernia Following Removal of Infected Prosthetic Mesh

Introduction The aim of this study was to determine the


incidence of inguinal hernia recurrence follow-
Over 70,000 groin hernias are repaired each year in ing the removal of an infected prosthetic mesh.
England and Wales. Tension-free mesh hernioplasty In addition, the perioperative complications and
is a commonly performed procedure for repair of long-term symptoms associated with removal were
inguinal hernias. It is relatively easy to perform, reviewed.
with one of the lowest recurrence rates of the avail-
able repairs [1], and studies have shown that this is a
safe procedure with very few complications [2]. But Patients and Methods
there are concerns about infection because of the
introduction of a foreign material into the body. Over an 8-year period from January 1, 1995, to
Surgical site infection following inguinal her- December 31, 2002, 2,017 patients [1,892 male,
nia repair has been reported to be anything from 0 125 female; median age 60 (range 15–95) years]
to 15%. The majority of these are superficial infec- had repair of inguinal hernias in our university
tions and do not appear to be influenced by the teaching hospital. Of these, 122 patients had bilat-
presence of a mesh [3]. These usually settle sponta- eral hernias repaired, making a total of 2,139 in-
neously with the use of antibiotics and sometimes guinal hernias repaired in this study period; 1,955
require superficial incision and drainage. However, were primary inguinal hernias, and 184 procedures
deep wound infection is a serious complication were performed for a recurrent inguinal hernia.
leading to chronic groin sepsis, which requires A retrospective case note review of patients
removal of the prosthetic mesh material to allow who had mesh removal after inguinal hernia repair
resolution of the infective process. was undertaken. These notes were retrieved from
Taylor and O’Dwyer [4] identified 12 cases of records obtained from the operating theatre data-
chronic groin sepsis following mesh repair of an base system, which searched for all patients who
inguinal hernia in Scotland over a 4-year period, had mesh removal. All patients with groin sepsis
all of which required complete or partial removal requiring mesh removal were included; however,
of the mesh to resolve the sepsis. Follow-up data two patients had removal of mesh for chronic
were available for 11 of these 12 patients, two groin pain and were excluded. Patients were fur-
of whom developed hernia recurrence following ther followed up by a telephone interview and were
mesh removal, although the duration of follow-up subsequently reviewed in the surgical outpatient
was not stated for the rest of the patients. One of clinic by one of the authors (NSA) to determine
these patients, who developed a recurrence about the outcomes after mesh removal. The main out-
2 years after initial mesh removal, had a further come measures were incidence of hernia recur-
mesh repair that, unfortunately, once again led rence and chronic groin pain.
to groin sepsis requiring removal of the second
15 mesh to control the infection. The other patient
remained asymptomatic on follow-up, and the re- Results
currence was thus not treated surgically [4].
Case reports have not observed hernia recur- Fourteen patients [11 male, three female; median
rence following removal of infected mesh mate- age 60 (range 24–77) years] had mesh removal for
rial inserted by the open [5] or laparoscopic [6] chronic groin sepsis during this 8-year period.
techniques. A randomised controlled trial of pro- Only one of these patients had repair of a re-
phylactic antibiotics in mesh hernioplasties found current inguinal hernia as the initial procedure; all
four cases of deep infection in the overall popula- the others had repair of primary inguinal hernias.
tion of 280 patients studied (1.4%). Three of these One patient had repair of bilateral primary ingui-
required mesh removal for symptom control, and nal hernias, but there was evidence of infection on
all three had no evidence of hernia recurrence at one side, which resulted in removal of the mesh.
1 year follow-up [7]. An onlay polypropylene mesh was used in all of
Chapter 15 · Fate of the Inguinal Hernia Following Removal of Infected Prosthetic Mesh
115 15
the patients except one, who had only a polypro- appointment and were seen only after developing
pylene mesh plug repair. The mesh was secured deep infection.
with staples in five patients, and a polypropylene Infection was first noticed in the groin at a
suture was used in the remaining nine, including mean of 11 (range 1–35) months following hernia
the patient who had a mesh plug repair. repair (⊡ Table 15.1). There is no statistical differ-
Seven of these 14 patients had their initial ence between the mean times to first presentation
hernioplasty performed as a day-case procedure. of those patients who had prophylactic antibiotics
Six patients had a planned overnight stay. One (10 months) and those who did not (12.5 months);
patient had a delayed discharge (9 days) because p=0.33.
of a scrotal haematoma that was treated conser- All patients were initially treated conserva-
vatively. tively with repeated courses of antibiotics for a
Six of the 14 patients received a dose of pro- mean period of 10 (range 1–49) months.
phylactic antibiotic at the time of their operation Mesh removals were performed at a mean
(Table 15.1). There was no evidence of infection at of 22 (range 2–62) months following the initial
the time of discharge in any of these patients. hernia repair. All mesh removals were performed
Two patients developed deep wound infection under general anaesthetic, and there were no
at 1 month. Another four were routinely seen at perioperative complications. Eight patients had
about 2 months, and none of them had evidence specimens sent for bacteriology at the time of
of infection at that time. The remaining eight pa- operation, and six of these grew Staphylococcus
tients did not have a routine postoperative clinic aureus on culture.

⊡ Table 15.1. Use of prophylactic antibiotics, period of conservative management, and timing of operation in patients
who had mesh removal

Patient Prophylactic Duration between initial Period of conservative Duration between


antibiotics operation and first sign management with initial operation and
of infection (months) antibiotics (months) mesh removal (months)

1 Yes 1 4 5

2 None documented 3 3 6

3 None documented 28 1 29

4 Yes 13 49 62

5 None documented 35 9 44

6 None documented 9 25 36

7 None documented 7 1 8

8 None documented 4 26 30

9 Yes 8 3 11

10 None documented 13 4 17

11 Yes 7 10 17

12 Yes 25 4 29

13 Yes 6 6 12

14 None documented 1 1 2
116 Chapter 15 · Fate of the Inguinal Hernia Following Removal of Infected Prosthetic Mesh

All the patients who had mesh removal were guinal hernias [2, 4, 7], but it does usually require
followed up. After a median period of 44 (range removal of the mesh to facilitate cessation of the
5–91) months, there were two recurrences, which groin sepsis [4, 5, 9].
were both asymptomatic. One of these patients We have shown a deep infection rate of about
noticed a lump in the groin 5 months following 0.7% (14 out of 2,017 patients). This is higher than
mesh removal, but this was asymptomatic, and in some reports, 0.03% [2], but is comparable to
he elected to have this treated conservatively. He other studies that found deep infection rates of
was reviewed 10 months following recurrence and 1.4% [7] and even higher rates of superficial infec-
has remained asymptomatic. The other patient tion [10].
had a persistent minor groin discharge after mesh A wide range of surgeons with no particular
removal, which settled completely after 2 months. interest in hernia repair, including mostly surgical
He was reviewed in the clinic 41 months after trainees, performed the operations in this pres-
mesh removal and had remained asymptomatic, ent study. This heterogeneous group of operating
but clinical examination revealed a cough impulse surgeons may partly explain the relatively higher
suggestive of a small recurrent hernia. rate of deep infections compared with specialist
On questioning, none of the patients com- hernia repair centres. Inexperienced surgeons may
plained of pain or discomfort that interfered with excessively handle the mesh, which may contrib-
their usual level of activity. ute to development of deep infection. Although
contamination at the time of operation is the likely
source of infection in superficial infections, this
Discussion is unlikely to be the aetiology in deep infections,
which often present after a delayed period. These
Chronic groin sepsis is a dreaded complication of may be a result of haematogenous spread from
inguinal hernia repair using prosthetic material. distant sites [4].
Intuitively, prophylactic antibiotics would appear It has been suggested that conservative treat-
to be indicated in hernia repair with mesh, as this ment of groin infections with antibiotics leads to
procedure involves introducing a foreign body into resolution of infection [11]. This is a reasonable
the groin. However, the literature is certainly di- proposition when there is only superficial infec-
vided regarding the use of prophylactic antibiotics tion of the subcutaneous tissue, but deep infection
in mesh repair of inguinal hernias. A Cochrane persists until there is surgical extirpation of the
review of the literature [8] was unable to conclude infected prosthetic material. In our series, groin
a benefit for recommending antibiotic prophylaxis sepsis did not settle even with repeated prolonged
in elective primary inguinal hernia repair. A subse- courses of antibiotics in some of the patients.
quent update in 2007 came to the same conclusion Removal of infected prosthetic mesh is po-
but suggested that antibiotics could not be argued tentially associated with operative complications
15 against when high infection rates are detected. because of the concomitant inflammatory reaction
In this present series, the use of prophylactic that may make tissue planes more difficult to find.
antibiotics was documented in six out of 14 pa- Meticulous surgical technique is thus necessary
tients and did not appear to confer a benefit in to ensure careful dissection and prevent intraop-
preventing mesh infection. Deep infection tends erative damage to structures, especially within the
to present after a delayed period following mesh spermatic cord. In this study, no complications
repair of inguinal hernias; there was a mean pe- were associated with mesh removal. All mesh re-
riod of 10 months’ delay in this group of patients. movals were performed by a consultant surgeon or
Use of prophylactic antibiotics does not appear to a senior surgical trainee under the direct supervi-
alter the time to presentation with deep infection sion of the consultant. For most of the patients
(p=0.33). (12 out of 14), there were no attempts to reinforce
Available reports suggest that deep wound in- the transversalis fascia, which was thickened and
fection is uncommon following mesh repair of in- fibrosed even after mesh removal. Two patients
Chapter 15 · Fate of the Inguinal Hernia Following Removal of Infected Prosthetic Mesh
117 15
had loose plication of the fascia with interrupted 5. Ismail W, Agrawal A, Zia MI. (2002) Fate of chronically
absorbable polydioxanone sutures. infected onlay mesh in groin wound. Hernia 6:79–81
6. Avtan L, Avci C, Bulut T, Fourtanier G. (1997) Mesh infec-
After a median follow-up period of 44
tions after laparoscopic inguinal hernia repair. Surg Lap-
(5–91) months, only two of the 14 patients who arosc Endosc 7:192–195
had mesh removal for deep infection had devel- 7. Yerdel MA, Akin EB, Dolalan S, Turkcapar AG, Pehlivan M,
oped hernia recurrence. These cases remained as- Gecim IE, Kuterdem E. (2001) Effect of single-dose pro-
ymptomatic and were thus treated conservatively. phylactic ampicillin and sulbactam on wound infection
after tension-free inguinal hernia repair with polypropyl-
Deep-seated wound infection has also been
ene mesh: the randomized, double-blind, prospective
reported following laparoscopic hernia repair and trial. Ann Surg 233:26–33
also requires removal of the mesh, which can be 8. Sanchez-Manuel FJ, Seco-Gil JL. (2003) Antibiotic pro-
done laparoscopically or by an open technique. phylaxis for hernia repair. Cochrane Database Syst
Even after laparoscopic surgery, mesh removal Rev:CD003769
9. Hatada T, Ishii H, Ichii S, Ashida H, Yamamura T. (2000)
does not appear to lead to hernia recurrence [6].
Late infection after mesh-plug inguinal hernioplasty. Am
In conclusion, deep-seated wound infection J Surg 179:76–77
following inguinal hernia repair is uncommon. 10. Taylor EW, Duffy K, Lee K, Hill R, Noone A, Macintyre I,
When it does occur, it results in chronic groin sep- King PM, O’Dwyer PJ. (2004) Surgical site infection after
sis, which in the majority of cases requires removal groin hernia repair. Br J Surg 91:105–111
11. Gilbert AI, Felton LL. (1993) Infection in inguinal her-
of the infected material before symptoms resolve.
nia repair considering biomaterials and antibiotics. Surg
However, hernia recurrence is not inevitable, sug- Gynecol Obstet 177:126–130
gesting that the strength of a mesh repair lies in the
fibrous reaction evoked within the transversalis
fascia by the prosthetic material rather than in the
physical presence of the mesh itself. Discussion
With careful dissection, an infected mesh can
be removed without any associated complications. Jacob: Concerning infection after groin hernia
Therefore, in established deep infection, physi- repair, have you looked at those patients who have
cians should not hesitate to remove an infected a local anesthetic compared to those who have
mesh to allow resolution of chronic groin sepsis. general anesthesia?
Patients should be warned that they may develop Fawole: We haven’t looked at this special point.
a recurrence. We would advise repairing this by a But you are right; there might be a risk for bring-
posterior (laparoscopic) approach after removal of ing bacteria into the tissue during the local anes-
mesh following an anterior (open) mesh hernio- thesia.
plasty.

References

1. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM.


(1989) The tension-free hernioplasty. Am J Surg 157:188–
193
2. Shulman AG, Amid PK, Lichtenstein IL. (1992) The safety
of mesh repair for primary inguinal hernias: results of
3,019 operations from five diverse surgical sources. Am
Surg 58:255–257
3. Mann DV, Prout J, Havranek E, Gould S, Darzi A. (1998)
Late-onset deep prosthetic infection following mesh re-
pair of inguinal hernia. Am J Surg 176:12–14
4. Taylor SG, O’Dwyer PJ. (1999) Chronic groin sepsis follow-
ing tension-free inguinal hernioplasty. Br J Surg 86:562–
565
16

Mesh Infection–Therapeutic Options


E. Schippers
120 Chapter 16 · Mesh Infection–Therapeutic Options

Introduction ted fabric, which consists of a series of loops with


no interlocking knots that might harbor serum
The use of meshes in hernia repair has become and bacteria. With increasing recognition of the
standard procedure throughout the world. Im- value of biomaterials for the repair of abdomi-
plantation of a mesh has been found to reduce nal wall hernias, knowledge of biomaterial-related
the rate of recurrence in the repair of incisional complications required in-depth knowledge and
hernias [1–3]. However, mesh-related complica- understanding of the physical properties of the
tions have become increasingly important. Pos- prostheses. Consequently, Amid [9] proposed a
therniorrhaphy mesh infection, mesh bowel in- classification of available biomaterials for hernia
trusion, fistula formation, and eventual removal surgery based on their pore size:
and reinsertion have been induced by mesh con- Type I: Totally macroporous prostheses con-
tamination during primary surgery. Mesh-related taining pores larger than 75 μm, a pore size that
infections following surgery occur relatively in- is required for admission of macrophages, fibro-
frequently compared with other device-related blasts, blood vessels, and collagen fibers into the
infections; an incidence of mesh-related infec- pores
tions after incisional hernia repair up to 8% has Type II: Totally microporous prostheses; these
been reported [4]. prostheses contain pores that are less than 10 μm
The relevance of bacterial contamination is in at least one of their three dimensions
controversial in the literature, although it is of Type III: Macroporous prostheses with multi-
considerable clinical importance to the patient filamentous or microporous components, braided
and surgeon. Deysine describes mesh infection polypropylene mesh, or braided Dacron mesh
with consecutive migration and fistula formation Surgical infection promoted by implantation
as a catastrophe [5]. In vascular surgery, even of biomaterials is caused by infection and pro-
more dramatic consequences of infected prosthe- liferation of bacteria into and within the pores
ses, including a mortality rate of 75%, were re- and interstices of these synthetic materials. When
ported in earlier times. Patients with an infected pores are less than 10 μm, bacteria averaging 1 μm
prosthesis would ultimately die from massive cannot be eliminated by macrophages and neutro-
hemorrhage or septicemia unless the prosthesis philic granulocytes, which are too large to enter a
was removed [6]. However, in renal transplant 10-μm three- dimensional pore. Type I prostheses
recipients with immunosuppression and comor- deter housing and growth of bacteria by allowing
bidities such as obesity, diabetes, and chronic macrophages, rapid fibroplasia, and angiogenesis,
pulmonary diseases, surgical repair of infected which also prevents infiltration and growth of
or contaminated herniation with polypropylene bacteria. Types II and III prostheses are similar to
mesh is safe and effective and yields excellent braided suture materials, and by harboring bacte-
results [7]. ria, they can promote their growth, likewise result-
ing in biomaterial-related infection.
With respect to this classification and to the
16 Type of Mesh biomaterial-related complications, Amid con-
cluded that in cases of infection, the totally ma-
Shortly after introducing polyethylene mesh for croporous prostheses (type I) do not have to be
replacing tissue defects, Usher [8] underscored the removed. To manage the infection, drainage and
relevance of mechanical and biological proper- local wound care are all that is necessary. In cases
ties of the mesh that are associated with the type of infection with type II or III mesh, total removal
of tissue structure. In experiments with infected (II) or partial removal of type III is required.
wounds in dogs, he demonstrated that knitted Leber et al. [10] analyzed the long-term com-
material and taffeta weave were equally inert to plications associated with prosthetic repair of in-
infection. He attributed this in part to the use of cisional hernia. They found that late infections
a monofilament and to the structure of the knit- appearing months or even years after surgery were
Chapter 16 · Mesh Infection–Therapeutic Options
121 16
more challenging. These were often combined with isms associated with cases of mesh infections
complex fistulas involving bowel, and the mesh are Staphylococcus spp., especially Staphylococcus
had to be removed. In their study, multifilamented aureus; Streptococcus spp.; gram-negative bacteria
polyester mesh was associated with a significantly (mainly Enterobacteriaceae); and anaerobic bac-
greater number of infections. teria [14]. The reported high rate of 63% of me-
Based on this clinical observation, the influ- thicillin-resistant Staphylococcus aureus (MRSA)
ence of the presence of either a monofilament complicating intraperitoneal mesh implantation
or multifilament mesh material on the bacterial is alarming [4].
infection risk was studied in a rat model [11]. The
extent of adherent bacteria corresponded to the
estimated filament surface, thus favoring the use of Diagnosis
monofilament materials.
Robinson et al. reviewed medical device re- Patients usually present with symptoms and signs
ports from the U.S. Food and Drug Administra- of local acute inflammation: pain, erythema, in-
tion on the use of surgical mesh for hernia repair. creased temperature, and tenderness and swelling
The analysis of 252 reports revealed a percentage in the abdominal wall in the area of the mesh. Sys-
of 42% related to infection. Polytetrafluoroeth- temic manifestations include fever, malaise, and
ylene (PTFE) mesh especially tended to be as- chills or rigor. Abdominal abscesses and discharg-
sociated with more infections. Another conclu- ing fistulas can be the first clinical manifestation.
sion was that cases of polypropylene infections To monitor prosthetic infections, erythrocyte
can be healed without mandatory removal of the sedimentation rate (ESR), C-reactive protein, and
mesh [12]. white blood cell count are well-established labora-
tory methods. White blood cell counts have a sen-
sitivity of only 20% and a predictive value of 50%.
Role of Bacteria The combination of ESR and C-reactive protein is
a more powerful diagnostic tool; when both are
Deysine [13] categorized meshes into two groups: negative, the possibility of infection is zero. When
those that are hydrophobic, such as expanded both are positive, the possibility of infection is
PTFE, and those that are hydrophobic, includ- 83% [15].
ing polyester and polypropylene. Those repelling
water take more time to become integrated by
the fibroblastic response. Likewise, hydrophobic Imaging
materials may initially repel the fluids containing
bacteria. The role of bacteria in cases of rejection With the help of ultrasound, a noninvasive pro-
was described as follows: cedure, most mesh-related complications can be
Prostheses are rejected through the process detected or ruled out. An abscess formation is seen
of suppuration after becoming colonized by bac- as a hypoechogenic structure caused by cell debris,
teria [5]. In order to adhere, bacteria undergo with small plump hyperechoic reflections caused
functional changes such as the production of by gas bubbles. The extent of incomplete fistulas
slime, which enhances an irreversible and strong within the abdominal wall can be determined. The
adhesion. Slime production is a major pathogenic hypoechoic structure of the fistula channel can be
property of bacterial strains that form biofilms on followed through the abdominal wall (⊡ Fig. 16.1).
surfaces. Once the microorganisms have adhered Computed tomography and magnetic resonance
to a biomaterial’s surface, they are protected imaging allow clear identification of abdominal
against phagocytosis because the microorganisms wall pathologies. Indications for these are sono-
and biomaterials together are too large to ingest. graphically uncertain results; however, the disad-
Although a variety of different bacteria can cause vantages include higher costs, limited availability,
a prosthetic infection, the usual causative organ- and the danger of contrast medium allergy. Fistu-
122 Chapter 16 · Mesh Infection–Therapeutic Options

Antibiotics

Bacterial susceptibility to pharmacological treat-


ment is significantly reduced when a polymeric
device is present. Possible reasons for the reduced
susceptibility of biofilm-embedded organisms to
antibiotic agents include a slow rate of bacterial
growth within the biofilm, inhibition of antimicro-
bial activity by biofilm substances, and poor pen-
etration of the biofilm by antibiotics [19]. There-
fore, the strategy of monotherapy with intravenous
antibiotics in cases of mesh-related infections has
⊡ Fig. 16.1. Typical sonographic finding of an abscess formati- a poor outcome and consequently has no indica-
on and fistula channel with hypoechoic structures tion [14].

lography reveals the extent, location, and relation Open Wound Treatment
of fistulas and is therefore a helpful tool in preop-
erative planning. Standard surgical practice supports removing pros-
thetic material when a wound infection involves
the prosthesis. The removal of mesh in this situa-
Treatment tion is often technically difficult and may result in
substantial additional complications. Local tissue
Therapeutic options in cases of mesh infection range incorporation can make removal of mesh danger-
from prevention and intravenous antibiotics to open ous because adjacent vascular structures or the
wound treatment and mesh removal. The essential bowel can be injured, which may result in acute
factor in the evolution and persistence of infection bleeding or subsequent development of an entero-
is the formation of a biofilm around the implanted cutaneous fistula. Because achieving closure of the
device [16]. The biofilm is capable of resisting anti- fascial defect after mesh removal is usually not
microbial agents due to the protective mechanism. possible, this surgery may result in an incisional
Adequate prevention of a biomaterial-centered in- hernia that is larger than the original one.
fection is therefore aimed at the first contact of a In early postoperative infections after implan-
microorganism with a biomaterial. Bacterial adhe- tation of porous mesh, it is therefore advised to
sions on the biomaterial depend on the material introduce an open wound management strategy
surface. Mesh coated with different precious metals, combined with a suction-based debridement sys-
such as titanium, silver, or gold, can successfully re- tem as an alternative to explantation of the mesh.
duce bacterial attachment [17]. Because ultrasound The principle of vacuum sealing has been intro-
16 reduces biofilm formation, several studies on the duced for the treatment of complicated wounds
effect of ultrasound on bacterial cell growth and [20]. The first step is wound opening, followed by
on the treatment of biomaterial-centered infections necrosectomy, wound debridement, and irrigation.
have been performed. A positive effect of ultra- A polyvinyl vacuum foam is cut to size and placed
sound in addition to treatment with antibiotics has into the wound. A vacuum-assisted closure system
been shown. Theoretically, a phenomenon called with transparent polyurethane foil is applied to the
the bioacoustic effect enhances the transportation open portion of the wound and skin (⊡ Fig. 16.2).
and penetration of antibiotics within the biofilms. Permanent suction at 60–80 kPa must be estab-
The contribution of low-frequency and high-inten- lished. The foam is removed at 2–5-day intervals,
sity ultrasound in the presence of an antibiotic agent with the transparent foil allowing daily inspection
removes and kills microorganisms [18]. of the wound. This treatment results in progressive
Chapter 16 · Mesh Infection–Therapeutic Options
123 16

⊡ Fig. 16.3. Example of a microporous mesh followed by late


infection and fistula that had to be removed

primarily implanted. With respect to prevention


and therapy, the ideal mesh is macroporous, hy-
drophilic, and monofilamented. Two-thirds of in-
b fections are caused by Staphylococcus spp., and
methicillin-resistant staphylococci are frequent.
⊡ Fig. 16.2. Steps in vacuum sealing after early mesh infec- The therapeutic options are both mesh-related and
tion. a Cutting the foam to size. b Vacuum-assisted closure time-related. Open wound treatment, including
system in place vacuum sealing, is indicated in early postoperative
infection of macroporous meshes. Explantation
should be limited to microporous meshes or late
debridement and granulation of the open wound and chronic infections, which are often compli-
and causes a dermatotraction with approximation cated by sinus or fistula formation. Monotherapy
of the wound edges. After successful wound condi- with antibiotics should be abandoned. Interesting
tioning, a secondary closure of skin over the mesh aspects for future research in this field include
can be achieved without mesh removal. biofilm formation, bioacoustic effects, and mesh
However, mesh explantation is recommended coatings.
for all type II prostheses (totally microporous) [9].
Furthermore, later infections after months or even
years are more challenging and also require re- References
moval of the prosthesis [21]. They are often com-
bined with complex fistulas involving the bowel. 1. Luijendijk RW, Hop WC, van den Tol MP, et al. (2000) A
In these cases, preservation of the mesh is likely comparison of suture repair with mesh repair for incisio-
nal hernia. N Engl J Med 343:392–398
to fail, and sooner or later the mesh has to be re-
2. Schumpelick V, Klosterhalfen B, Müller M, et al. (1999)
moved [22] (⊡ Fig. 16.3). Minimierte Polypropylen Netze zur präperitonealen Netz-
plastik (PNP): eine prospektive randomisierte klinische
Studie. Chirurg 70:422–430
Conclusion 3. Schippers E, Harsányi A, Thumbs A, Schneider M (2001)
Ergebnisse nach offener Netzplastik der Narbenhernie in
Sublay-Technik. Viszeralchirurgie 36:152–156
Mesh infection is a serious, but not catastrophic, 4. Copp WS IV, Harris JB, Lokey JS, McGill ES, Klove KL (2003)
complication in hernia surgery. The extent of the Incisional herniorrhaphy with intraperitoneal composite
damage correlates with the type of mesh that was mesh: a report of 95 cases. In: Proceedings of the Sou-
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theastern Surgical Congress, 7–11 February 2003, Savan- north AN, et al. (eds) Incisional hernia. Springer, Berlin, pp
nah, Georgia. Vol 69, pp. 784–787 217–227
5. Deysine M (2004) The catastrophe: mesh infection and 22. Klinge U, Conze J, Krones CJ, Schumpelick V (2005) Incisio-
migration with fistula formation–life-long risk? In: Schum- nal hernia: open techniques. World J Surg 29:1066–1072
pelick V, Neuhaus LM (eds) Meshes: benefits and risks.
Springer, Berlin, pp 207–227
6. Fry WJ, Lindenauer SM, Arbor A (1967) Infection com-
plicating the use of plastic arterial implants. Arch Surg
94:600–609
7. Antonopoulos IM, Nahas WC, Mazzucchi E, Piovesan AC,
Birolini C, Lucon AM (2005) Is polypropylene mesh safe
and effective for repairing infected incisional hernia in
renal transplant recipients? Urology 66:874–877
8. Usher FC (1961) Knitted Marlex mesh: an improved marlex
prosthesis for repairing hernias and other tissue defects.
Arch Surg 82:153–155
9. Amid PK (1997) Classification of biomaterials and their
related complications in abdominal wall hernia surgery.
Hernia 1:15–21
10. Leber GE, Garb JL, Alexander AI, Reed WP (1998) Long-
term complications associated with prosthetic repar of
incisional hernias. Arch Surg 133:378–382
11. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen
B, Schumpelick V (2002) Do multifilament alloplastic
meshes increase the infection rate? Analyses of the po-
lymeric surface, the bacteria adherence and the in vivo
consequences in a rat model. J Biomed Materials Res
63:765–771
12. Robinson TN, Clarke JH, Schoen J, Walsh MD (2005) Ma-
jor mesh-related complications following hernia repair:
events reported to the Food and Drug Administration.
Surg Endosc 19:1556–1560
13. Deysine M (1998) Management of prosthetic infections in
hernia surgery. Surg Clin North Am 78:1105–1115
14. Falagas A, Kasiakou SK (2004) Mesh-related infections
after hernia repair surgery. European Society of Clinical
Microbiology and Infectious Diseases, CMI, 11:3–8
15. Salvati EA, Callaghan JJ, Brause BD, et al. (1986) Reimplan-
tation in infection. Elution of gentamicin from cement
and beads. Clin Orthop Rel Res 207:83–93
16. Costerton JW, Stewart PS, Greenberg EP (1999) Bacterial
biofilms: a common cause of persistent infections. Sci-
ence; 284:1318–1322
17. Engelsmann AF, van der Mei HC, Ploeg RJ, Busscher HJ
16 (2007) The phenomenon of infection with abdominal wall
reconstruction. Biomaterials 28:2314–2327
18. Johnson LL, Peterson RV, Pitt WG (1998) Treatment of
bacterial biofilms on polymeric biomaterials using anti-
biotics and ultrasound. J Biomater Sci Polym Ed 9:1177–
1185
19. Darouiche R (2004) Treatment of infections associated
with surgical implants. N Engl J Med 350:1422–1429
20. Fleischmann W, Bacher U, Bischoff M, Hoekstra H (1995)
Vacuum sealing: indication, technique and results. Eur J
Orthop Surg Traumatol 5:37–40
21. Flament JB, Avisse C, Palot JP, Delattre JF (1999) Biomate-
rials–principles of implantation. In: Schumpelick V, Kings-
17

Does Antibiotic Prophylaxis Prevent


the Occurrence of Wound Infection
After Groin Hernia Surgery?
T. J. Aufenacker
126 Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection After Groin Hernia Surgery?

Introduction care. Conversely, discarding the use of antibiotic


prophylaxis in hernia repair could reduce costs,
A mesh-based repair is, in many Western coun- the risks of toxic and allergic side effects, and the
tries, the most popular technique for repairing possible development of bacterial resistance [13]
abdominal wall hernia in order to reduce the risk or superinfections.
of recurrence [1–7]. More than 80% of adult ab- To assess whether systemic antibiotic prophy-
dominal wall hernias occur in the groin, and in laxis prevents wound infection in groin hernia
the Western world the majority are being repaired repair, a systematic review and a meta-analysis of
with the use of a prosthetic mesh. There is a large randomised controlled trials were carried out.
variation in techniques used to correct a groin
hernia, with an even larger variety of meshes. Cur-
rently the most popular inguinal hernia technique Material and Methods
is the Lichtenstein hernia repair [8], using a flat
mesh to reinforce the inguinal wall. A search of Medline, EMBASE, CINAHL, DARE,
The incidence of infection after inguinal her- ACP, LILACS, and the Cochrane Register using
nia repair has been reported to vary from 0% to the terms hernia and antibiotic prophylaxis was
9% [9]. Especially when a foreign body, such as a done to identify randomised controlled trials on
polypropylene mesh, is used, prevention of a deep the subject published between 1966 and May
infection is of paramount importance because a 2008. All languages were considered. The search
deep infection of a mesh may require its removal, was performed independently by two reviewers,
as reported in several cases [10]. who selected potentially relevant papers based on
A Cochrane Review meta-analysis for inguinal title and abstract. References from the selected
hernia [11] in 2004 concluded that »antibiotic pro- papers were used for search completion. Field
phylaxis for elective inguinal hernia repair cannot experts were contacted for potential data, and
be firmly recommended or discarded« because the books of the abstracts from leading hernia meet-
number of included patients was limited and that ings over the last 8 years were manually checked
»further studies are needed, particularly on the use for unpublished data. All randomised placebo-
of mesh repair.« controlled trials using antibiotic prophylaxis in
Although most studies, as discussed later in mesh abdominal wall hernia repair with explicit
this chapter, do not support the use of antibiotic defined wound infection criteria and a minimum
prophylaxis, its use is still widespread. The reason follow-up period of 1 month were included. Each
for this might be legislative in many cases since paper was reviewed independently by three re-
an American attorney, for instance, could ask a viewers, and a quality assessment was performed
so-called expert during a court of law about a according to the scoring system of Jadad et al.
lack of antibiotic prophylaxis. In some cases, this [14]. Discrepancies among the reviewers were
expert might well be a psychiatrist without up- resolved by consensus. Only papers with a Jadad
dated knowledge in this area, and his or her advice score ≥3 were considered appropriate for further
would be misleading to those hearing the case. analysis.
Many American surgeons admit to continuing to Data were extracted from the studies and
17 use antibiotic prophylaxis for this reason. pooled using the Review Manager software [15]
Both in the United States and Europe, over 1.5 from the Cochrane Collaboration. A χ2 test for
million abdominal wall hernia repairs (of which heterogeneity of study results was performed. If
70% are groin hernia repairs) are performed an- heterogeneity could not be detected, data were
nually [12]. Therefore, any improvement in their pooled using a random effects model to correct
treatment could have a large medical and eco- for clinical diversity and methodological varia-
nomic impact. A reduction in the number of tions between studies. The effectiveness of antibi-
wound infections would especially have a great ef- otic prophylaxis to prevent wound infection was
fect on patient satisfaction, sick leave, and wound expressed as odds ratios (ORs) for dichotomous
Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection
127 17
data and their 95% confidence intervals (CIs). (⊡ Table 17.1) are used to perform an analysis with
Numbers needed to treat (NNT) and 95% CIs were the random-effect model. A nonsignificant effect
calculated from the OR and the background risk of antibiotic prophylaxis in nonmesh techniques
of wound infection for the patients in the placebo was demonstrated, OR 0.75 (0.53–1.06), NNT 85
groups. No subgroup analysis was performed. If it (45–359).
remained unclear from a study whether data were Regarding the mesh-based techniques, a sum-
presented for patients or hernias, a sensitivity anal- mary of the nine papers that included randomised
ysis (worst-case scenario) was done by varying the trials and the outcome of the assessment is given
distribution of bilateral hernia between the treated in ⊡ Table 17.2. The results of the three assessments
and placebo groups. did not differ among the three reviewers. The only
laparoscopic study, by Schwetling and Barlehner
[16], used an incorrect randomisation method and
Results lacked a definition of wound infection, but in the
absence of more studies on this technique, it was
The search resulted in a large number of poten- considered best evidence.
tially relevant studies, identifying nine papers re- Eight studies were, after the quality assessment,
porting prospective randomised data on the use of suited for meta-analysis regarding the use of anti-
antibiotic prophylaxis in groin hernia surgery with biotic prophylaxis in mesh-based repairs. They in-
prosthetic reinforcement. cluded 2,963 open inguinal and 43 femoral hernia
After the Cochrane meta-analysis update in repairs. The patient and surgical characteristics of
2007, no additional trials in the area of nonmesh these eight randomised controlled trials are docu-
repairs were published. In this Cochrane analysis, mented in ⊡ Table 17.3.
one study combining three trials with unpublished The included studies are presented separately
data is included. Therefore, the data regarding non- with their main intervention and results in ⊡ Ta-
mesh techniques from the Cochrane meta-analysis ble 17.4.

⊡ Table 17.1. Pooled data of six studies on the use of antibiotic prophylaxis for prevention of wound infection after non-
mesh inguinal hernia repair
Review: The effectiveness of antibiotic prophylaxis in inguinal hernia repair
Comparison: 01 Antibiotic prophylaxis vs: placebo
Outcome: 03 Non mesh techniques

Study or Antibiotic Placebo OR (random) Weight OR (random) Year


sub-category n/N n/N 95% Cl % 95% Cl

Evans 1/48 2/49 2.01 0.50 [0.04, 5.70] 1973

Anderson 5/137 6/150 8.14 0.91 [0.27, 3.05] 1980

Platt 4/301 6/311 7.33 0.68 [0.19, 2.45] 1990

Lazorthes 0/155 7/153 1.45 0.06 [0.00, 1.11] 1992

Taylor 25/283 25/280 35.35 0.99 [0.55, 1.77] 1997

Pessaux 68/2008 20/394 45.72 0.66 [0.39, 1.09] 2006

Total (95% Cl) 2932 1337 100.00 0.75 [0.53, 1.06]

Total events: 103 (Antibiotic), 66 (Placebo) 0.1 0.2 0.5 1 2 5 10


Favours treatment Favours control
Test for heterogeneity: Chi2= 4.31, df = 5 (P= 0.51), I2 = 0%
Test of overall effect: Z= 1.63 (P=0.10)
128 Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection After Groin Hernia Surgery?

⊡ Table 17.2. Results and quality of prospective randomised studies on the use of antibiotic prophylaxis in the prevention
of wound infection after mesh groin hernia repair

Reference Jadad Number Infec- Correct ran- Double- Wound Follow-up Accepted
score of tion domisation? blind? infection period? in meta-
patients % definition? analysis?

Laparoscopic inguinal hernia mesh repair (transabdominal preperitoneal)

Schwetling 0 80 0.0% No, alter- No No Un- No; best


[16] 1998 nately definition known evidence

Open inguinal and femoral hernia mesh repair

Morales [17] 4 524 1.9% Yes Yes Yes 1 year Yes


2000

Yerdel [18] 5 269 4.8% Yes Yes CDC criteria 1 year Yes
2001 [25]

Celdran [19] 4 91 4.4 % Yes Yes CDC criteria 2 years Yes


2004 [25]

Oteiza [20] 3 247 0.4% Yes No CDC criteria 1 month Yes


2004 [25]

Aufenacker 5 1,008 1.7 % Yes Yes CDC criteria 3 months Yes


[21] [25]
2004

Perez [22] 5 360 3.1% Yes Yes CDC criteria 1 month Yes
2005 [25]

Tovaras23 5 379 3,7% Yes Yes Yes 1 month Yes


2007

Jain24 5 120 1.7% Yes Yes CDC crite- 1 month Yes


2008 ria25

The total number of infections after groin prophylaxis group (0.3%), with an OR of 0.50 (95%
hernia repair with a mesh-based technique was CI 0.12–2.09) and an NNT of 352 (199–1961).
48/1,526 patients (3.1%) in the placebo group and The pooled data of six studies (the Morales and
24/1,480 patients (1.6%) in the antibiotic group. Tzovaras data were not available) are presented in
The pooled data for the eight studies are presented ⊡ Table 17.6.
in ⊡ Table 17.5. There was no statistical heteroge-
neity (p=0.36). The OR for wound infection after
antibiotic prophylaxis was 0.59 (95% CI 0.34–1.03), Discussion
17 resulting in an NNT of 80 (49–1111). A sensitivity
analysis was performed because the Celdran study In this systematic review and meta-analysis on
[19] did not specify in which group the eight bilat- the effectiveness of antibiotic prophylaxis in groin
eral hernias were included (worst-case scenario: in- hernia repair, the six randomised controlled trials
fection rate in Celdran’s placebo group 4/41=9.8%), concerning non-mesh-based techniques and the
resulting in an OR of 0.57 (95% CI 0.32–1.04). nine mesh-based trials demonstrate no significant
The number of deep infections after inguinal benefit of antibiotic prophylaxis.
and femoral hernia repair was 6/1,050 in the pla- For groin hernias, the wound infection rate re-
cebo group (0.6%) and 3/1,053 in the antibiotic ported in randomised controlled trials of 2.4% after
Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection
129 17

⊡ Table 17.3. Patient and study characteristics of eight randomised controlled trials on antibiotic prophylaxis in inguinal and
femoral hernia mesh repair (PHS Prolene Hernia System)

Morales Yerdel [18] Celdran Oteiza [20] Aufenacker Perez Tzovaras Jain [24]
[17] N=269a [19] N=247a [21] [22] [23] N=120a
N=524a N=99b N=1,008a N=360a N=379a

Total 1.9% 4.8% 4.4% 0.4% 1.7% 3.1% 3.7% 1.7%


infections (%)

Deep 0.8% 1.5% 0% 0% 0.3% 0.6% Not docu- 0%


infection (%) mented

Mesh 0.8% 1.1% 0% 0% 0.2% 0.6% 0% 0%


removal (%)

Body mass Not docu- 25.0 26.2 Not docu- Not docu- Not 26.0 Not docu-
index (mean) mented mented mented docu- mented
mented

Diabetes Not docu- Study 18 (18.1%) Not docu- Study Not 13 (3.4%) Study
mented exclusion mented exclusion docu- exclusion
criterion criterion mented criterion

Recurrent 39 (7.4%) Study 13 (13.1%) Study exclu- Study Study Not Study
hernia exclusion sion criterion exclusion exclusion docu- exclusion
criterion criterion criterion mented criterion

Duration of 34 min 63 min 65 min 40 min 40 min 53 min 45 min 58 min


surgery

Surgeons (%) 524 (100%) 0 (0%) 75 (75.8%) 247 (100%) 571 (56.6%) Not Not docu- 120 (100%)
Residents (%) 0 (0%) 269 (100%) 24 (24.2%) 0 (0%) 437 (43.4%) docu- mented 0 (0%)
mented

Bilateral Study exclu- Study Study ex- Study


hernia 0 (0%) 0 (0%) 8 (8.8%) sion criterion 56 (5.6%) exclusion clusion exclusion
criterion criterion criterion

Femoral Study Study ex- Study Study Study ex- Study


hernia 23 (4.4%) exclusion clusion 20 (8.1%) exclusion exclusion clusion exclusion
criterion criterion criterion criterion criterion criterion

Use of drains Study 60 (22.3%) Not docu- Not docu- 15 (1.5%) 0 (0%) 15 (4.0%) 0 (0%)
exclusion mented mented
criterion

Local Not docu- 111 (41.3%) 99 (100%) 226 (91.5%) 17 (1.7%) 0 (0%) 329 Not docu-
anaesthetics mented (86.8%) mented

Day 51 (9.7%) Not docu- 99 (100%) 247 (100%) 463 (45.9%) Not Not docu- 0 (0%)
surgery mented docu- mented
mented

Mesh type Flat, poly- Flat, poly- Flat, poly- Flat, poly- Flat, poly- Flat, Flat, poly- PHS, poly-
propylene propylene propylene propylene propylene polypro- propylene propylene
pylene

Exclusion bias 30/554 11/280 0/91 3/250 (1.2%) 7/1,015 0/360 2/381 0/120 (0%)
[26] (5.4) (3.9%) (0%) (0.7%) (0%) (0.5%)
aN= number of patients
bN= number of hernias (91 patients)
130 Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection After Groin Hernia Surgery?

⊡ Table 17.4. Results of individual studies accepted in the systematic review on the use of antibiotic prophylaxis for
preventing wound infection after mesh groin hernia repair (NNT number needed to treat)

Reference N Mean Males Type of Infection Infection interven- p-value NNT


age (%) antibiotic placebo group tion group
(years) (patients, %) (patients, %)

Laparoscopic inguinal hernia mesh repair (transabdominal preperitoneal)

Schwetling 80 55 86 Cefuroxime 0/40 0% 0/40 0% 1.0 ∞


[16] 1.5 g

Open inguinal and femoral hernia mesh repair

Morales [17] 524 54 90 Cefazolin 6/287 2.1% 4/237 1.7% 0.737 248
2g

Yerdel [18] 269 56 93 Ampicillin + 12/133 9.0% 1/136 0.7% 0.002 13


sulbactam
1.5 g

Celdran [19] 91 58 90 Cefazolin 4/49a 8.2% 0/50a 0.0% 0.059 13


1g

Oteiza [20] 247 57 85 Amoxicillin 0/123 0.0% 1/124 0.8% 0.318 NNH
+ clavulanic 124
acid 2 g

Aufenacker 1,008 58 96 Cefuroxime 9/505 1.8% 8/503 1.6% 0.813 520


[21] 1.5 g

Perez [22] 360 61 98 Cefazolin 7/180 3.9% 4/180 2.2% 0.540 59


1g

Tzovaras [23] 379 63 94 Amoxicillin 9/189 4.7% 5/190 2.6% 0.4 48


+ clavulanic
acid 1.2 g

Jain [24] 120 41 100 Amoxicillin 1/60 1.7% 1/60 1.7% 0.500 ∞
+ clavulanic
acid 1.2 g
aNumber
of hernias (91 patients)

mesh repair is not higher than the percentage after after mesh groin hernia repair did not favour the
conventional sutured repair [11] (4.0%). Because use of antibiotic prophylaxis: OR 0.59 (95% CI 0.34–
the use of antibiotics is not likely to increase the 1.03) and NNT 80 (49–1,111). In the meta-analysis,
wound infection percentage, the net effect of stud- only one study of below-average size demonstrated
17 ies designed as those that were included will almost a large and significant benefit for the prophylaxis
always be zero or will be in favour of the patients’ group, but this study can be criticised because of
receiving prophylaxis and therefore on the left (an- repeated aspiration of seromas and excessive use of
tibiotic-favouring) side of the forest plot. drains that could cause (secondary) infections; also,
The meta-analysis of six nonmesh studies dem- it is likely that the study was underpowered because
onstrated a nonsignificant effect of antibiotic pro- it was, unfortunately, prematurely stopped because
phylaxis: OR 0.75 (0.53–1.06), NNT 85 (45–359). of the high rate of wound infection.
The meta-analysis of eight studies on the use of However, there can be a debate about the
antibiotic prophylaxis to prevent wound infection method used for meta-analysis in this chapter be-
Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection
131 17

⊡ Table 17.5. Pooled data of eight studies on the use of antibiotic prophylaxis for preventing wound infection after mesh
inguinal hernia repair
Review: The effectiveness of antibiotic prophylaxis in inguinal hernia repair
Comparison: 01 Antibiotic prophylaxis vs placebo
Outcome: 01 Total number of wound infections

Study or Antibiotic Placebo OR (random) Weight OR (random) Year


sub-category n/N n/N 95% Cl % 95% Cl

Morales 4/237 6/287 16.78 0.80 [0.22, 2.88] 2000

Yerdel 1/136 12/133 7.02 0.07 [0.01, 0.58] 2001

Aufenacker 8/503 9/505 27.05 0.89 [0.34, 2.33] 2004

Celdran 0/50 4/49 3.51 0.10 [0.01, 1.91] 2004

Oteiza 1/124 0/123 2.97 3.00 [0.12, 74.36] 2004

Perez 4/180 7/180 17.51 0.56 [0.16, 1.95] 2005

Tzovaras 5/190 9/189 21.27 0.54 [0.18, 1.64] 2007

Jain 1/60 1/60 3.89 1.00 [0.06, 16.37] 2008

Total (95% Cl) 1480 1526 100.00 0.59 [0.34, 1.03]

Total events: 24 (Antibiotic), 48 (Placebo) 0.01 0.1 1 10 100


Favours treatment Favours control
Test for heterogeneity: Chi2 = 7.70, df = 7 (P = 0.36), I2 = 9.1%
Test for overall effect: Z = 1.86 (P = 0.06)

⊡ Table 17.6. Pooled data of six studies (Morales and Tsovaras data not available) on the use of antibiotic prophylaxis for
preventing deep wound infection after mesh groin hernia repair
Review: The effectiveness of antibiotic prophylaxis in inguinal hernia repair
Comparison: 01 Antibiotic prophylaxis vs placebo
Outcome: 02 Deep infections

Study or Antibiotic Placebo OR (random) Weight OR (random) Year


sub-category n/N n/N 95% Cl % 95% Cl

Yerdel 1/136 3/133 38.96 0.32 [0.03, 3.13] 2001

Aufenacker 1/503 2/505 34.98 0.50 [0.05, 5.54] 2004

Celdran 0/50 0/49 Not estimable 2004

Oteiza 0/124 0/123 Not estimable 2004

Perez 1/180 1/180 26.12 1.00 [0.06, 16.11] 2005

Jain 0/60 0/60 Not estimable 2008

Total (95% Cl) 1053 1050 100.00 0.50 [0.12, 2.09]

Total events: 3 (Antibiotic), 6 (Placebo) 0.01 0.1 1 10 100


Favours treatment Favours control
Test for heterogeneity: Chi2 = 0.39, df = 2 (P = 0.82), I2 = 0%
Test for overall effect: Z = 0.94 (P = 0.35)
132 Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection After Groin Hernia Surgery?

cause meta-analysis is a nonperfect technique that If a much higher percentage of wound infec-
is no substitute for a large and well-designed ran- tions exists because of patient or surgical char-
domised controlled study. Nonetheless, the tech- acteristics [28], as demonstrated by two of the
nique is indicated for similar situations in which inguinal hernia studies, the use of antibiotic pro-
the number of patients in the studies is low or phylaxis could be reevaluated. In the trials with
when results are conflicting, as it provides pooled high wound infection percentages, two important
estimates with narrower CIs and greater statistical differences can be seen: The duration of surgery
power. But the interpretation of a meta-analysis, was 1.5 times longer (64 min), and drains were
especially which method to use, is essential. The used more often (22%), both known risk factors
choice of method should be based on the pres- for infection [29, 31].
ence or absence of statistical heterogeneity within This review shows the lack of randomised
the data together with the clinical diversity and studies of laparoscopic groin hernia repairs on the
methodological diversity of the original studies. In subject of wound infection. The only laparoscopic
the presence of statistical heterogeneity, it is better inguinal hernia (transabdominal preperitoneal) re-
not to perform a meta-analysis. In the eight stud- pair study discussed 80 patients without proper
ies used for the current meta-analysis, there is no randomisation (alternately), but it demonstrated
statistical heterogeneity (e.g. p=0.36, I2= 9.1). The no infections. This study virtually excludes the
studies are, unfortunately, clinically and method- presence of a high percentage of wound infections
ologically diverse; for instance, there is large varia- in laparoscopic repair. There is some logic in this
tion among the included studies regarding recur- low infection rate since the minimally invasive ap-
rent hernia, diabetes, bilateral repair, use of local proach consists of small and occluded incisions, al-
anaesthetics, and the surgeon’s level of expertise. though the operating time is an average of 18 min
To correct for this clinical and methodological di- longer compared with an open repair [32]. Consid-
versity, the random method should be used rather ering these aspects, and as long as hard evidence is
than fixed analysis. Especially when the results lacking, it is probably acceptable to conclude that
of the fixed and random analysis conflict, as in in laparoscopic inguinal hernia repair, no antibi-
the current situation, the choice of meta-analysis otic prophylaxis is needed.
method should preferably be conservative, and in It is not expected that important publications
these situations the random method should also be were missed in our thorough search of the litera-
used [27, 28]. ture and our contacts with authorities in the field.
An infection percentage in low-risk patients It is, however, difficult to assess the possibility of
should be below 2% [29] when performing clean publication bias, resulting in studies being left out
inguinal or femoral hernia surgery lasting less than that showed no effect of antibiotic prophylaxis for
1 h. Therefore, the question should be, »Should we the procedures included in our analysis. On the
administer antibiotics to all patients undergoing other hand, if publication bias exists, the effect of
clean surgery to spare a few (sometimes a very antibiotic prophylaxis would be even more mod-
few) superficial wound infections?« [30]. Because est than we found in our meta-analysis, as failure
a relatively simple treatment of wound drainage, to include the grey literature has been reported to
frequently combined with antibiotics, is required overestimate a treatment effect by 15% [33].
17 for superficial infections, and because the rare deep From this meta-analysis it can be concluded
infections result in a low number of mesh removals that in clinical settings with low rates of infection,
(0.09% [10] –1.1% [18]) with remarkably few her- there will be no significant benefit from using
nia recurrences, there remains no routine indica- antibiotic prophylaxis for groin hernia repair in
tion for antibiotic prophylaxis in low-risk patients. low-risk patients. Because of an unknown impact
Discarding the use of antibiotic prophylaxis in her- on bacterial resistance [13], the use of routine
nia repair could reduce costs, the risks of toxic and antibiotic prophylaxis in primary inguinal her-
allergic side effects, and the possible development nia repair should therefore be discouraged. In the
of bacterial resistance [13] or superinfections. Netherlands, the cost benefit for one patient is rel-
Chapter 17 · Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection
133 17
the use of antibiotic prophylaxis: OR 0.59 (95% CI
⊡ Table 17.7. Patient and operation characteristics that
may influence the risk of wound infections [28] 0.34–1.03) and NNT 80 (49–1,111).
From this meta-analysis it can be concluded
Patient Operation that in clinical settings with low rates of infection,
there will be no significant benefit from using an-
Age Duration of surgical scrub tibiotic prophylaxis for groin hernia repair in low-
Nutritional status Skin antisepsis risk patients. However, if patient or surgical char-
Diabetes Preoperative shaving
acteristics prove the existence of a much higher
Smoking Preoperative skin prep
Obesity Duration of operation percentage of wound infections, as demonstrated
Coexistent infection at Antimicrobial prophylaxis by two of the inguinal hernia studies, the use of
a remote body site Operating room ventilation antibiotic prophylaxis could be reevaluated.
Colonisation with Inadequate sterilisation of
microorganisms instruments
Altered immune Foreign material in the surgi-
response cal site
Acknowledgments
Length of preopera- Surgical drains
tive stay Surgical technique The author wants to thank M. J. Koelemay, M.D.,
Ph.D., and M. P. Simons, M.D., Ph.D., for their
help with this study.

atively limited (€13.20) [34]. Nevertheless, because


of the large number of inguinal hernia repairs References
performed in low-risk patients (an estimated 70%
of all hernias) [21], discarding the use of antibiotic 1. Bay-Nielsen M, Kehlet M, Strand L, Malmstrom J, Ander-
prophylaxis will save at least €10 million in Europe sen FH, Wara P, Juul P, Callesen T; Danish Hernia Database
Collaboration (2001). Quality assessment of 26,304 herni-
and the United States. There is, of course, not
orrhaphies in Denmark: a prospective nationwide study.
enough evidence regarding the high-risk group of Lancet 358:1124–1128
patients (⊡ Table 17.7). To answer this question, an- 2. Arroyo A, Garcia P, Perez F, Andreu J, Candela F, Calpena
other large trial would be needed, or, better yet, the R (2001). Randomized clinical trial comparing suture
source data of the separate trials should be analy- and mesh repair of umbilical hernia in adults. Br J Surg
88:1321–1323
sed. Therefore, an attempt is currently being made
3. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk
to contact all authors of randomised controlled EG, Jeekel J (2004). Long-term follow-up of a randomized
trials and ask them to deliver their source data for controlled trial of suture versus mesh repair of incisional
final analysis. hernia. Ann Surg 240:578–585
Currently it can be stated that surgeons and 4. Nilsson E, Haapaniemi S, Gruber G, Sandblom G (1998).
Methods of repair and risk for reoperation in Swedish her-
hospitals must assess their own surgical site in-
nia surgery from 1992 to 1996. Br J Surg 85:1686–1691
fection rates to define if prophylactic antibiotics 5. Nyhus LM, Alani A, O’Dwyer PJ (2004). The problem: How to
must be widely used in all patients. For clinical treat a hernia. In: Schumpelick V, Nyhus LM (eds) Meshes:
settings with low rates of surgical site infections, benefits and risks, 1st edn. Springer, Berlin, pp 3–30
selective use of antibiotics based on patients’ and 6. EU Hernia Trialists Collaboration (2000). Mesh compared
with non-mesh methods of open groin hernia repair: sys-
surgical risk factors is probably the best therapeu-
tematic review of randomized controlled trials. Br J Surg
tic strategy. 87:854–859
7. EU Hernia Trialists Collaboration (2002). Repair of groin
hernia with synthetic mesh, meta-analysis of randomized
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8. Lichtenstein IL, Shulman AG, Amid PK, Montller MM
(1989). The tension-free hernioplasty. Am J Surg 157:188–
The meta-analysis of eight studies on the use of 193
antibiotic prophylaxis for preventing wound infec- 9. Stephenson BM (2003). Complications of open groin her-
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10. Taylor SG, O’Dwyer PJ (1999). Chronic groin sepsis follow- 24. Jain SK, Jayant M, Norbu C (2008). The role of antibiotic
ing tension-free inguinal hernioplasty. Br J Surg 86:562– prophylaxis in mesh repair of primary inguinal hernias
565 using Prolene hernia system: a randomised prospective
11. Sanchez-Manuel FJ, Seco-Gil JL (2004). Antibiotic pro- double-blind control trial. Trop Doct 38(2):80–82
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18(4):CD003769 (1992). CDC definitions of nosocomial surgical site infec-
12. Rutkow IM (2003). Demographic and socioeconomic as- tions, 1992: a modification of CDC definitions of surgical
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13. Waldvogel FA, Vaudaux PE, Pittet D, Lew PD (1991). Pe- sion bias in metaanalysis. Int J Epidemiol 34:79–87
rioperative antibiotic prophylaxis of wound and foreign 27. Alderson P, Green S. Cochrane Collaboration open learn-
body infections: microbial factors affecting efficacy. Rev ing material for reviewers, version 1.1. Available at http://
Infect Dis 13 (suppl 10):S782–789 www.cc-ims.net
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cc-ims.net/RevMan (1999). Guideline for prevention of surgical site infection,
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tic tissue? Zentralbl Chir 123:193–195 gical infection of drains and the risk of wound infection in
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18. Yerdel MA, Akin EB, Dolalan S, Turkcapar AG, Pehlivan M, Surg 90:1479–1492
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trial. Ann Surg 233:26–33 34. Z-index database of Koninklijke Nederlandse Maatschap-
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20. Oteiza F, Ciga MA, Ortiz H (2004). Antibiotic prophylaxis in
inguinal herniaplasty. Cir Esp 75:69–71
21. Aufenacker TJ, van Geldere D, van Mesdag T, Bossers AN, Discussion
Dekker B, Scheijde E, van Nieuwenhuizen R, Hiemstra E,
Maduro JH, Juttmann JW, Hofstede D, van der Linden
CT, Gouma DJ, Simons MP (2004). The role of antibiotic Klinge: Do you think that this problem of mesh
prophylaxis in prevention of wound infection after Lich- infection and late mesh infection is an issue for
tenstein open mesh repair of primary inguinal hernia. A meta-analysis and clinical studies?
multi-center double-blind randomized controlled trial. Aufenacker: It would be quite difficult to do the
Ann Surg 240:955–961
follow-up of such a study. If you want to prove the
17 22. Perez AR, Roxas MF, Hilvano SS (2005). A randomized,
short-term effect of this infection, you need a large
double-blind, placebo-controlled trial to determine effec-
tiveness of antibiotic prophylaxis for tension free mesh population.
herniorrhaphy. J Am Coll Surg 200:393–398 Simons: Do you think it would be good to use an-
23. Tzovaras G, Delikoukos S, Christodoulides G., Spyridakis tibiotics in cases of patients with risk factors, such
M, Mantzos F, Tepetes K, Athanassiou E, Hatzitheofilou C
as smokers?
(2007). The role of antibiotic prophylaxis in elective ten-
sion-free mesh inguinal hernia repair: results of a single Aufenacker: In our study, we do not look at smok-
centre prospective randomised trial. Int J Clin Pract 61 ing-related factors, so I can’t answer this question
(2):236–239 yet.
18

Infection Control in a Hernia Clinic:


24-Year Results of Aseptic and
Antiseptic Measure Implementation
in 4,620 »Clean Cases« Based on
Up-To-Date Microbiological Research
M. Deysine
136 Chapter 18 · Infection Control in a Hernia Clinic

Introduction Initially, the operating room aseptic and anti-


septic measures used were the standard ones for
The wound infection rate for both ventral and so-called clean cases. Wounds were not irrigated,
inguinal herniorrhaphy has remained at virtually and we did not use intravenous antibiotics.
the same unacceptable level for the last 60 years: In 1982, after the occurrence of five almost
between 3% and 4% for inguinal hernias and be- consecutive postinguinal herniorrhaphy wound
tween 8% and 14% for ventral hernias. Thus, ap- infections, we modified our protocol by enhancing
proximately 30,000 inguinal and 3,000 ventral re- strict aseptic measures created by others. In addi-
pairs become infected yearly in the United States tion, patients received a preoperative intravenous
alone, and European figures may be similar [2–3]. injection of 1 g cefazolin. We also irrigated the
During the last 20 years the introduction of operative sites with a solution of 80 mg gentamicin
mesh repairs has considerably changed the prog- sulfate diluted into 250 ml normal saline solution,
nosis of these infections, whose successful treat- starting immediately after opening the external
ment requires a sequence of often crippling or oblique aponeurosis and continuing intermittently
even life-threatening reoperations [4]. until the skin was closed. (See ⊡ Table 18.1).
This paper reports our 25-year experience Postoperatively, patients were seen by the au-
with »clean« postherniorrhaphy wound infection thor at 7 days, at 1 month, and at yearly intervals
prevention. During this period, vast advances have thereafter. Wound infection was defined as the ap-
been made by groups studying the biological rela- pearance of pus or any other exudate anywhere in
tionships among bacteria, prostheses, and hosts a wound, any time after surgery.
[5–8]. The emerging information solidly supports
the application of seasoned surgical principles that
function by diminishing the number of microbes Results
entering the wound, decreasing their available
food supply, and killing them with antibiotics Since 1981 we have performed 4,300 »clean« inguinal
[9, 10]. However, recent discoveries dealing with herniorrhaphies under a published protocol. We used
bacterial »quorum sensing« and its inhibitors may the Shouldice technique in 2,500 and mesh or plug
favorably apply to the prevention and treatment of repair for the rest. Five postinguinal herniorrhaphy
infections related to surgically implanted foreign wound infections occurred (11%), the last one in
bodies. 1982. All of them occurred in patients operated
Our results suggest that with the application of with the Shouldice technique. Four of the wounds
up-to-date knowledge dealing with the interaction grew coagulase-positive Staphylococcus aureus. All
between biomaterials and bacteria, posthernior- infections were treated by opening the skin from end
rhaphy wound infections may become a prevent- to end and the wound down to the infected layer,
able complication. with extensive debridement of all necrotic tissue and
suture material. Wounds were irrigated at daily inter-
vals with normal saline solution, and the patients re-
Methods and Materials ceived short-term courses of specific antibiotics. All
wounds healed by secondary intention. Two patients
In 1981 we created a hernia clinic where patients developed recurrences and were reoperated 6 weeks
were treated under a protocol that has been re- after the wounds were completely healed.
ported elsewhere [11–12]. At the onset, we ad- Three hundred and thirty »clean« ventral
18 opted the Shouldice technique for inguinal repairs, herniorrhaphies were performed utilizing a variety
which was progressively replaced by mesh repairs of mesh techniques and materials. Three patients
using expanded polytetrafluoroethylene (ePTFE), in whom the defects were corrected with ePTFE
polypropylene, and Dacron polyester meshes. Ven- meshes developed wound infections (0.9%) re-
tral herniorrhaphy underwent a similar evolution- quiring mesh removal. All of these wounds grew
ary pattern [10]. coagulase-positive Staphylococcus aureus. These
Chapter 18 · Infection Control in a Hernia Clinic
137 18
Since the inception of these aseptic and anti-
⊡ Table 18.1. Aseptic and antiseptic measures ad-
opted in 1982 to decrease wound contamination by septic measures in 1982, we have not experienced
operating room environmental bacteria wound infections in »clean« inguinal or ventral
hernia repairs
In the preoperating room:
1. Patient’s abdomen is shaved or clipped just before
surgery
2. Patient receives 1 g intravenous cefazolin Discussion
In the operating room:
1. Team emphasis on measures to prevent prosthe- After the landmark work of Semmelweis, Pasteur,
sis contamination and Lister, the wound infection rate for »clean«
2. Team awareness of operating room preparations:
general surgical cases fell from virtually 100% to
face masking, scrubbing, gowning, gloving, in-
strument package handling about 10%. This rate was further reduced around
3. Double gloving, with changes of the external 1950 to approximately 4% by improvements in op-
glove every 45 min erating room aseptic and antiseptic measures plus
4. Avoidance of nonessential personnel traffic
the introduction of perioperative and postoperative
through the operating room
5. Team awareness of all moves that may produce antibiotics. However, no further improvement in
contamination the »clean« wound infection rate has been recorded
Surgical measures for the last 40 years [4]. This situation may be the
1. Ensure that skin preparation vastly exceeds the result of less than optimal implementation of time-
wound area; include the scrotum for inguinal tested aseptic measures associated with a false sense
herniorrhaphy
of security emerging from antibiotic availability.
2. Drape the patient carefully
3. Emphasize scissors or scalpel dissection Furthermore, the actual wound status termi-
4. Use electrocautery sparsely nology may be deceiving because so-called clean
5. Keep dissection circumscribed to relevant areas wounds are far from sterile. Abundant evidence
6. As soon as the external oblique aponeurosis is
in the literature demonstrates that such wounds
opened (for inguinal or ventral hernias), start
wound irrigations with a solution of 80 mg gen- contain bacteria at the time of closure, coming
tamicin sulfate dissolved in 250 ml normal saline from the air, bodies, or surgical instruments. Hub-
7. Irrigate as often as possible ble et al. demonstrated that operating room air
8. Approximate tissues to themselves and to the
might contain up to 1,000 colony-forming units
prosthesis, using the minimum tension necessary
to permit appropriate contact and avoid tissue per mm3 [13]. Taylor and Bannister showed that a
strangulation surgeon leaning over a wound increases the bacte-
9. Place the prosthesis into the gentamicin solution rial wound count by 27-fold [14], and Dillon et al.
as soon as it leaves the package; consider the op-
erating room air to be contaminated with bacteria
showed that 23% of »clean wounds« grew bacteria
10. Avoid excessive retraction, clamping, or tissue and that postoperative infections of those wounds
crushing with any kind of instrument were 10 times more common [15]. This means that
11. Avoid hand retracting or dissection during »clean« surgery, both the wound and the
12. Excise all devitalized tissue
13. Before closing the external oblique aponeurosis,
prosthesis will become contaminated by bacteria
debride the wound with a dry gauze to remove to various degrees.
clots, separated fat tissue, etc. However, our knowledge of wound infection
14. Avoid drain placement; if needed, use it for only has rapidly increased because, during the last 30
24 h, and keep the patient on intravenous antibi-
otics all of that time years, biochemical engineers, microbiologists, and
general and orthopedic surgeons have clarified
the interactions among bacteria, host tissues, and
prosthetic polymers [5–8, 16–19].
patients were reoperated 6–12 months later using As demonstrated by several investigators
various techniques. No infections were observed [14–16], bacteria will enter a wound from a variety
in »clean cases« receiving either polypropylene or of operating theater sources. These microorgan-
Dacron polyester meshes [10]. isms depend on food substrate for their survival,
138 Chapter 18 · Infection Control in a Hernia Clinic

and mortified tissue and plasma-coated prosthetic the protocol. The killing effect of the gentamicin
polymers meet this nutritional demand [20]. Sub- is concentration dependent and is followed by a
sequently, by producing high-quality adhesives that bacteriostatic effect. Although it is most effective
allow their survival and further colonization, bac- against gram-negative bacteria, gentamicin also
teria rapidly hold fast to those nourishing surfaces. has killing activity against staphylococci, both S.
The forthcoming colonization is then followed by aureus and S. epidermidis. The empirical choice
a host–immune response leading to suppuration of a highly concentrated gentamicin solution may
[5, 6, 8]. explain our results because, at the level used, gen-
In 1970, Nealson et al. [21] reported on the tamicin would be bactericidal and not bacterio-
cellular control of the synthesis and activity of a static [22]. Most important, because gentamicin
bacterial luminescent system regulated by a sys- shows antimicrobial synergy when used in combi-
tem of intercellular communications. This led to nation with beta-lactams, the cefazolin may have
a series of discoveries demonstrating that gram- contributed to successful bacterial killing [23].
positive and gram-negative bacteria communicate Gentamicin is not harmless and can produce
with each other by releasing chemical molecules auditory and renal damage at high serum concen-
called autoinducers, which regulate gene expres- trations. Concerned about such side effects, we
sion in response to changes in population density. measured gentamicin serum levels in 10 consecu-
This process allows bacteria to build community tive postinguinal herniorrhaphy patients 1 h post-
structures and regulate biofilm and toxin produc- operatively and found undetectable levels. Ven-
tion. In essence, the quorum sensum is responsible tral herniorrhaphies, in contrast, present a larger
for bacterial contamination of tissues and biomate- surface; for those cases, we recommend avoiding
rials plus further toxin production. peritoneal contact with the gentamicin solution
These landmark discoveries led to the identi- because it will be rapidly absorbed by the sero-
fication of an autoinducer RAP (33–kDa autoin- sal surface. Compresses soaked in the gentamicin
ducer RNAIII-activating protein), which induces solution can be used to protect the wound edges
the phosphorylation of the target of RAP (TRAP). while or until the peritoneum is closed, at which
TRAP is a 21–kDa protein that regulates the ex- time wound irrigations can continue. We have not
pression of toxins. Most importantly, in the absence encountered any cases of otic or renal toxicity.
of TRAP expression of phosphorylation, bacteria Salvati and others have monitored serum gen-
do not produce toxins, and they fail to cause dis- tamicin levels after the treatment of infected or-
ease. Recently, the quorum-sensing inhibitor RIP thopedic wounds with pellets containing the an-
[RNAIII-inhibiting peptide (YSPWTNF–NH2)] tibiotic, showing minimal or no detectable levels
showed the capacity to inhibit TRAP phosphory- [24–27]. Recently, gentamicin irrigations have
lation, thereby preventing infection of implanted been successfully used by neurosurgeons to pre-
devices in several animal models. Finally, RIP has vent postcraniotomy infections [28]. Addition-
been found to have significant activity in treating ally, Junge et al. successfully bonded gentamicin
methicillin-resistant staphylococcal infections in to polyvinylidene fluoride mesh material, dem-
a rat model, suggesting its use as a therapeutic onstrating that the antibiotic retained its antimi-
constituent. From these data, it is evident that a crobial activity after implantation. These findings
new era of infection control and treatment may be open the possibility of creating a mesh that could
emerging. resist microbial colonization [29].
In 1982 we decided to test the effect of ir- The use of preoperative intravenous antibiot-
18 rigating inguinal herniorrhaphy wounds with a ics is a much debated issue [30–39]. In spite of the
concentrated solution of gentamicin sulfate. In ad- controversy, we choose to use them because we
dition, the prosthesis was placed in the gentamicin believe it could balance the infection struggle in
solution directly from the package and from there our patients’ favor.
into the wound. Further to this, a preoperative Inguinal herniorrhaphy is one of the few sur-
intravenous injection of 1 g cefazolin was added to gical procedures in which the surgeon deals with
Chapter 18 · Infection Control in a Hernia Clinic
139 18
initially sterile tissues. Therefore, the amount of New discoveries by microbiologists may fur-
bacteria present at closure should become a con- ther enhance the field of infection prevention and
trollable factor. Consequently, in addition to the treatment.
antibiotic regimen, we strictly emphasized aseptic
measures developed by others because we believed
in their usefulness. Patients were shaved by the References
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these results can henceforth be substantiated only 17. Lidwell OM, Lowbury EJ, Whyte W, et al. (1982) Effect of
by further studies. ultraclean air in operating rooms on deep sepsis in the
140 Chapter 18 · Infection Control in a Hernia Clinic

joint after total hip or knee replacement: a randomised 34. Troy MG, Quan-Sheng Dong, Dobrin PB, et al. (1996) Do
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131 flammatory response to open tension-free inguinal her-
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18 326:281–286 gery and laser. Am J Surg 119:222–224
32. Wong-Beringer A, Corelli RL, Schrock TR, et al. (1995) 50. Olivar AC, Forouhar FA, Gillies CG, et al. (1999) Trans-
Influence of timing of antibiotic administration on tissue mission electron microscopy: evaluation of damage in
concentrations during surgery. Am J Surg 169:379–381 human oviducts caused by different surgical instruments.
33. Hill C, Mazas F, Flamant R, et al. (1981) Prophylactic ce- Ann Clin Lab Sci 29:281–285
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1:795–797 we doing all we can? [letter] Hernia 8:90–91 Discussion
Chapter 18 · Infection Control in a Hernia Clinic
141 18
Discussion

Smeds: What are the reasons for your low infec-


tion rate?
Deysine: It’s a combination of things I did. First of
all, I try to get my operating room sterile, and I use
prophylactic antibiotics because it makes sense to
me. It’s only one injection; it works in orthopedic
patients.
Kehlet: We hear about these large personal series
with zero problems in anything. And then we have
these series from randomized studies with infec-
tion rates up to 9%. How can we proceed, because
there is a discrepancy between these difference
experiences?
Deysine: I believe in technique, and I think that
doing this kind of operation properly without ad-
ditional damage of tissue leads to these good re-
sults.
19

Components Separation Technique:


Pros and Cons
B. M. van der Kolk, T. S. de Vries Reilingh, O. Buyne,
R. P. Bleichrodt
144 Chapter 19 · Components Separation Technique: Pros and Cons

Introduction of the muscles to restore the anatomy of the ventral


abdominal wall. The method and its modifica-
Prosthetic repair is still the most frequently applied tions have been described in detail by Bleichrodt
method to repair ventral hernias. However, pros- and coworkers [5–8]. This chapter describes the
thetic materials have several drawbacks. First, the relevant anatomy of the ventral abdominal wall
mechanical properties of the abdominal wall may and the surgical technique, summarizes the results,
be altered, providing less dynamic support and a and discusses the sequelae and possible solutions
less favorable cosmetic result owing to bulging of to prevent them.
the prosthesis. Second, the prosthetic material may
cause damage to the intraabdominal viscera if the
peritoneum or greater omentum cannot be inter- Anatomy
posed between the prosthesis and the organs [1].
Third, biomaterials increase the risk of infection, The anatomy in relation to the components sepa-
particularly when they are used for reconstruction ration technique (CST) has been described by Ble-
in a contaminated environment, such as the ab- ichrodt et al. [5] and is summarized here. The skin
dominal wall in the presence of an enterocutane- and subcutaneous tissue cover the muscles of the
ous fistula [2, 3]. ventral abdominal wall. The muscles of the ventro-
In 1990, Ramirez et al. [4] described a tech- lateral abdominal wall are the external oblique, in-
nique for reconstructing abdominal wall defects ternal oblique, and transversus abdominis, which
without using prosthetic material. It is based on insert into the anterior and posterior sheaths of the
enlargement of the abdominal wall surface by rectus abdominis muscle (⊡ Fig. 19.1). The arterial
translation of the muscle layers to bridge fascial blood supply of the skin comes mainly from the
defects of up to 28 cm at the waistline without intercostal arteries and the perforating branches
compromising the innervation and blood supply of the epigastric artery (⊡ Fig. 19.2). The innerva-

⊡ Fig. 19.1. Anatomy of the abdominal wall. The skin and sub- part. The anterior part forms the anterior layer of the rectus
cutaneous tissue cover the muscles of the ventral abdominal sheath, together with the external oblique muscle. The pos-
wall. The muscles of the ventrolateral abdominal wall are the terior part fuses with the transversus abdominis, forming the

19 external oblique, internal oblique, and transversus abdominis,


which insert into the anterior and posterior sheaths of the
posterior rectus sheath, superior to the linea semilunaris. The
neurovascular bundle runs between the internal oblique and
rectus abdominis muscle. The aponeurosis of the external transversus abdominis muscle and penetrates the posterior
oblique muscle forms the anterior rectus sheath. The internal rectus sheath at the posterolateral side. (Reproduced with
oblique aponeurosis divides into an anterior and posterior permission from Bleichrodt et al. [5])
Chapter 19 · Components Separation Technique: Pros and Cons
145 19

⊡ Fig. 19.2. Blood supply of the skin and muscles of the intercostal arteries, but also by branches of the superficial epi-
ventral abdominal wall. The blood supply of the ventral ab- gastric artery and the superficial circumflex iliac and external
dominal wall stems mainly from the epigastric and intercostal pudendal arteries (c). The blood supply of the muscular layers
arteries. The skin of the ventral abdominal wall is supplied by of the abdominal wall stems from the (e) superior and (f) infe-
the (a) periumbilical musculocutaneous perforators of the rior epigastric arteries, together with the intercostal arteries
(b) superior and (c) inferior epigastric arteries and the (d) (g). (Reproduced with permission from Bleichrodt et al. [5])

tion of the anterolateral ventral abdominal wall is abdomen, 7–10 cm at the waistline, and 1–3 cm in
shown in ⊡ Fig. 19.3. The muscles are innervated the lower abdomen. A further gain of 2–4 cm can
by the 7th–12th intercostal nerves and the iliohy- be achieved by separating the posterior sheath of
pogastric and ilioinguinal nerves. the rectus abdominis muscle. The abdominal wall
is closed in the midline with a running suture of
a nonabsorbable or slowly absorbable suture ma-
Components Separation Technique terial. Suction drains are placed subcutaneously,
(⊡ Fig. 19.3a–e) and the subcutis and skin are closed. Defects of
up to 28 cm in the waistline can be bridged in this
The skin and subcutaneous fat are dissected free way. After closure of the linea alba, the external
from the anterior rectus sheath and the aponeu- oblique muscle and the posterior rectus sheath are
rosis of the external oblique muscle. By doing this, retracted laterally.
the perforating branches of the epigastric artery
are transected. The aponeurosis of the external
oblique muscle is incised 1–2 cm lateral to the Overall Results
lateral border of the rectus abdominis muscle. The
myoaponeurosis of the external oblique muscle The results of CST up to 2007 were reviewed by
is transected longitudinally over its full length. de Vries Reilingh et al. [8]. Operative technique,
Transection includes the muscular part of the ex- complications, and recurrence rates were the main
ternal oblique muscle on the thoracic wall. With points of interest. As of 2007, 15 series had been
this extension, the rectus abdominis muscle can be published on the results of abdominal wall repair
maximally shifted medially in the upper abdomen. using CST: one randomized controlled trial and 14
The external oblique muscle is separated from the retrospective series. The technique varied among
internal oblique muscle in the avascular plane be- the studies. In all studies, transection of the exter-
tween both muscles. With this technique, the rec- nal oblique muscle was performed; in six, a release
tus muscle can be advanced 3–5 cm in the upper of the posterior rectus sheath was carried out as
146 Chapter 19 · Components Separation Technique: Pros and Cons

⊡ Fig. 19.3. The neurovascular bundle in relation to the ab- rovascular bundles penetrate the internal oblique contribu-
dominal wall musculature. The muscles of the anterolateral tion to the posterior rectus sheath at the posterolateral side
ventral abdominal wall are innervated by the 7th–12th inter- to supply the rectus muscle (g) and the overlying skin. The
costal nerves and the iliohypogastric and ilioinguinal nerves. neurovascular bundles enter the rectus sheath close to the
The nerves (a) run forward together with the accompanying axis of the epigastric arteries, about 10–25 mm medially from
arteries and veins between the internal oblique (b) and the the lateral border of the rectus sheath (e). (Reproduced with
transversus abdominis (c) muscle. Branches are supplied to permission from Bleichrodt et al. [5])
the muscle and the overlying skin (d). The segmental neu-

well. Two studies described an extension of the infection was the most common complication,
original technique [6, 7]: a release of the anterior found in 18.9% (95% CI 14.9–23.2); seroma in
rectus sheath in one series and transection of the 2.4% (95% CI 1.0–4.2); hematoma in 2.4% (95%
transverse abdominal muscle in selected patients. CI 1.0–4.2); and skin necrosis in 1.5% (95% CI
In three series, incidental prosthetic onlay mesh 0.5–3.1). A follow-up period of at least 1 year after
support was used. operation was reported in five series that included
The overall quality of the studies was moderate 134 patients; 27 patients (18.2%; 95% CI 5.4–36.2)
according to the MINORS criteria. One prospec- had a recurrent hernia.
tive randomized trial comparing CST and pros-
thetic repair was performed, having a MINORS
index of 12. Fourteen retrospective series includ- Sequelae and Prevention
ing 460 patients were published, with a mean MI-
NORS index of 7 (range 3–8). Eleven retrospective Hematoma, Seroma, and Wound
studies with a MINORS index ≥5 were pooled with Infection
the 19 patients in the randomized controlled trial,
giving a total of 479 patients [9–20]. When performing CST, a very large subcutaneous
Overall mortality was 1.2% (three out of 248 wound surface, approaching 1,000 cm2, is created,
19 patients in seven series). Wound complications extending from the thorax to the inguinal region
were observed in 12 series that included 354 pa- and in the lateral direction to the midaxillary line
tients. Wound complications were found in 23.8% on both sides. Hematoma (2.4%), seroma (2.4%),
[95% confidence interval (CI) 18.3–29.8]. Wound infection (18.9%), and skin necrosis are the most
Chapter 19 · Components Separation Technique: Pros and Cons
147 19
frequent complications and account for 23.8% of skin necrosis occurred in all patients who were
postoperative complications. Hematomas can be on chronic hemodialysis.
prevented by meticulous hemostasis. Seroma for-
mation is much more difficult to prevent. The in-
flammatory response, which is part of the wound Bulging and Abdominal
healing process, creates an exudate between the Wall Rupture
fascia and the subcutaneous fat layer. Many tech-
niques such as vacuum drains, subcutaneous su- Bulging of the abdominal wall at the side of the re-
tures, fibrin glue, and compression bandages are laxing incisions in the external oblique myoaponeu-
insufficient. Most seromas are asymptomatic and rosis may be a cosmetic problem in patients with a
will disappear within 3–6 months. Some seromas thin subcutaneous fat layer. Because the cosmesis
become very large and endanger the wound heal- of the abdominal wall improves considerably after
ing process in the early phase. If not drained CST and because most patients have a prominent
properly, these seromas will drain spontaneously subcutaneous fat layer, the vast majority of patients
through the skin incision, with the risk of second- do not complain about the distinct swelling on the
ary infection. Chronic seromas can be successfully lateral side of the rectus abdominis muscle.
punctured, and surgery is seldom required. Rupture of the abdominal wall at the side of
Many CST procedures are performed under the relaxing incision is, however, a very serious
contaminated conditions, which may explain the complication of the technique, causing damage to
relatively high wound infection rate. CST is often the neurovascular bundle, including the intercostal
performed in the presence of wounds, enterosto- nerves, which results in paralysis of at least the
mies, and even bowel fistulas. Providing adequate rectus abdominis muscle. Since 2000 we have en-
antibiotic prophylaxis, diminishing the dissec- countered three patients (<1%) with an abdominal
tion subcutaneously, and sparing the perforating wall rupture at the site of incision in the external
epigastric arteries may all contribute to a better oblique muscle. In one of those patients, the rup-
result. ture occurred during operation and was repaired
with mesh immediately. In the second patient, the
rupture occurred the day after surgery and was
Skin Necrosis repaired with a mesh as well. In the third patient,
bilateral ruptures occurred 1 h and 1 week after
The blood supply of the ventral abdominal wall the initial operation, respectively (⊡ Fig. 19.4). The
stems mainly from the epigastric and intercostal hernia was repaired by primary closure and a sub-
arteries. Transection of the epigastric perforat- lay mesh. In two of the three patients, no hernia-
ing arteries endangers the blood supply of the tion had occurred after 1 and 6 years, respectively.
skin of the ventral abdominal wall. Especially in In the patient with an abdominal wall rupture
patients in whom the intercostal arteries have on both sides, the reconstruction on the left side,
been transected–such as in patients with entero- which was performed 6 days after the index opera-
tomies or laparotomies via transverse incisions– tion, was complicated by infection and herniation.
ischemia or even skin necrosis may occur. Skin Definitive repair was done 1 year later. The cause
necrosis has been observed in 1.5% of patients of rupture is unknown.
in the literature. Necrosis is mainly located in It is essential to properly identify the plane
the infraumbilical region in the midline. This between the internal and external oblique muscles.
complication can be prevented by sparing the Accidental transection of the internal oblique mus-
periumbilical epigastric perforators. In our series cle may result in an abdominal wall rupture because
of patients, 5% suffered skin necrosis when the the transversus abdominis muscle is too weak to
classical technique was performed. Skin necrosis resist the intraabdominal pressure. Some surgeons
did not occur in any of the patients in whom the advocate an onlay mesh support to prevent recur-
perforating arteries were spared. In our series, rent hernias or abdominal wall rupture [22].
148 Chapter 19 · Components Separation Technique: Pros and Cons

⊡ Fig. 19.4. Components separation technique. The patient is c The external oblique muscle is separated from the internal
placed in a supine position. The skin is opened via a midline oblique muscle in the avascular plane between both muscles,
incision. If a skin defect exists or if the intestine is covered with superiorly to the midaxillary line. Mobilization is essential
a split-thickness skin graft, the abdominal cavity is entered via because the fibrous interconnections between both muscles
an incision just lateral to the defect. The intestine and other prevent optimal medial shift of the rectus abdominis muscle.
viscera are dissected free from the ventral abdominal wall. By d A further gain of 2–4 cm can be achieved by separating the
doing this, the lateral border of the rectus abdominal muscle posterior sheath of the rectus abdominis muscle. The poste-
can be identified properly from the inside of the abdomen. rior sheath is incised posteriorly, near the midline over its full
a The skin and subcutaneous fat are dissected free from the length. The rectus abdominis muscle can easily be separated
anterior rectus sheath and the aponeurosis of the external from the posterior rectus sheath. e Attention must be paid to
oblique muscle to about 5 cm lateral to the lateral border of not damage the neurovascular bundle laterally. Note the en-
the rectus sheath. Mobilization includes transection of the epi- trance of the neurovascular bundle that penetrates the fascia
gastric perforators endangering the blood supply of the skin. of the internal oblique muscle at a variable distance from the
b The aponeurosis of the external oblique muscle is incised lateral border of the rectus abdominis muscle, near the axis
1–2 cm lateral to the lateral border of the rectus abdominis of the epigastric artery. Damage to the neurovascular bundle
muscle. The myoaponeurosis of the external oblique muscle results in denervation of the rectus abdominis muscle. The
is transected longitudinally over its full length. Transection abdominal wall is closed in the midline with a running suture
includes the muscular part of the external oblique muscle of a nonabsorbable or slowly absorbable suture material (af-
on the thoracic wall that extends at least 7–10 cm cranially. ter Bleichrodt et al. [5])

Nerve Damage between the internal oblique and the transversus


abdominis
The muscles of the anterolateral ventral abdomi- muscle, and branches are given to each mus-
19 nal wall are innervated by the 7th–12th intercos- cle and the overlying skin. After CST, all patients
tal nerves and the iliohypogastric and ilioinguinal have hyposensibility of the ventral abdominal
nerves (⊡ Fig. 19.3). The nerves run forward to- wall skin as a result of transection of the sensory
gether with the accompanying arteries and veins nerves. Denervation of the muscles of the ventral
Chapter 19 · Components Separation Technique: Pros and Cons
149 19
abdominal wall occurs less frequently. Damage
to the nerves that innervate the rectus abdominis
muscle may occur after accidental transection.
This may occur when dissection is performed
in the wrong plane between the internal oblique
muscle and the transverse abdominis muscle, but
also at the entrance of the nerves into the rectus
sheath at the posterolateral side of the rectus
sheath.
After CST, some patients have radiating pain
in the ventral abdominal wall for 6–12 months
postoperatively. The cause of this pain is unknown.
a Stretching of the nerves may be one explanation.

Reherniation

Reherniation after CST is rather frequent. After a


follow-up of at least 1 year, 18.2% had a recurrent
hernia. This percentage is probably actually higher
and approaches the results of suture repair. Most
recurrences are located in the upper abdomen
and are small. Modifying the CST technique may
reduce the incidence of reherniation. Tension-free
repair can be achieved in most patients when
b complete transection of the external oblique myo-
aponeurosis is performed, including mobilizing
the rectus abdominis muscle from the thoracic
wall. Recurrences can be repaired laparoscopically
in most cases.
Recurrence rates in hernia surgery are lower
after mesh repair. This may be the case in CST as
well [21]. Placement of a mesh is simple when the
posterior sheath of the rectus abdominis muscle
can be closed primarily; then the mesh can be
c positioned between the posterior rectus sheath
and the rectus abdominis muscle (⊡ Fig. 19.6a).
When the posterior sheath cannot be closed, the
gap in the posterior rectus sheath is bridged with
a mesh, preferably with an antiadhesive layer
⊡ Fig. 19.5. Rupture of the abdominal wall at the site of the re-
laxing incision in the myoaponeurosis of the external oblique
against adhesions, such as Proceed mesh or Se-
muscle. a Swelling of the abdominal wall that occurred within pramesh (⊡ Fig. 19.6b). The anterior sheath and
1 h of repair using the components separation technique. b At rectus abdominis muscles are then closed pri-
operation, a complete rupture of the abdominal wall muscu- marily and cover the mesh. In 2006, a random-
lature was found at the lateral border of the rectus abdominis
ized controlled trial was initiated to determine
muscle. c Note that the neurovascular bundle is damaged as
well, resulting in (partial) denervation of the abdominal wall
whether a preperitoneal retromuscular mesh in
musculature (adapted from de Vries Reilingh and Bleichrodt combination with CST lowers recurrence rates.
[21] with permission) Kingsnorth et al. [22] combine CST with onlay
150 Chapter 19 · Components Separation Technique: Pros and Cons

a reherniation rate is still high but may be decreased


by combining CST and mesh repair.

References

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b
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Chapter 19 · Components Separation Technique: Pros and Cons
151 19
15. Shestak KC, Edington HJ, Johnson RR. The separation Conclusion of Session II, by J. Kukleta
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tion of massive midline abdominal wall defects: anatomy,
We had a quite extensive session, which can be di-
surgical technique, applications, and limitations revisited.
Plast Reconstr Surg 2000;105: 731–738
vided into three parts: who gets the infection, how
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the difficult abdominal wall. Am J Surg 2004; 188:633–
fections and late-onset mesh infections.
637
18. DiBello JN Jr, Moore JH Jr. Sliding myofascial flap of the We have heard interesting stuff about wound
rectus abdominis muscles for the closure of recurrent oxygen and its impact on wound healing. We have
ventral hernias. Plast Reconstr Surg 1996; 98:464–469 heard about biofilms and learned that it’s more
19. van Geffen HJ, Simmermacher RK, van Vroonhoven TJ, difficult to fight against existing biofilms than to
van derWerken C. Surgical treatment of large contam-
prevent them. But it still seems to be a complex
inated abdominal wall defects. J Am Coll Surg 2005;
201:206–212 part. The impregnation of mesh materials seems
20. Girotto JA, Chiaramonte M, Menon NG, et al. Recalcitrant to be a good idea, but we have to learn more about
abdominal wall hernias: long-term superiority of autolo- that, probably with different materials.
gous tissue repair. Plast Reconstr Surg 2003; 112:106–114 I want to close with the following remarks.
21. de Vries Reilingh TS, Bleichrodt RP. Reply. World J Surg
Decreasing the infection rates by only 3% means
2007; 31:2267–2268
22. Kingsnorth AN, Shahid MK, Valliattu AJ, et al. Open onlay
thousands and thousands of people, so I would not
mesh repair for major abdominal wall hernias with selec- talk about the price of €15 for antibiotics. This is
tive use of components separation and fibrin sealant. our position in Switzerland. For any kind of im-
World J Surg 2008; 32(1):26–30 plants, we use antibiotic prophylaxis.

Discussion

Franz: Can you tell us which mesh you are using in


this randomized study?
Bleichrodt: We are using the Vypro II mesh be-
cause the study was running for a few years and
that was the best mesh at that moment. So we had
to go on with the same mesh; otherwise, we would
have a problem comparing results.
Deysine: Do you use antibiotic irrigation?
Bleichrodt: We use antibiotic prophylaxis in every
patient, and if the operation is longer than 3 hours,
we give it again. Mostly we irrigate the wound with
normal saline to remove, for example, blood clots
and so on, but we don’t add antibacterials. We
don’t have proof that it helps.
III

III Risk for Pain

20 Self-Assessment of Discomfort and Pain after Inguinal


Hernia Repair: A Reflection of Both Individual Pain Propensity
and Surgical Strategy – 155

21 Chronic Pain After Inguinal Hernia Repair – 163

22 What Do We Know About the Pathophysiology and Pathology


of Neuropathic Pain? – 169

23 Surgical Trauma of Nerves–Causes of Neuropathic Pain,


Classification, and Options in Surgical Therapy – 177

24 Risks for Pain–Neuropathic Pain: How Should We Handle


the Nerves? – 185

25 What To Consider as Clinicians About Chronic Postoperative


Pain and Inguinal Herniorrhaphy – 191

26 Risk Factors for Chronic Pain After Groin Hernia


Surgery – 199

27 Ischemic Inflammatory Response Syndrome as an Alternative


Explanation for Postherniorrhaphy Pain – 207

28 Postoperative CRPS in Inguinal Hernia Patients – 213

29 Chronic Pain After Open Mesh Repair of Incisional


Hernia – 221

30 Clinical Results After Open Mesh Repair – 227


31 Acute and Chronic Pain After Laparoscopic Incisional Hernia
Repair – 233

32 Effect of Nerve Identification on the Rate of Postoperative


Chronic Pain Following Inguinal Hernia Surgery – 239

33 Discomfort 5 Years After Laparoscopic and Shouldice Inguinal


Hernia Repair: A Report from the SMIL Study Group – 245

34 Recurrence or Complication: The Lesser of Two Evils?


A Review of Patient-Reported Outcomes from the
VA Hernia Trial – 251

35 Chronic Pain After Inguinal Hernia Repair: The Choice


of Prosthesis Outweighs That of Technique – 257

36 The Effect of Polypropylene Mesh on the Ilioinguinal


Nerve in Open Mesh Repair of Groin Hernia – 265

37 Lightweight Macroporous Mesh vs. Standard Polypropylene


Mesh in Lichtenstein Hernioplasty – 275

38 Does the Choice of Prosthetic Mesh Type Make a Difference


in Postherniorrhaphy Groin Pain? – 279

39 New Understanding of the Causes and Surgical Treatment


of Postherniorrhaphy Inguinodynia and Orchialgia – 287

40 Surgery for Chronic Inguinal Pain: Neurectomy,


Mesh Explantation, or Both? – 293

41 Results of Tailored Therapy for Patients with Chronic


Inguinal Pain – 299
20

Self-Assessment of Discomfort
and Pain after Inguinal Hernia Repair:
A Reflection of Both Individual Pain
Propensity and Surgical Strategy

S. Smeds, L. Löfström, O. Eriksson, A. Kald


156 Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair

Introduction Self-Assessment Instrument:


Sergel Recovery Scale
Discomfort from normal tissue healing after in-
guinal hernia surgery will have largely subsided Self-assessment of preoperative groin problems was
at 3 months. Continued discomfort is referred requested at patients’ first admission to the surgical
to as postherniorrhaphy pain syndromes, which clinic 1–4 weeks before surgery, and SA of postop-
have diverse origins with peripheral neuropathic erative discomfort related to the inguinal hernia
and nonneuropathic sources [1, 2]. In addition to repair was requested 3 months after the operation.
the peripheral surgical trauma, pain perception The preoperative SA questionnaire was given be-
is based on central nervous modulation of pain fore surgery in conjunction with the preoperative
transmission. This may be influenced by age [3,
4] and other biological pain modulators [5, 6].
Expression of pain and discomfort may further be ⊡ Table 20.1. The lower part of column A represents
influenced by socioeconomic factors [7]. Finally, the self-assessment (SA) levels (1–10) in the SA scale.
The »preop« and »postop« columns give the number of
verbal eloquence and the ability to interpret as-
patients in each SA level before and after the operation.
sessment scales may influence final answers on Column B shows the number of patients whose preop-
self-assessment (SA) instruments. erative to postoperative SAs changed by the number
Thus, in addition to the variety of meth- of steps indicated in column A. The maximum number
ods for inguinal herniorrhaphy, each inflicting of steps in the scale that can be registered is 9, i.e. from
level 1 to level 10. This table is automatically updated
a varying degree of peripheral tissue and nerve
when the quality follow-up database program is opened
trauma, the variability of a number of biological
and social factors possibly adds to variability in A Preop Postop B
SA records. It was therefore deemed important -9 0
to closely analyse the SA pattern 3 months after -8 0
hernia repair. The clinic’s register gives further
-7 0
information on the preoperative self-assessed
level of groin discomfort. This gives us an oppor- -6 0
tunity to study the degree of improvement (and -5 1
impairment) following different types of repair at -4 0
a point when a postoperative pain syndrome, by
-3 1
definition, starts.
-2 2
-1 5
Materials and Methods 0 29
1 36 0 49
The Sergel Clinic is responsible for inguinal hernia
2 55 2 65
surgery of all inhabitants in the central part of
the county of Östergötland, Sweden, with a catch 3 112 1 63
area of 228,000 inhabitants. The patient popula- 4 82 2 68
tion covers all primary and recurrent groin hernias 5 69 4 75
among elective patients older than 18 years of both
6 72 9 81
genders and of American Society of Anesthesi-
ologists (ASA) grades I–III. Since February 2004, 7 50 19 74

preoperative and postoperative self-assessed levels 8 53 65 33


of groin discomfort/pain have been recorded by 9 43 134 29
intent by each patient. 10 10 363
20 SUM 582 599 575
Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair
157 20
health report in the reception area, without contact an additional table showing the relative number of
with the surgeon. The postoperative SA question- patients assessing themselves at levels 8–10 (⊡ Ta-
naire was given to the patient at the time of release ble 20.2). Those with postoperative SA at levels 7
from the clinic, with information to send it back and below were offered clinical follow-up.
3 months later. The instrument consists of a visual To analyse the validity of data collected from the
10-box scale in which SA level 10 represents no dis- primary answers, a second request for postoperative
comfort and level 1 represents the worst pain. SA was sent 4–6 months after surgery to 55 patients
A secretary routinely saved patients’ SA registra- who did not answer the first questionnaire. Analysis
tions into a database. When opened, the database of difference by ordinal logistic regression showed
automatically displayed updated information in a no difference between the two groups (⊡ Fig. 20.2).
table, showing the number of patients at each level as
registered before and 3 months after surgery as well
as further numbers of patients who had moved an
Primary and secondary
individually calculated number of steps in positive
self-assessment answers
(improved) and negative (impaired) directions on 2
10-log rel number of answers at each level
the scale (⊡ Table 20.1). Furthermore, the updated
Primary answer
preoperative and postoperative information was 1.6 N=599
presented in two histograms (⊡ Fig. 20.1) and in y = 0.415x - 2.365
1.2 R 2 = 0.9906

0.8
⊡ Table 20.2. Means and medians for preoperative Secondary
and postoperative self-assessment (SA) 3 months after answer
0.4 N=55
open hernia repair (level 10 denotes no discomfort).
y = 0.468x - 2.843
Fractions of patients rating themselves at level 8 and
0 R 2 = 0.9119
higher before and after surgery are indicated. The dif-
ference indicates the mean number of levels that the 1 2 3 4 5 6 7 8 9 10 11
patients changed their rating from their preoperative Assessment levels
to their postoperative SA
⊡ Fig. 20.2. Diagram demonstrating the similarity between the
Preop Postop Difference postoperative ratings from patients without reminders (primary
answers, squares) and the ratings from patients after a reminder
Mean 4.877622 9.292020 4.397163
1 month later (secondary answers, diamonds) at 4 months. The
Median 5 10 5 difference as analysed by logarithmic regression was not sta-
tistically significant. Data are presented as 10-logaritms of the
Fraction>=8 18.2% 93.7%
relative number of patients at self-assessment levels 7–10

400

350

300

250
Preop
200 ⊡ Fig. 20.1. Distribution of patients
Postop
on the 10-level box scale in which 1
150
denotes the worst imaginable pain
100 and 10 denotes no discomfort. White
bars represent preoperative self-as-
50
sessments 1–4 weeks before surgery
0 (n=582), and black bars represent the
1 2 3 4 5 6 7 8 9 10 postoperative rating 3 months after
open hernia repair (n=599)
158 Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair

Patients Statistical Methods

During the years 2004–2006, 1,439 hernias in 1,369 Data are presented as means with standard de-
patients with unilateral and bilateral (8% of case viation. For continuous data, Student’s t-test was
series) inguinal hernias were operated upon. The used. Two-tailed probability of less than 5% (p-
operations were almost exclusively performed as value <0.05) was considered statistically signifi-
day surgery under general anaesthesia. Anaesthesia cant. Differences in ordinal data in the 10-box SA
was induced and maintained with propofol and scale were analysed with ordinal logistic regression
remifentanil. Ventilation was controlled with a la- (Minitab 15 software).
ryngeal mask. One surgeon performed 92% of the
operations, and 10 consultants performed the ad-
ditional 109 operations. Preoperative SA was ob- Results
tained from all patients except for a few with mental
disorders. All male, female (8.4%), and recurrent Self-Assessment in the Register
(6.1%) inguinal hernia patients were included in the Information
register. The report is based on 562 patients who,
without notice, returned their 3-month SA (41%). Distributions of SA levels prior to surgery and
Missing data necessary for comparing preoperative 3 months after the operation are shown in ⊡ Fig. 20.1.
and postoperative ratings were noted in 21 cases. At 1–4 weeks before surgery, the distribution of pa-
Mesh procedures dominated in primary ingui- tients on the scale shows a peak at level 3 with a
nal hernia surgery (77%). Single-plug procedures mean at level 4.9 (⊡ Table 20.2). Ten patients (1.7%)
(12.8%) were restricted to small medial herniations had no pain before surgery, and 36 (6.2%) regis-
with a well-defined hernia neck (low Spigeli hernia- tered the worst imaginable pain (⊡ Table 20.1). At
tion). A combination of plug and mesh was used in 3 months after surgery, the mean SA level in the
Nyhus IIIb hernias with large defects at the internal whole set of information was 9.3, and the mean
orifice and in large sliding hernias. In total, prosthe- number of improvement steps was 4.4 after the per-
ses were used in 484 cases (89%). Suture reinforce- formed surgical procedures (⊡ Table 20.2).
ment of the inner inguinal orifice (annulorraphy) The distribution of improvement in the whole
with additional strengthening of the dorsal wall set of information is shown in ⊡ Table 20.1 and
(11%) was used in young individuals, including fer- ⊡ Fig. 20.3. The majority of cases, 537 out of 575
tile females, in whom sutures towards the inguinal (93.4%), changed in a positive direction on the
ligament aligned with the strong internal oblique SA scale. Twenty-nine patients (5%) had the same
muscle. Calculations are based on 484 and 57 cases preoperative and postoperative SA level, mainly at
with prosthesis and suture repair, respectively. levels 8–10. Nine cases were impaired (1.6%). The

n
90
80
⊡ Fig. 20.3. This diagram is based 70
on column B in Table 20.1 and 60
demonstrates the number of pa- 50
tients in relation to the number of
40
steps in a positive or negative di-
30
rection corresponding to the level
of self-assessed improvement or 20
impairment (-) between the pre- 10
operative and postoperative rat- 0
20 ings. The y-axis shows the number
of patients
-9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6
Difference between pre- and postoperative SA
7 8 9
Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair
159 20
relative number of patients who rated themselves Only in sutured repair were no postoperative
without discomfort changed from 1.6% (n=10) pre- discomfort registrations below level 7 observed.
operatively to 60.6% (n=363) postoperatively. In other subgroups–i.e. all unilateral and bilateral
cases, all male and female cases, and prosthe-
sis cases–assessments lower than 7 were found
Improvement with Regard to Gender (⊡ Figs. 20.4 and 20.5).
and Type of Repair

There was no significant difference in mean im- Postoperative SA Distribution Slope


provement levels between suture and prosthesis
repair, in male versus female patients, or in uni- The relationship between the number of pa-
lateral versus bilateral cases (⊡ Table 20.3). Bilateral tients and the degree of discomfort as reported
suture repair (performed in men only) showed the at 3 months appeared to form a slope that might
lowest improvement, 2.83±2.13 steps on the scale, fit an exponential function (⊡ Fig. 20.6). To test
whereas the largest step was observed in unilateral this, the total number of cases at each SA level in
suture repair, 4.76±2.50 (⊡ Table 20.3). the 10-box SA scale was transformed to a relative

35 350
30 300
25
Female patients Male patients
250
20 Preop 200 Preop
15 Postop 150 Postop
10 100
5 50
0 0
1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10

⊡ Fig. 20.4. Distribution of preoperative and postoperative self-assessment among female and male patients. There was no dif-
ference as calculated with ordinal logistic regression, p=0.884

40 350

35 300
30
Suture repair Prosthesis repair
250
25
Preop 200 Preop
20
Postop 150 Postop
15
10 100
5 50
0
0
1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10

⊡ Fig. 20.5. Distribution of preoperative and postoperative self-assessment after suture and prosthesis repair, respectively.
There was no significant difference as calculated with ordinal logistic regression, p=0.099. Note the presence of cases in the
lower part of the scale after prosthesis repair compared with suture repair, for which no postoperative registration lower than
level 7 was found
160 Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair

⊡ Table 20.3. Mean (standard deviation, number) improvement steps in the 10-box self-assessment scale 3 months
after open inguinal hernia surgery following suture or prosthetic repair, respectively. There was no significant difference
between the improvement steps as calculated from the register data, nor between genders, nor between types of repair.
Bilateral suture repair (in males only) showed the lowest mean improvement level, 2.83 steps, but showed no significant
difference compared with unilateral suture repair, p=0.12, or bilateral prosthesis repair, p=0.19

Gender Suture repair Prostheses


Unilateral Female 4.21±2.34 (n=24) 3.95±2.01 (n=23)
Male 4.76±2.50 (n=27) 4.43±2.60 (n=420)
Bilateral Male 2.83±2.13 (n=6) 4.31±2.57 (n=41)

All inguinal hernia operations 2004-2006


390
363
340
290
Number of patients

240
190
140
134
90
65
40
9 19
0 2 1 2 4
⊡ Fig. 20.6. Number of patients at -10
each self-assessment level on the 10- 1 2 3 4 5 6 7 8 9 10
level scale Self-assessment levels

All inguinal hernia operations 2004-2006 number (percent) followed by calculation of the
1.9 10-logarithm of the relative number. The 10-log-
arithms were correlated to corresponding assess-
1.7
ment levels in a diagram, and a straight line was
10-log rel number at each self

1.5 formed, R2=0.9948 (⊡ Fig. 20.7).


1.3
assessment level

1.1 y = 0.406x - 2.284


2
R = 0.9946 Discussion
0.9
0.7
Analyses of the register data create hypotheses
0.5 rather than answering them. In contrast to ran-
0.3 domised studies, however, they reflect the whole
0.1 case mix. In routine clinical quality control on the
basis of postal follow-up, only a fraction of the pa-
-0.1 0 2 4 6 8 10 tients can be expected to return the first question-
Self-assessment level naire. This is a weakness that can be defended only
by a large number of cases and analysis of answers
⊡ Fig. 20.7. Relationship between 10-log of the relative num-
ber of cases in each self-assessment (SA) level and the cor-
after a second request. Results of such analysis in
the present paper indicate a close similarity be-
20 responding SA level. A straight line with R2 =0.9948 indicates
a strong correlation tween first and second answers. It can therefore be
Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair
161 20
assumed that the collected register data are repre- wards the surgical trauma. This variation among
sentative for the register population. the surgical patients probably includes both vary-
There was a distinct difference in the distribu- ing inflammatory reaction to the surgical trauma
tion of SA levels in the preoperative scale compared and prostheses, when present, as well as genetically
with postoperative ratings. The preoperative as- determined variation in sensitisation mechanisms
sessments were rather evenly distributed along the [9]. The gender similarity indicates a common
scale, with relatively low frequency at the extremes genetic variation of pain propensity between the
and with a more pronounced peak at level 3. The sexes.
centre of the scale, level 5, divided the preoperative There was no significant difference in the
assessments into two equal parts. Only 10 out of number of improvement steps after prostheses
582 patients, 1.7%, reported no discomfort prior placement or suture hernia repair. This indicates
to surgery. This indicates that pain in addition to that pain reaction to the surgical trauma seems to
the inguinal herniation is a significant problem for be a stronger pain determinant than the additional
the patient. presence of a prosthesis. This is in concordance
In contrast, the postoperative ratings formed a with previous observations in young males [10].
linear-curve distribution along the scale. The slope It was observed, however, that after suture repair,
was strictly fitted to an exponentially defined func- no patient indicated more discomfort than that
tion, with approximately 60% of the cases report- associated with level 7 on the scale, in contrast to a
ing no discomfort, i.e. level 10 at 3 months. The re- number of patients receiving prostheses who rated
maining number of patients with slight discomfort themselves as having stronger pain. The number of
to severe pain (approximately 40%) is similar to cases with this important qualitative difference in
that observed in a Scottish study in which 43% had their postoperative SA is probably too low to create
mild and 3% severe pain at 3 months [8]. a significant difference between the latter groups.
The contrast between preoperative and post- Only a minor number of the 40% of patients
operative SA levels (⊡ Fig. 20.8) reflects the wide who indicated some discomfort had a stronger
variation of self-assessed discomfort/pain in a pain reaction. Most of them indicated light dis-
nonrandomised register group as compared with comfort at levels 9 and 8 at 3 months. One hypoth-
the intention-to-treat situation following a highly esis raised after these observations is that the part
standardised surgical treatment. If one assumes of the scale that covers levels 7–10 may represent
only minute variations in surgical performance of individual variation in sensitivity to the surgical
the Lichtenstein repair as performed by one sur- trauma. The strict exponential distribution in the
geon in several hundreds of patients, the observed patient population of pain assessment in this part
SA slope in the scale may primarily be explained of the scale may support this interpretation. Pa-
by individual variation in reaction patterns to- tients with SA levels in the lower part of the scale,

10
9.8
Mean of postoperative self-

9.6
assessment

9.4
9.2
9
⊡ Fig. 20.8. Diagram demons-
8.8 trating the gradual reduction
8.6 in postoperative assessment
8.4 of pain/discomfort (mean) in
relation to preoperative self-
1 2 3 4 5 6 7 8 9 10
assessment. Level 10 denotes
Preoperative self-assessment no discomfort
162 Chapter 20 · Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair

levels 1– 6, additionally expressed the presence Discussion


of a stronger pain component associated with the
use of mesh or plug prostheses, as observed in the Kehlet: You suggested that there was a difference
present register. To reach a closer understanding of in pain compliance comparing mesh repair and
these possibly diverse pain mechanisms, the varia- suture repair. You may remember that we have col-
tion of discomfort/pain must be analysed over a laboration between the Danish and Swedish Her-
longer time frame. nia Data base with a very detailed questionnaire
that also compared young male who are at highest
risk with Shouldice repair and Lichtenstein repair.
References And in 2000 patients there were no differences
between this two techniques regarding chronic
1. Mikkelsen T, Werner MU, Lassen B, Kehlet H (2004) Pain inguinal pain.
and sensory dysfunction 6 to 12 months after inguinal
Smeds: I think that there is no difference for the
herniotomy. Anesth Analg 99:146–151
2. Massaron S, Bona S, Fumagalli U, Battafarano F, Elmore U,
majority of patients. But in this database there
Rosati R (2007) Analysis of post-surgical pain after ingui- were only a few patients who have had mesh
nal hernia repair: a prospective study of 1,440 operations. repair. I think that in case of suture repair the pa-
Hernia 11:517–525 tients have had comparable postoperative pain in
3. Ringkamp M, R Meyer (2006) Does peripheral sensitiza-
general. Only some of them have had more pain,
tion of primary afferents play a role in neuropathic pain?
In: Campbell JN, et al. (eds) Emerging strategies for the
what may be related to a nerve lesion.
treatment of neuropathic pain. IASP Press, Seattle, pp Hopf: Have you investigated whether there is a
8–102 difference regarding postoperative pain comparing
4. Matthews RD, Anthony T, Kim LT, Wang J, Fitzgibbons RJ local to general anesthesia? Did any of the patients
Jr, Giobbie-Hurder A, Reda DJ, Itani KM, Neumayer LA;
get ketamin, because there are some data that sug-
Veterans Affairs Cooperative 456 Studies Program Investi-
gators (2007) Factors associated with postoperative com-
gested that patients who get ketamin are of high
plications and hernia recurrence for patients undergoing risk to develop postoperative pain.
inguinal hernia repair: a report from the VA Cooperative Smeds: All patients were operated using local an-
Hernia Study Group. Am J Surg 194:611–617 esthesia. And we never used ketamin in our pa-
5. Gordh T, Chu H, Sharma HS (2006) Spinal nerve lesion
tients.
alters blood-spinal cord barrier function and activates
astrocytes in the rat. Pain 124:211–221
Schumpelick: In my opinion your main message
6. Tegeder I, Costigan M, Griffin RS, et al. (2006) GTP cyclohy- is, that you have a relation of age and pain. Why is
drolase and tetrahydrobiopterin regulate pain sensitivity it so? Is it because of the nerve function? Is it the
and persistence. Nat Med 12:1269–1277 tolerance to pain? Is it experience of the patients?
7. Salcedo-Wasicek MC, Thirlby RC (1995) Postoperative
Smeds: We have to listen to those colleagues who
course after inguinal herniorrhaphy. A case-controlled
comparison of patients receiving workers’ compensa-
are working on the problem of dorsal ganglion
tion vs patients with commercial insurance. Arch Surg routes. May be there are mutations in the gene that
130:29–32 processes the enzyme that forms the tetrahydro-
8. Courtney CA, Duffy K, Serpell MG, O’Dwyer PJ (2002) biopterine. This is the first hint that there may be
Outcome of patients with severe chronic pain following
a genetically determined level of pain. I think that
repair of groin hernia. Br J Surg 89:1310–1314
9. Tegeder I, Adolph J, Schmidt H, Woolf CJ, Geisslinger G,
we will get much more information about the pro-
Lötsch J (2008) Reduced hyperalgesia in homozygous cess of pain, and I think that it is individually dif-
carriers of a GTP cyclohydrolase 1 haplotype. Eur J Pain ferent. However, I think that the preoperative pain
12:1069–1077 score is very important to identify those patients
10. Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H; Swedish Her-
who are of high risk of developing postoperative
nia Data Base; the Danish Hernia Data Base (2004) Chronic
pain after open mesh and sutured repair of indirect ingu-
pain.
inal hernia in young males. Br J Surg 91:1372–1376

20
21

Chronic Pain After Inguinal


Hernia Repair
H. Kehlet, E. K. Aasvang
164 Chapter 21 · Chronic Pain After Inguinal Hernia Repair

Introduction
Preop. pain
21 intensity
There is now general agreement, based on data
from randomised trials comparing different surgical
techniques and larger amounts of epidemiological
Genetics Psyche
data, that chronic pain influencing daily activities
may occur in 5–10% of patients [1–5]. Because little
scientific data exist on evidence-based treatment
of persistent postherniotomy pain, this undesirable
outcome probably represents the most important Acute Surgical
one for improvement in groin hernia repair. postop. pain trauma
The main focus for future research on the
pathogenesis and treatment of chronic post-
herniotomy pain is the role of patient-related ver- Nerve injury
sus surgery-related factors [5] (⊡ Fig. 21.1). This
report gives a short update on recent developments
concerning the pathogenic mechanisms listed in ⊡ Fig. 21.1. Pathogenic mechanisms of persistent pain after
groin hernia repair
⊡ Fig. 21.1. Other factors such as age (decreased
risk of chronic pain), female gender, and surgery
for a recurrent hernia are other well-documented
risk factors [3]; however, these cannot be altered. cation into different risk groups when comparing
different surgical techniques or pharmacological
interventions.
Preoperative Pain

The preoperative intensity of groin pain is a well- Psychological Factors


documented risk factor for developing a persistent
pain state [1, 3, 6] and corresponds to a similar Preoperative anxiety and depression are well-
documented risk following other surgeries [7]. known characteristics of patients with chronic
Importantly, remote preoperative pain–i.e., pain nonmalignant pain and have been demonstrated
in parts of the body other than the groin–has to be risk factors for acute pain states [7]. However,
also been demonstrated to correlate with persistent in pain after groin hernia repair, depression and
pain, both in groin hernia repair [6, 8, 9] and other anxiety were present in few (about 5%) patients
operations [7, 10]. These findings suggest that the [11] and may therefore not be considered impor-
preoperative functional level of the nociceptive tant risk factors compared with other postsurgical
system is an important risk factor, and several persistent pain states in which malignancy, ampu-
studies have shown a positive correlation between tation, etc., may contribute to impaired psychoso-
the pain response to a preoperative nociceptive cial functioning. Nevertheless, preoperative assess-
stimulus (heat, electrical, cold) [7] and the acute ment of anxiety and depression should be included
postoperative pain response, which otherwise has in future high-level scientific studies on chronic
been demonstrated to correlate with the risk of postherniotomy pain.
developing a persistent pain state [1, 7].
In summary, preoperative pain states and the
level of nociceptive function are well documented Acute Postoperative Pain
as being important risk factors for developing a
persistent pain state. They should therefore be As mentioned above, in several operations, in-
included and assessed in all future pain trials, cluding groin hernia repair, a well-documented
thereby providing possibilities for patient stratifi- relationship exists between the intensity of the
Chapter 21 · Chronic Pain After Inguinal Hernia Repair
165 21
acute postoperative pain response and the risk [11]. These findings confirm that nerve damage
of developing persistent pain [7]. For example, a may be a prerequisite for developing a persistent
large consecutive series with well-defined multi- pain state after groin hernia repair. However, cor-
modal preemptive analgesia (including local an- responding to findings from other surgical proce-
aesthesia, nonsteroidal anti-inflammatory drugs, dures [7], factors other than nerve damage, includ-
and paracetamol) showed a threefold higher risk ing genetic factors, may contribute to persistent
of chronic pain for patients with moderate to se- pain (see below).
vere early postoperative pain compared to those All future studies on persistent pain after groin
with no or low-intensity acute postoperative pain hernia repair should include preoperative and
[12]. Consequently, these and other findings [7] postoperative detailed neurophysiological assess-
have led to the hypothesis that improved early ment in order to evaluate the relative importance
postoperative pain treatment may reduce the risk of different pathogenic mechanisms. This is espe-
of chronic pain (the concept of preemptive an- cially important for all studies comparing different
algesia). However, so far the data are negative surgical techniques such as laparoscopic versus
[7] and instead seem to suggest that the acute open repairs, type of mesh, fixation techniques,
postoperative pain response is determined by the and so on.
preoperative function of the nociceptive system,
and thereby also the risk of persistent pain. Nev-
ertheless, there is a need for further randomised Surgical Trauma
studies, with more effective and prolonged acute
pain treatment, on the risk of developing a persis- As mentioned above, surgical injury to one or all
tent pain state. of the three groin nerves may occur frequently,
although all efforts should be made to identify
and preserve these nerves, as discussed in other
Nerve Injury chapters in this book. Consequently, the surgical
technique may be important for preventing or
A main pathogenic mechanism for persistent post- reducing a persistent pain state. However, so far
surgical pain states is intraoperative nerve injury the literature is not entirely conclusive regard-
[7]. Obviously, with the three nerves passing the ing laparoscopic versus open repair, type of mesh
surgical field in groin hernia repair, there is a sig- (composition, lightweight versus heavyweight),
nificant risk of nerve injury. Several studies have and different fixation techniques. One reason may
previously reported numbness after groin hernia be that for each of these topics the other variables
repair; unfortunately, these reports did not use have not been well described, which especially ap-
well-described, specific assessments of sensory dis- plies to studies comparing laparoscopic and open
turbances as a sign of nerve injury, thereby limit- repairs. Ideally, the risk of nerve injury should
ing interpretation. This also includes studies com- be reduced in laparoscopic repair without mesh
paring laparoscopic versus open repairs. A recent fixation–but most reports have insufficiently de-
detailed study using the gold standard quantitative scribed the fixation technique and its risk in terms
sensory assessment (QST) [11] in patients with of nerve injury.
and without persistent groin hernia pain, includ- Prospective ongoing studies that include all
ing patients who had bilateral repair, demonstrated risk factors (preoperative, intraoperative, and
that persistent postoperative sensory dysfunctions postoperative) in collaboration with Copenhagen
had a very low specificity for chronic pain, indi- and Stuttgart and with detailed QST assessments
cating that nerve damage occurs often, even in have completed patient inclusion and 6 months of
patients without chronic pain. However, signs of follow-up. It is hoped that the data will be able to
neuroplasticity with more frequent and intense clarify the effects of high-expertise laparoscopic
pain after repetitive punctuate and brush stimula- repair without mesh fixation versus high-expertise
tion were observed only in chronic pain patients open Lichtenstein repair.
166 Chapter 21 · Chronic Pain After Inguinal Hernia Repair

In summary, there is no doubt that the surgi- in the large number of studies with chronic pain
21 cal technique is important for avoiding the risk of as an outcome [5]. Such characterisation must also
nerve damage, especially when mesh may cause be included in future trials on pharmacological
compression of the nerves [13, 14]. Future trials treatment [7] as well as in studies on surgical treat-
are called for, and they need to include high-qual- ment with neurectomy and mesh removal [14] and
ity assessment of the signs of nerve damage when where preliminary data with detailed neurophysi-
comparing different techniques. ological characterisation and functional outcomes
suggest such techniques to reduce chronic pain in
some, but not all, patients [18].
Genetic Factors

Based on the findings from a variety of surgical References


procedures, only a fraction of patients with docu-
mented intraoperative nerve injury develop a per- 1. Aasvang E, Kehlet H. Chronic postoperative pain: the case
of inguinal herniorrhaphy. Br J Anaesth 2005; 95:69–76
sistent pain state [7, 11]. Recent studies with geno-
2. Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H,
type characterisation have suggested that COMT Bleichrodt R. Chronic pain after mesh repair of inguinal
genes are important for pain sensitivity [15] and hernia: a systematic review. Am J Surg 2007; 194:394–400
that GTP-cyclohydrolase regulates pain sensitivity 3. Franneby U, Sandblom G, Nordin P, Nyren O, Gunnarsson
in normal subjects and pain-related outcomes after U. Risk factors for long-term pain after hernia surgery. Ann
Surg 2006; 244:212–219
spinal surgery [16]. Genes controlling the function
4. Ferzli GS, Edwards E, Al-Khoury G, Hardin R. Posthernior-
of the voltage-gated sodium channel are also im- rhaphy groin pain and how to avoid it. Surg Clin North Am
portant [15]. Although this is a developing field of 2008; 88:203–209
pain research, all future high-level scientific stud- 5. Kehlet H. Chronic pain after groin hernia repair. Br J Surg
ies on persistent groin hernia pain should include 2008; 95:135–136
6. Wright D, Paterson C, Scott N, Hair A, O’Dwyer PJ. Five-
characterisation of the genetic architecture of pain
year follow-up of patients undergoing laparoscopic or
perception to provide further understanding of the open groin hernia repair: a randomized controlled trial.
mechanisms and risk factors for persistent groin Ann Surg 2002; 235:333–337
hernia pain. Unfortunately, no data are available 7. Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain:
so far. risk factors and prevention. Lancet 2006; 367:1618–1625
8. Courtney CA, Duffy K, Serpell MG, O’Dwyer PJ. Outcome
of patients with severe chronic pain following repair of
groin hernia. Br J Surg 2002; 89:1310–1314
Summary 9. Aasvang EK, Mohl B, Bay-Nielsen M, Kehlet H. Pain rela-
ted sexual dysfunction after inguinal herniorrhaphy. Pain
The pathogenic mechanisms of chronic pain after 2006; 122:258–263
10. Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen
groin hernia repair are definitely of multifactorial
TS. Risk factors for chronic pain after hysterectomy: a
origin [5], and previous efforts to classify the syn- nationwide questionnaire and database study. Anesthesi-
dromes into neuropathic versus nonneuropathic ology 2007; 106:1003–1012
(inflammatory) pain [17] may not be founded on 11. Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Keh-
clear-cut diagnostic criteria. Thus, nerve injury let H. Neurophysiological characterization of posthernio-
tomy pain. Pain 2008; 137:173–181
after groin hernia repair occurs very frequently
12. Callesen T, Bech K, Kehlet H. Prospective study of chronic
but leads to a chronic pain state in only a fraction pain after groin hernia repair. Br J Surg 1999;86: 1528–
of patients. However, since nerve injury seems to 1531
be a prerequisite for developing persistent pain, all 13. Demirer S, Kepenekci I, Evirgen O, Birsen O, Tuzuner A,
efforts should be made to develop and character- Karahuseyinoglu S, Ozban M, Kuterdem E. The effect of
polypropylene mesh on ilioinguinal nerve in open mesh
ise surgical techniques to avoid peripheral nerve
repair of groin hernia. J Surg Res 2006; 131:175–181
injury. It is hoped that future studies will include a 14. Amid PK, Hiatt JR. New understanding of the causes and
complete characterisation of all pathogenic mech- surgical treatment of postherniorrhaphy inguinodynia
anisms–something that has not happened before and orchalgia. J Am Coll Surg 2007; 205:381–385
Chapter 21 · Chronic Pain After Inguinal Hernia Repair
167 21
15. Diatchenko L, Nackley AG, Tchivileva IE, Shabalina SA, O’Dwyer: Any statements regarding the fact that
Maixner W. Genetic architecture of human pain percep- every patient with chronic pain has some sort of
tion. Trends Genet 2007; 23:605–613
sensory deficit? What is your experience with tes-
16. Tegeder I, Costigan M, Griffin RS, Abele A, Belfer I, Schmidt
H, Ehnert C, Nejim J, Marian C, Scholz J, Wu T, Allchorne A, ticular pain, because 15% of our patients develop
Diatchenko L, Binshtok AM, Goldman D, Adolph J, Sama S, specific testicular pain?
Atlas SJ, Carlezon WA, Parsegian A, Lotsch J, Fillingim RB, Kehlet: Specific testicular pain is quite rare. But we
Maixner W, Geisslinger G, Max MB, Woolf CJ. GTP cyclohy- have not analyzed it in the current study. However,
drolase and tetrahydrobiopterin regulate pain sensitivity
we have to do this statistical comparison, because
and persistence. Nat Med 2006; 12:1269–1277
17. Loos MJ, Roumen RM, Scheltinga MR. Classifying posther- we included all this data in our data base.
niorrhaphy pain syndromes following elective inguinal Song-Zhang Ma: Chronic pain is a severe prob-
hernia repair. World J Surg 2007; 31:1760–1765 lem. In China inguinal hernia repair using mesh
18. Aasvang EK, Kehlet H. The effect of mesh removal and materials is performed 150.000 times per year. But
selective neurectomy on persistent postherniotomy pain.
so far I have just a very few reports on postopera-
Ann Surg 2009; 249:327–334
tive pain. What do you think is the reason? Is this
because of the tolerance of pain?
Kehlet: There could be several explanations. One
Discussion could be that patients in China have a different
genetic profile. Another reason could be that you
Deysine: Within the population that I operated really have not asked your patients about discom-
there were a lot of young people for instance teenag- fort and postoperative pain. We have had this
ers. Within this population there was a lot incidence hernia meeting several times before, and we have
of drug intake before surgery. In my opinion this never talked about chronic postoperative pain. We
is an important factor in developing postoperative didn’t talk about it because we didn´t realized such
pain. Did you consider such things in your study? problems.
Kehlet: We know that the management of acute Song-Zhang Ma: I totally agree. Before the opera-
pain is very difficult in such patients. However, I tion we talk about recurrence and infection, but we
have never seen such a problem of drug addiction didn’t talk about chronic postoperative pain in
in patients operated because of an inguinal hernia. detail.
We don´t have such patients in Denmark, but I Amid: Few patients following inguinal hernia re-
think that this could be a risk factor as well. pair develop specific testicular pain. We did an
Schumpelick: Could you give us some more re- investigation that this problem could be related to
marks about »pain genes«. This seems to be a very the fact that the nerves were involved in the lamina
new story and we want to know a little bit more propria of the vas deference. We have just 12 cases,
about that. therefore it is not enough to make a conclusion,
Kehlet: I showed you the references of the two best but it is a very significant finding.
candidates that may be important »pain genes«. Kehlet: I agree.
In mouse and rat studies there were a lot of more Schumpelick: Is there a correlation between in-
possible candidate genes. But the two mentioned come and development of postoperative pain?
genes are the only genes that were also found to be Kehlet: There are many factors to consider, how-
of interest in humans. One of it was found in fac- ever actually I cannot comment on this. But this is
tory workers who were analyzed for chronic man- the reason why we should have a detailed charac-
dibular pain. And after some years they could pre- terization of our patients.
dict those who are of risk to develop this chronic
pain syndrome. But what we have to do in the
future is to combine all the different characteristics
of all »pain genes«. At the moment we were at an
early stage we have not enough information that it
would be relevant for clinical praxis.
22

What Do We Know About the


Pathophysiology and Pathology
of Neuropathic Pain?
P. L. Jansen, K. Bas, D. Kämmer
170 Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?

Introduction tion of nerves due to mesh-induced foreign body


reaction. For the latter, surgical intervention can be
After hernia surgery, severe chronic pain is re- successful. In contrast, neuropathic pain is associ-
22 ported in up to 10% of the patients. The treatment ated with irreversible neuronal changes; therefore,
of these patients using neurectomy, mesh explanta- surgical treatment by neurectomy or mesh explan-
tion, and symptom control by administration of tation may be insufficient [4].
analgesics frequently fails and hints at a neuro-
pathic pain syndrome, at least in a subgroup of
patients. Neuropathic pain syndromes are caused Pathophysiology of Neuropathic Pain
by irreversible changes of the nervous system.
For postoperative neuropathic pain, inflamma- Inflammation, degeneration of nerve fibers, repa-
tion as well as nerve degeneration and pathologi- ratory mechanisms of neural tissue, and the reac-
cal regeneration are the underlying pathological tion of the connective tissue lead to hyperexcit-
mechanisms that precede these central nervous ability in primary afferent nociceptors [2]. The
changes. Advances in understanding the periph- hyperactivity in nociceptors that is called periph-
eral pathophysiological mechanisms are neces- eral sensitization induces secondary changes in
sary to develop sufficient tools for preventing and processing neurons in the spinal cord and brain
treating neuropathic pain. A pathophysiological that amplify the state of hyperexcitability and lead
reclassification could provide a new basis for tar- to central sensitization. Normally, these sensitiza-
geted and individualized therapy of patients with tion phenomena are limited until the tissue heals
chronic pain after hernia therapy. and the inflammation subsides. However, when
primary afferent function is altered permanently,
the state of hyperexcitability persists (⊡ Fig. 22.1).
Neuropathic Pain The resulting clinical signs are the spontaneous
pain, allodynia, and hyperalgesia that are charac-
Neuropathic pain is defined as chronic, not self- teristic for patients with neuropathic pain.
limiting pain that can occur after any lesion or A simple focal peripheral nerve injury causes
dysfunction of the peripheral or central nervous a variety of changes in the nervous system, which
system. In contrast to nociceptive and inflam- can all contribute to the persistence of pain and
matory pain, neuropathic pain has no protective abnormal sensation. We can observe changes in
function and arises by inadequate stimulation of the peripheral primary afferent neurons as well
the peripheral sensory endings [1]. Etiology-based as in the central nervous system. These changes
classifications of painful peripheral neuropathies include upregulation of sodium channels and spe-
include syndromes caused by generalized lesions cific receptors as well as synthesis and secretion of
of the peripheral nervous system (e.g., polyneu- cytokines and neurotransmitters, leading to ectopic
ropathies), complex neuropathic disorders (e.g., impulse generation, reduced activation threshold,
complex regional pain syndromes), and syndromes or increased synaptic transmission. At the central
caused by focal or multifocal lesions of peripheral nervous system, the loss of intraspinal inhibition
nerves (e.g., postsurgical pain syndromes) [2]. due to the death of inhibitory interneurons plays a
Based on this definition, we can expect neu- crucial role [2, 5].
ropathic pain after any surgical intervention, at These neuronal changes are independent from
least in a subgroup of patients, and even when the the underlying disease, and the same neuronal
operating field is in close proximity to peripheral mechanisms are responsible for neuropathic pain
nerves. Indeed, we can observe neuropathic pain after hernia repair as for other pain syndromes.
syndromes after Shouldice, Lichtenstein, and even Because several mechanisms can cause a specific
laparoscopic hernia repair [3]. Neuropathic pain has pain symptom, a combined therapy is often more
to be clearly separated from chronic pain caused by promising than a single one. Peripheral and central
neuroma formation following nerve injury or affec- neuronal changes are the common track for neu-
Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?
171 22

⊡ Fig. 22.1. Pathophysiology of neuropathic pain (BMI body mass index)

ropathic pain syndromes, but pathophysiological preliminary study, we investigated a potential role
changes at the site of peripheral nerve injury pre- of macrophages for neuropathic pain in hernia pa-
cede these neuronal changes. tients. In contrast to healthy nerves obtained from
pigs, infiltrating macrophages were frequently de-
tected in neurectomy specimens from hernia pa-
Inflammation in Neuropathic Pain tients with chronic pain (⊡ Fig. 22.2). The expres-
sion of matrix metalloproteinase 2 (MMP-2), a
Recent publications hint at a pivotal role of the pivotal mediator of macrophages, is also enhanced,
inflammatory reaction for the development of especially in the endoneurium. A role of MMPs in
neuropathic pain. After tissue injury, mast cells, the development of neuropathic pain after spinal
macrophages, T-cells, neutrophils, and Schwann nerve ligation was demonstrated recently in rats
cells are activated and infiltrate from endoneural and mice by Kawasaki et al. [8]. MMP-9 showed
blood vessels into the nerve (⊡ Fig. 22.2) [6]. They rapid upregulation in injured dorsal route gangli-
secrete huge amounts of cytokines, nerve growth ons, whereas MMP-2 was responsible for the late
factors, and proteases. These mediators induce ec- phase of neuropathic pain and was upregulated in
topic activity via receptor-mediated actions on af- primary afferent neurons as well as in the dorsal
ferent nerve fibers. Although the impact of nerve horn.
inflammation on neuronal changes has not been This study demonstrated for the first time
clarified in detail, it is known that the inflamma- that peripheral processes do not occur in isolation
tory reaction after nerve injury initiates and main- from central neuroinflammation. The separation
tains sensory abnormalities [2, 6]. between early-phase and late-phase neuropathic
Macrophages are key cells after nerve injury. pain mechanisms can lead to important clinical
Barclay et al. found that the depletion of mac- implications, such as the development of tools
rophages attenuates the mechanical hyperalgesia for preventing and treating neuropathic pain. Ka-
after peripheral nerve lesions in rats [7]. In a wasaki et al. [8] demonstrated that the develop-
172 Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?

22

⊡ Fig. 22.2. Immunohistochemistry of CD68 (macrophages) and MMP-2 in ilioinguinal nerve specimens from pigs and chronic
pain patients after hernia therapy. Magnification ×200

ment of pain hypersensitivity could be inhibited by nerves by compromising proper function of this
the administration of MMP inhibitors and small so-called perineurium. Additionally, the fibrotic
interfering RNA in MMP knockout mice. Inter- reaction can lead to obliteration of Schwann cell
estingly, a role of MMP-2 is also well known to tubes and block axon regeneration or lead to mis-
support mesh-induced chronic foreign body reac- sprouting of axons, resulting in the formation of
tion. Mesh implantation in animal models induces neuromas at the end of injured nerve fibers or
excessive MMP-2 gene transcription and activity even intraneurally. The extraneural conditions can
mediated by infiltrating macrophages, and this be successfully treated by surgical intervention.
pathway may also contribute to the development In contrast, the composition of the endoneu-
of neuropathic pain. rium can be disturbed after nerve injury. Salonen
et al. analyzed the fibrotic reaction after sciatic
nerve transaction in rats. They found increased
The Role of Fibrosis in Neuropathic expression of fibronectin and collagens, especially
Pain type III collagen in the endoneurium [9]. Similarly,
we could detect a distinct expression of type I and
Next to the inflammatory reaction, nerve injury type III in nerve specimens from chronic pain pa-
activates Schwann cells and fibroblasts. These cells tients (⊡ Fig. 22.3).
synthesize fibronectin and, later on, collagens and Although the impact of a disturbed endoneu-
are responsible for changes in the extracellular ronal collagen expression on neuronal changes is
matrix. The common understanding is that the not yet clarified, these changes may be involved in
fibrotic reaction around the nerve can affect nerve the induction of ectopic activity of injured primary
fibers and lead to the retraction or compression of afferent nociceptors as well as of spared fibers.
Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?
173 22

⊡ Fig. 22.3. Endoneural distribution of type I collagen (red) and type III collagen (green) in neurectomy specimens of chronic
pain patients after hernia therapy. Sirius red staining, magnification ×200

Furthermore, our preliminary data hint at an indi- Summary and Outlook


vidual reaction to nerve injury.
Inflammation, fibrosis, and neuronal regenera-
tion can lead to complex changes in the function,
The Impact of Risk Factors on Neuro- chemistry, and structure of neurons and glial cells.
pathic Pain These mechanisms are independent from the un-
derlying disease and can occur after any surgical
In some but not all patients, the nerve lesion trig- intervention, even after hernia therapy. Patient-
gers molecular changes in nociceptive neurons, related risk factors can be additional disturbing
which become abnormally sensitive and develop factors in the complex system of pain perception.
pathological spontaneous activity. Several studies Though major progress has been made in the
have shown that individual risk factors have an understanding of cellular and molecular changes af-
impact on the development of neuropathic pain. ter nerve injury, their relevance for the pathophysi-
Major risk factors are age younger than 40 years, ology of pain in neuropathies after hernia therapy
preexisting preoperative pain, severe postopera- has yet to be determined. A mechanism-based
tive pain, and male gender [10–14]. We confirmed approach for treating neuropathic pain provides
these results in patients who had mesh explanta- hope for safer and more specific therapies.
tion either because of chronic pain or reoperation
for hernia recurrence. In our cohort, we found
that age under 50 and body mass index less than 25 References
were significantly associated with chronic pain. To
determine the tissue reaction in these two groups, 1. Treede R-D, Jensen TS, Campbell JN, Cruccu G, Dostrovsky
we further analyzed the inflammatory reaction JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J:
Neuropathic pain: redefinition and a grading system for
and found that the young patients who were at
clinical and research purposes. Neurology 2008, 70:1630–
risk for developing chronic pain had significantly 1635
enhanced infiltration of macrophages after mesh 2. Baron R: Mechanisms of disease: neuropathic pain–a clini-
implantation compared with older patients. cal perspective. Nat Clin Pract Neurol 2006, 2:95–106
174 Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?

3. Franneby U, Sandblom G, Nordin P, Nyren O, Gunnarsson They focus on fibrosis, they focus on inflammation
U: Risk factors for long-term pain after hernia surgery. Ann or they focus on neuronal changes. Unfortunately
Surg 2006, 244:212–219
I have no personal experience of preoperative drug
4. Kehlet H: Chronic pain after groin hernia repair. Br J Surg
22 2008, 95:135–136 medication and the development of postoperative
5. Woolf CJ, Mannion RJ: Neuropathic pain: aetiology, sym- pain.
ptoms, mechanisms, and management. Lancet 1999, Deysine: You mentioned that there were patho-
353:1959–1964 logically changes in nerves occurring at this kind
6. Thacker MA, Clark AK, Marchand F, McMahon SB: Patho-
of surgery. But this would mean that the surgeon
physiology of peripheral neuropathic pain: immune cells
and molecules. Anesth Analg 2007, 105:838–847 physically contacts the nerves. Neurosurgeons par-
7. Barclay J, Clark AK, Ganju P, Gentry C, Patel S, Wother- ticularly touch nerves just with glass-electrodes.
spoon G, Buxton F, Song C, Ullah J, Winter J, Fox A, Bevan And we retract nerves while the operation and
S, Malcangio M: Role of the cysteine protease cathepsin S touch them with metal instruments. In my opin-
in neuropathic hyperalgesia. Pain 2007, 130:225–234
ion the physical contact to the nerves has to be
8. Kawasaki Y, Xu ZZ, Wang X, Park JY, Zhuang ZY, Tan PH,
Gao YJ, Roy K, Corfas G, Lo EH, Ji RR: Distinct roles of mat- avoided.
rix metalloproteases in the early- and late-phase develop- Lynen-Jansen: I totally agree. But I also think it is
ment of neuropathic pain. Nat Med 2008, 14:331–336 a lucky situation if you can avoid contact to a nerve
9. Salonen V, Lehto M, Vaheri A, Aro H, Peltonen J: Endoneu- physically. But injury to the nerves are also pos-
rial fibrosis following nerve transection. An immunohisto-
sible by stretching them, especially if you don´t see
logical study of collagen types and fibronectin in the rat.
Acta Neuropathol 1985, 67:315–321 them while the operation.
10. Kehlet H, Jensen TS, Woolf CJ: Persistent postsurgical pain: Kehlet: What you mentioned about continuous
risk factors and prevention. Lancet 367:1618–1625 development of chronic pain is in contrast to what
11. Aasvang E, Kehlet H: Chronic postoperative pain: the case we have published. In our studies the pain inci-
of inguinal herniorrhaphy. Br J Anaesth 2005, 95:69–76
dence increases. We have very few prospective data
12. Matthews RD, Anthony T, Kim LT, Wang J, Fitzgibbons Jr
RJ, Giobbie-Hurder A, Reda DJ, Itani KMF, Neumayer LA: concerning chronic pain however can you com-
Factors associated with postoperative complications and ment on your different findings.
hernia recurrence for patients undergoing inguinal hernia Lynen-Jansen: In my opinion these were only data
repair: a report from the VA Cooperative Hernia Study in case of mesh implantation. Additionally it was
Group. Am J Surg 2007, 194:611–617
a retrospective study and therefore it was not so
13. Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH,
Chambers WA: A review of chronic pain after inguinal easy to determine the time point when the pain
herniorrhaphy. Clin J Pain 2003, 19:48–54 occured exactly for the first time.
14. Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H, Köckerling: In case of a patient in later course after
Bleichrodt R: Chronic pain after mesh repair of inguinal an endoscopic hernia repair, you have to watch
hernia: a systematic review. Am J Surg 2007, 194:394–
carefully for a recurrence or another morphologi-
400
cal reason for the pain. I have never seen a patient
with chronic pain without a morphological cause
of chronic pain.
Discussion Lynen-Jansen: I totally agree, again this study has
its natural limitations because it was a retrospec-
Penkert: Do you agree that we have no data that tive study.
a certain number of patients develop neuropathic Smeds: Do you have any biological data that would
pain? And please comment on what has been men- explain the correlation between pain and age?
tioned before: Influences the kind of preoperative Lynen-Jansen: At the moment we just have the
drug medication – especially morphium like medi- preliminary immunohistochemical investigations
caments – the incidence of chronic postoperative and therefore no satisfying answer for your ques-
pain following groin hernia repair? tion. But we have some data that the inflammatory
Lynen-Jansen: I totally agree. In the literature con- reaction in young patients is different compared
cerning the pathophysiology of neuropathic pain, to elder patients. A lot of biological reactions in
the authors focus on just one special mechanism. younger people are more aggressive, even the in-
Chapter 22 · What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain?
175 22
flammatory reaction. But the main question is,
why do some young patients develop postoperative
chronic pain and why other not. The answer could
be that we have a multifactorial impaired disease.
Stumpf: I want to comment on your immunohis-
tochemical data and on what Dr. Deysine said. It is
not a problem of how to handle the nerve, because
we did this investigation in nerves that we have
never touched before explanation. We explanted
the nerves in case of retroperitoneal neurectomies.
In my opinion it is rather a preexisting disorder
than a consequence of a physical never contact.
Schumpelick: Are there any differences comparing
the two groups in getting a recurrence of develop-
ing postoperative chronic pain?
Lynen-Jansen: In case of the explanted mesh mate-
rial we saw significant differences in the infiltra-
tion of macrophages in patients with chronic pain.
Franz: If you exclude the patients with a recur-
rence, where did you get the nerves from in the
pain free patients?
Lynen-Jansen: The two mentioned studies were
completely different.
23

Surgical Trauma of Nerves–Causes


of Neuropathic Pain, Classification,
and Options in Surgical Therapy
G. Penkert
178 Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain, Classification, and Options in Surgical Therapy

Introduction segments have a typical group arrangement with


three to five or more groups of fascicles. Closer
With the introduction of microsurgical methods and closer to the periphery, these groups further
applied to peripheral nerve lesions such as entrap- subdivide into many small single fascicles. This
ment syndromes, pseudoneuroma, and neuroma special multifascicular structure is the one we also
formations, as well as lesions with nerve discon- find within the often painful inguinal nerves, in-
23 tinuity, the results of nerve surgery have signifi- cluding the iliohypogastric, ilioinguinal, and gen-
cantly improved over the last three to four decades. itofemoral nerves.
But no real mental connection exists between these Following nerve damage or even transection,
successful microsurgical methods for improving or all of the elements constituting the nerve fiber,
even restoring nerve function and theories of the axon, and myelin sheath degenerate from the level
origin of neuropathic pain. This type of hardly of the lesion to the periphery. Our surgical efforts
treatable and, until now, not fully explained pain now normally aim at establishing the best condi-
often causes complete social disintegration of the tions as possible so that these axons can sprout
patient. again into the periphery and achieve their former
By means and results of microsurgery, we were targets. Unfortunately, reconstructions of those
encouraged to apply these surgical improvements multifascicular and small nerves have tended to re-
to pain related to nerve trauma, but we faced limi- sult in secondary neuromas at the coaptation sites;
tations that were difficult to overcome until today. the reason was aberration of all the small fascicles
Experiences in neuromodulation continue to offer at the coaptation site because of technical difficul-
new aspects, and quite recent reports on intraab- ties despite magnification under the microscope.
dominal laparoscopic neuromodulation even seem
to offer a solution to painful pelvic nerves.
Types and Degrees of Nerve Lesions

Microscopic Anatomy of the Peripheral As the result of destructive effects on nerve tissue,
Nerve System we can distinguish between lesions with and with-
out loss of continuity. In almost all cases, the ques-
We regard the nerve axon as the smallest anatomi- tion of continuity of the involved nerve remains
cal unit. The myelin sheath and its Swann cells unanswered. Two systems were therefore devel-
are located around the axon membrane. These oped to describe the potential degrees of nerve
structures are enclosed in two or more layers: tissue lesion.
one layer with latticed and the other with longi- In 1943, Seddon established the concepts of
tudinal collagen and elastic fiber elements–the neurapraxia, axonotmesis, and neurotmesis accord-
endoneurium. A certain number of such nerve ing to the degree of destructive forces on the nerve
fibers together with their individual endoneural tissue [18]. Neurapraxia refers to myelin sheath
sheath are again surrounded by connective tissue– degeneration within the affected nerve segment.
the perineurium. Again, a certain number of such Axonotmesis is defined as a complete interruption
bundles (fascicles) are grouped parallel to each of the axon’s continuity. Neurotmesis, in contrast to
other, and they are again surrounded by connec- the other types of lesion, means a complete nerve
tive tissue–the epineurium. interruption. Cases of neurapraxia recover within
This group arrangement within peripheral a few weeks if the forces that compress the nerve
nerves changes its distribution from central levels are removed. Cases of axonotmesis recover within
to the periphery. Additionally, individual cross- several months depending on the distance between
connections between these fascicles and groups lesion and target. Cases of neurotmesis cannot re-
of fascicles exist. Nerve roots consist of few but cover, and the targets remain paralyzed.
thicker fascicles divided into sectors by small But the prognosis of axonotmesis cases de-
membranes, whereas in the periphery, limb nerve pends on additional factors. In light of this, in
Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain
179 23
1951 Sunderland distinguished five degrees of le- classification of different fibrosis types [8]. It was
sion [20]. Today we consider his classification to conceived from a surgical point of view, as Millesi
be more detailed and more suitable than Seddon’s noted that the fibrosis could originate from quite
earlier one: different parts of the connective tissue within
Grade 1: This grade is identical to Seddon’s nerves. He classified fibrosis into types A–C, re-
neurapraxia, and it refers to myelin sheath de- garding the fact that only the epineurium, or the
generation restricted on a nerve segment due to a interfascicular connective tissue, or even the in-
slight trauma. trafascicular connective tissue (the endoneurium)
Grade 2: As a result of higher compressing could be involved in the fibrosis. This differentia-
forces, the axons undergo Wallerian degeneration, tion became important because, due to this fibro-
but each axon remains enclosed by its basal mem- sis, surgical limitations arise during microneuroly-
brane and endoneurium, and it is able, by axon sis. An epineural fibrosis can be easily released by
sprouting, to regain its former target. a longitudinal incision. In contrast, an endoneu-
Grade 3: Because of destructive forces on the ral fibrosis limits our surgical efforts completely.
endoneurium, the process of axon resprouting is Nerve segments with intrafascicular fibrosis have
partially hindered. On the other hand, mis-sprout- to be resected and reconstructed by grafting. Con-
ing leads to more extensive functional deficits: sequently, the surgeon’s task during each operation
Without endoneurium, motor axons may sprout is to estimate the type of fibrosis and decide which
into a sensory pathway, or vice versa, and thus microsurgical method is suitable [13].
achieve no function.
Grade 4: Because of disarranged perineurium,
the amount of mis-sprouting increases so exten- Microsurgical Options
sively that the recovery results after microneuroly-
sis are even more disappointing than with grades In general, we distinguish between neurolysis and
2 and 3 lesions. Especially in cases of small skin nerve reconstruction, with the latter consisting of
nerves as well as inguinal nerves, the intraneural either direct nerve suture or nerve grafting.
destructive effects are easily able to completely Both techniques today require a microscope
block the axon sprouts, a situation that results in to guarantee gentle handling of the nerve tis-
a neuroma in continuity. This kind of lesion is sue. With magnification, the epineurium in intact
comparable to a total nerve interruption, with no parts of the nerve proximal and distal to the
good prognosis as far as spontaneous recovery is injured area can be incised longitudinally. After
concerned. that, the external sheath of the epineurium can
Grade 5: This lesion is identical to Seddon’s be removed. As a next step, individual groups of
neurotmesis, a complete interruption of nerve fascicles are exposed and slightly separated from
trunk continuity. It is associated with a terminal each other. When approaching the injured nerve
neuroma at the proximal nerve stump 6–8 weeks segment, the surgeon should try to continue; if
after the nerve trauma. that is not possible, he or she has to switch over to
repair. But at first, at the separated fascicle groups,
the surgeon should try to incise the perineurium
Secondary Connective Tissue Reactions if scarred.
These microneurolysis steps are referred to as
Following a nerve injury, not only nerve destruc- epineurotomy, epineurectomy, and interfascicular
tion but also secondary connective tissue reac- neurolysis. These different surgical steps can be
tions start; histologically, these are well-known applied to limb nerves of sufficient caliber; how-
processes referred to as fibrosis. The ensuing scar ever, the smaller in diameter the nerve is and the
tissue develops compressing forces and blocks the more multifascicular, the greater the number of
axon-sprouting process. Considering all of these limitations that will arise, particularly in cases of
secondary effects, in 1992 Millesi established a skin nerves and inguinal nerves.
180 Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain, Classification, and Options in Surgical Therapy

Nerves with loss of continuity or untreatable tion area of the affected nerve; rather, it is diffuse,
intraneural fibrosis should be reconstructed if and it disappears after nerve decompression [13].
possible. The approach to nerve repair that must This type of nerve-trunk-related pain is not a mat-
be implemented for these lesions changed in the ter of discussion because a substantial intraneural
1960s [9]. The former nerve repair techniques in- nerve lesion usually does not arise in an entrap-
volved the epineural end-to-end suture, but histo- ment situation.
23 logical studies showed that fibrosis and neuromas Instead, we have to deal with nerves that (1) are
developed on the suture side [3]. The develop- small in diameter, (2) predominantly contain sen-
ment of microsurgical grafting resulted in two sory fibers, (3) easily react with intraneural severe
advantages: A more accurate approximation of fibrosis, and (4) additionally limit our microsurgi-
corresponding fascicles could be achieved [8, 16], cal efforts while often being unfavorably localized.
and restoration of nerve continuity without ten- In particular, these nerves tend to develop intrac-
sion significantly reduced the amount of fibrosis table pain, and we need to strictly avoid attach-
at the coaptation sites [10]. Despite the fact that ing the label »psychologically peculiar« to persons
the axons had to overcome two coaptation sites with resistant pain of those nerves.
after grafting, the end results 40 years ago were so We are thus confronted with three potential
encouraging that grafting became the method of levels of pain:
choice from then on [9]. In the meantime, all of 1. Neuroma pain, a normally nonexistent pain
the mentioned principles of microsurgery became that occurs when triggered by palpation at
well known. the location where sensory nerve fibers are
blocked from regrowing. Palpation thereby
causes an electric-current-like pain that the
Pain Associated with Nerve Lesions patient localizes in the distribution area of the
injured nerve.
In former decades, nerve surgeons were convinced 2. Hyperpathic pain, a normally nonexistent pain
that these microsurgical principles could success- of unbearable intensity if the skin in the distri-
fully be applied to pain related to nerve injury. bution area of the injured nerve is repeatedly
They believed that removal of the neuroma had stimulated
to be the solution in pain relief; resprouting of 3. Allodynia, a pain that is permanently present
sensory axons would sufficiently help nociceptive as a burning sensation and that is triggered by
afferents become stabilized by achieving their for- an innocuous stimulus
mer targets. But this concept did not reliably work.
In 1981, a study on this subject described the high Both of the last two types of pain are also referred
failure rate of nerve resection and grafting to cure to as neuropathic pain.
the associated chronic nerve-related pain [12]. All Neuroma pain appears about 6 weeks follow-
of the patients reported in this study underwent ing the nerve lesion because a neuroma needs
reconstruction of the injured and painful nerve this time to develop. Consequently, neuroma pain
segment by grafting of the sural nerve. Although starts slowly and achieves a steady state weeks
motor or sensory nerve function was successfully later. In contrast, neuropathic pain (1) has a sud-
restored in all seven patients, their pain returned den onset, (2) appears rather early after the nerve
in the precise state and location as experienced lesion, and (3) immediately achieves a steady
preoperatively. Today, mechanisms proximal to the state.
nerve lesion are recognized as responsible for the Therefore, it is very important to evaluate all
recurrence of nerve-related pain, and we are even the details of the patient’s anamnesis to estimate
aware of the risk of duplicating the pain [23]. his or her individual type of pain. It may be of ad-
Entrapment syndromes of limb nerves usually ditional importance to assess the patient because in
cause a more or less bearable pain. The pain does the case of allodynia, you should be able to apply a
not remain restricted to the autonomous distribu- quite light stimulus to a small skin area to provoke
Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain
181 23
a highly painful sensation that spreads away from Treatment Modalities for Painful
the actual stimulus location. This special attribute, Nerves
by the way, may be the reason that we sometimes
cannot exactly differentiate which one of the ingui- Microsurgery
nal nerves is really affected. Unfortunately, the dis-
tribution areas of the iliohypogastric, ilioinguinal, The above-mentioned microsurgical principles of
and genitofemoral nerves are located side by side, neurolysis and nerve repair are relevant only if
and variations also exist [17, 21]. neuroma pain is present. As far as possible, the
According to animal models and clinical stud- type of pain has to be estimated preoperatively.
ies, the following pathophysiological mechanisms Nevertheless, there is a risk of about 30% of induc-
presumably contribute to the occurrence of neu- ing an ensuing neuropathic pain. This holds true
ropathic pain: if nerves of trunk caliber are affected. But con-
▬ Continuous abnormal excitation of afferent sidering the particular difficulties with the small
fibers due to ongoing compressing forces [1] abdominal wall nerves encountered in hernia sur-
▬ Impaired intraneural microcirculation that gery, microsurgery on these nerves is more and
might induce ensuing ischemia and nerve more out of discussion.
damage [11] If a neuropathic pain is initially presented,
▬ An abnormal excitatory coupling between microsurgery even carries the danger of duplicat-
sympathetic fibers and afferent nociceptive ing the pain level in the patient. Thus, regarding
fibers, especially within the spinal ganglion [6] neuropathic pain, our experience today is that
▬ Hindered or interrupted axonal transport in touching a nerve at the damaged site almost always
both directions in the nerve fibers that may induces additional central nervous plasticity. This
result in loss of control of the biochemical ac- experience holds true independent of the nerve
tivity in the nerve cell body [4] caliber.
▬ Central alterations of electrophysiological
activities in an afferent neuron that may
spread transsynaptically to second-order and Neurotomy
higher-order neurons in the spinal cord and
brain [2] We understand neurotomy as nerve transection
proximal to the primary nerve lesion. Of course,
In conclusion, the effects of nerve injury and nerve recurrent neuroma formation will always start
damage are not confined to the site of the lesion, and stop about 6–8 weeks later. If the regrown
as previously expected. Instead, neuropathic pain neuroma at the proximal nerve end is imbedded
seems to be a result of an earlier unexpected within soft tissue, the risk of ongoing repeated
central nervous plasticity [23], and it is addition- triggering may be reduced. If, for example, we
ally influenced by individually different disposi- operate on Morton’s neuralgia, neurotomy via a
tions. We have no theoretical basis to explain why dorsal approach will be the only way to succeed
some patients, but not all, develop neuropathic [13]. But patients with Morton’s neuralgia never
pain. Thus, different individual dispositions seem present with a neuropathic pain syndrome. On
to be responsible for the fact that identical nerve the other hand, 27 of 29 laparoscopic »triple neu-
lesions cause varying reactions. Experiments in rotomies« of all three inguinal nerves have been
1980 on different types of rats revealed different quite successful (N. Kleemann, personal com-
measurable amounts of autotomy following identi- munication). Considering the experience with a
cal procedures on nerves. The authors concluded greater number of hyperpathic pain syndromes in
that different genetic dispositions must exist [5]. the inguinal area, these results seem to be in con-
The experience in hernia surgery presumably will trast to the above-mentioned thesis. The actual
be that only some patients will sustain real neuro- impression, therefore, is that neurotomy at least
pathic pain following surgery [21]. remains under discussion.
182 Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain, Classification, and Options in Surgical Therapy

Neuromodulation ▬ No additional sensory loss, particularly if int-


raabdominal »triple neurotomies« (neurotomy
The idea of achieving pain relief by electrically of all three inguinal nerves) are used
stimulating the dorsal columns of the spinal cord ▬ No risk of inducing a neuropathic pain or du-
(known as spinal cord stimulation or SCS) was plicating the preexisting pain level
derived from the gate control theory by Melzack
23 and Wall in 1965 [7]. According to this concept,
stimulation of large afferent A-fibers of periph- Conclusion
eral nerves should reduce the pain input to the
brain via the small unmyelinated and thinly my- The scientific considerations of different types of
elinated C-fibers. Because the conduction veloc- nerve lesions, secondary fibrosis, microsurgical
ity of A-fibers is faster than that of the C-fibers, procedures, and the regeneration process after mi-
A-fibers were said to have the capacity to »gate crosurgery were insufficient for solving the prob-
out« pain stimuli from transmission to the cortex lem of nerve-related pain until today. A differen-
[7]. Currently, this technique is not only applied tiation of whether the patient presents with either
on dorsal columns of the spinal cord but also neuroma pain or neuropathic pain is of great im-
on peripheral nerves [19]. If technically pos- portance. Microsurgical methods, with their risks,
sible, the epineurium of the nerve is pierced, and can be applied to neuroma pain, and neuromodu-
a quadripolar electrode is pushed slightly into lation, which carries less risk but is dependent on
the subepineural space a few centimeters distal technical details, can be used for neuropathic pain.
or proximal, depending on the affected nerve In cases of affected inguinal nerves, laparoscopic
and its availability [13]. After a test stimulation neuromodulation seems to be a reasonable techni-
period of a few days, the external screener is cal solution in the future, whereas neurotomy is
changed to an internal subcutaneously placed under discussion as a high-risk procedure as far as
pacemaker. pain relief is concerned.
In cases of painful involvement of very small
nerve branches that are not surgically accessible
for the above-mentioned direct nerve stimulation References
(dPNS), and in cases of excessive scarring, the
treatment can consist of subcutaneous peripheral 1. Bennett GJ, Xie Y-K (1988) A peripheral mononeuropathy
in rat that produces disorders of pain sensation like those
nerve stimulation (sPNS). Here, the electrode
seen in man. Pain 33:87–107
is percutaneously advanced to the location of 2. Devor M (1988) Central changes mediating neuropathic
the assumed nerve damage. The intraoperative pain. In: Dubner R, Gebhart GF, Bond MR (Eds) Proceed-
test stimulation should induce pleasing paresthe- ings of the 5th World Congress on Pain, vol 3. Elsevier,
sias in the distribution of the affected nerve. Amsterdam, pp 114–128
3. Edshage S (1964) Peripheral nerve suture. Acta Chir Scand
This method often achieves a good response to
(suppl) 331:1–104
painful conditions of injured inguinal nerves 4. Herdegen T, Fiallos-Estrada CE, Bravo R, Zimmermann M
and even has an effect on the frequently associ- (1993) Colocalisation and covariation of c-JUNtranscrip-
ated localized tenderness in the area of the scar tion factor with galanin in primary afferent neurons with
tissue [22]. CGRP in spinal motoneurons following transection of rat
sciatic nerve. Mol Brain Res 17:147–154
But the gold standard in the future may per- 5. Inbal R, Devor M, Tuchendler O, Lieblick (1980) Autotomy
haps be a laparoscopic approach. Possover and following nerve injury: genetic factors in the develop-
colleagues reported on their recent experiences ment of chronic pain. Pain 9:327-337
applying these techniques to the intrapelvic course 6. Jänig W (1991) Sympathetic activity during peripheral
nerve injury. In: Besson JM, Guilbaud G (eds) Lesions of
of the inguinal nerves by a laparoscopic approach
primary afferent fibers as a tool for the study of clinical
[14, 15]. The great advantages of intraabdominal pain. Elsevier, Amsterdam, pp 65–82
or pelvic neuromodulation compared with neuro- 7. Melzack R, Wall P (1965) Pain mechanisms: a new theory.
tomy are the following: Science 150:971–979
Chapter 23 · Surgical Trauma of Nerves–Causes of Neuropathic Pain
183 23
8. Millesi H (1992) Chirurgie der peripheren Nerven. Urban prevent neuroma formation. I reviewed the lit-
& Schwarzenberg, Munich erature and I have not found any data concerning
9. Millesi H, Meissl G, Berger A (1976) Further experiences
this question. What do you think is the better to
with interfascicular grafting of the median, ulnar, and
radial nerves. J Bone Joint Surg 58A:209–218 prevent pain, to ligate the cut ends of the nerve or
10. Millesi H, Meissl G (1981) Consequences of tension at to implant them in the muscle? What is your per-
the suture site. In: Gorio A (ed) Posttraumatic peripheral sonal recommendation?
nerve regeneration; experimental basis and clinical impli- Penkert: There are no conclusive data until now
cation. Raven Press, New York, pp 277–279
11. Myers RR, Yamamoto T, Yaksh TL, Powell HC (1989) The
what to do with a nerve when you have cut it.
role of focal ischemia and Wallerian degeneration in pe- However there are some reports which recom-
ripheral nerve injury producing hyperesthesia. Anesthesi- mend the implantation of a cut nerve in fatty tis-
ology 78:308–316 sue, others recommend the ligation of a cut nerve.
12. Noordenbos W, Wall PD (1981) Implications of the fail-
However, we do not have significant data what
ure of nerve resection and graft to cure chronic pain
produces by nerve lesion. J Neurol Neurosurg Psychiat to do with a nerve end after transsection. In my
44:1068–1073 opinion any additional harm to the nerve is not
13. Penkert G, Fansa H (2004) Peripheral nerve lesions. good. May be after the transsection of a nerve the
Springer, Berlin implantation in a muscle is the best way. But an-
14. Possover M, Baekelandt J, Chiantera V (2007) The laparo-
other important thing is that neuropathic pain oc-
scopic approach to control intractable pelvic neuralgia:
from laparoscopic pelvic neurosurgery to the LION tech- curs within a few days after the harm to the nerve,
nique. Clin J Pain 23(9):821–825 whereas chronic pain occurs within weeks after the
15. Possover M, Baekelandt J, Chiantera V (2007) The lap- damage of a nerve.
aroscopic implantation of neuroprothesis–LION tech- Schumpelick: The anesthesiologists told us that
nique–to control intractable abdomino-pelvic neuralgia.
Neuromodul 10:18–23
we should give local anesthesia to the nerve before
16. Samii M, Penkert G (1998) Traumatic disorders of the pe- we cut it, because there is a kind of pain memory.
ripheral nervous system. In: Cruz J (ed) Neurological and Can you comment on this? And what is the best
neurosurgical emergencies. Saunders, Philadelphia, pp method to dissect a nerve, better to do it with a
349–362
scissor or with a scalpel?
17. Schumpelik V, Kingsnorth G (1999) Incisional hernia of
the abdominal wall. Springer, Berlin Penkert: As a neurosurgeon we try to avoid a dis-
18. Seddon HJ (1943) Three types of nerve injury. Brain section a nerve. However if necessary you should
66:237–288 try minimize the harm to the nerve. May be local
19. Shetter AG, Racz GB, Lewis R, Heavner JE (1997) Periph- anesthesia can be beneficial, but only if there is no
eral nerve stimulation. In: North RB, Levy RM (eds) Neu-
rosurgical management of pain. Springer, New York, pp
additional harm to the nerve. And it doesn’t matter
261–270 whether you use a scissor or a scalpel. At least it is
20. Sunderland S (1951) A classification of peripheral nerve said, that there is a pain memory.
injuries producing loss of function. Brain 74:491–516 Miserez: You mentioned local neuromodulation.
21. Töns CH, Schumpelik V (1990) Das Ramus-genitalis-Syn-
What is about pharmacological neuromodula-
drom nach Hernienoperation. Chir 61:441–443
22. Winkelmüller M (2005) Which nerve is suitable for periph-
tion?
eral nerve stimulation? Presentation at the 15th Work- Penkert: Mostly those medicaments have notable
shop, Pain Section, German Society of Neurosurgery side effects. And the most young patients doesn’t
23. Zimmermann M (1994) Basic neurophysiological mecha- accept those side effects.
nisms of pain and pain control. In: Horsch S, Claeys L (eds)
Jacob: Are locally applied steroids justified in case
Spinal cord stimulation. Springer, Berlin, pp 3–18
of neuropathic pain?
Penkert: The first step should be the field stimu-
lation in the area of the neuropathic pain. If it
Discussion doesn’t work the second step could be the laparo-
scopic approach. These are the only things that
Amid: We do a lot of triple-neurectomies in pa- you can do in case of neuropathic pain following
tients with chronic pain. Our neurosurgeons told surgery. However it is different in case of chronic
us that we should ligate the cut ends in order to pain.
24

Risks for Pain–Neuropathic Pain:


How Should We Handle the Nerves?
D. Kaemmer, R. Rosch, M. Stumpf, J. Otto, K. Junge, U. Klinge V. Schumpelick
186 Chapter 24 · Risks for Pain–Neuropathic Pain: How Should We Handle the Nerves?

Introduction was 6 months. Iliohypogastric, ilioinguinal, and


genitofemoral nerves were explanted bilaterally via
In hernia surgery, interest has been focused more a retroperitoneal approach. Nerves were stored
and more on pain, a problem that remained un- in paraformaldehyde 4% and were processed for
derestimated because only relatively few patients histology, cross-polarisation microscopy, and im-
seemed to be affected. Chronic pain evolves in munohistochemistry. Antibodies against MMP-2
a high percentage after surgery with the need to (1:1000, Biomol, Hamburg, Germany), CD64
mobilize or even compress nerves [1]; however, (Helmholtz Institute for Applied Medical Engi-
24 after groin hernia repair, symptoms vary to a high neering, Aachen, Germany), and COX-2 (DCS In-
degree [2]. Pain character is mostly neuropathic, novative Diagnostic-Systeme, Hamburg, Germany)
but due to overlapping distribution areas it is not were applied for immunohistochemical analyses.
clearly related to certain nerves [3]. The neuro- Collagen I/III ratios were analysed as described
pathic pain character is accompanied by an inflam- previously [5]. Mast cells were detected by Giemsa
matory pain for some time after operation, which staining. Histological findings were evaluated us-
is understandable, especially when a mesh was ing a semiquantitative score ranging from 0 to 4
used and foreign material remains in the body. (0: 0% positive cells; 1: 5% positive cells, 2: 5–30%
Nerve damage during and chronic pain after positive cells; 3: 30–80% positive cells, 4: >80%
hernia repair have been poorly evaluated in the positive cells), and scores of nerves were pooled.
past, but clinical studies illuminate clinical conse- In a second series we evaluated pigs (n=3, con-
quences and symptoms [4]. Nevertheless, little ex- trol n=1) receiving a neurotomy with cauterisation
perimental data exist to give clear advice on how of the iliohypogastric, ilioinguinal, and genitofemo-
to handle healthy or damaged nerves in the groin. ral nerves on one side and neurotomy without cau-
In groin hernia repair, it is necessary to mobilise terisation contralaterally. The operating procedure
the groin nerves traversing the operating field and included bilateral exploration of the groin region,
retract them during the procedure. Furthermore, opening of the inguinal canal, and identification
in recurrent groin hernia repair it is sometimes of the nerves. After neurotomy with or without
necessary to resect nerves incorporated in scar cauterisation, the inguinal canal was closed without
tissue. using a hernia repair technique. A nerve specimen
We therefore conducted two pilot studies to from an untouched nerve served as control. The
evaluate how to handle nerves during groin hernia follow-up was 8 weeks. Iliohypogastric, ilioingui-
repair and to advocate for further research. Intra- nal, and genitofemoral nerves were explanted bilat-
neural fibrosis as a mechanism for nerve dysfunc- erally via a retroperitoneal approach. Nerves were
tion was of obvious interest, as well as the presence stored in paraformaldehyde 4% and were processed
of inflammatory cells revealed by Giemsa staining for histology, cross-polarisation microscopy, and
and markers for inflammation such as COX-2, immunohistochemistry as described above.
MMP-2, and CD64 as a marker for activated mac-
rophages.
Results

Materials and Methods Six months after bilateral Lichtenstein repair, ex-
pression of MMP-2, COX-2, and CD64 was in-
In uncastrated male pigs (n=6, control n=1), bi- creased compared with controls. Collagen I/III
lateral Lichtenstein repair was performed using a ratios were also slightly elevated, implying that a
common technique. Each animal received repair higher relative amount of collagen I was present.
with a small-pore polypropylene mesh (mesh M) No mast cells were detected in either group (Gi-
on one side and a large-pore polyvinylidene mesh emsa staining). Altogether, there were no differ-
(mesh P) contralaterally. A nerve specimen from an ences between the large-pore and the small-pore
untouched nerve served as control. The follow-up meshes (⊡ Fig. 24.1).
Chapter 24 · Risks for Pain–Neuropathic Pain: How Should We Handle the Nerves?
187 24
10
9
8
7
6
score/ratio

5
4
3
2
1 ⊡ Fig. 24.1. Results of first series
6 months after bilateral Lichtenstein
0
MMP-2 COX-2 CD 64 Collagen I/III repair (Mesh M small-pore polypro-
pylene mesh; Mesh P large-pore poly-
Mesh M Mesh P vinylidene mesh)

10
9
8
7
6
score/ratio

5
4
3
2
1
0
MMP-2 COX-2 CD 64 Collagen I/III ⊡ Fig. 24.2. Results of second
series 8 weeks after bilateral groin
cauter scissor exploration

Eight weeks after bilateral groin exploration, Discussion


higher numbers of MMP-2, COX-2, and CD64-
positive cells were observed compared with con- Patients suffering pain after groin hernia repair have
trol nerves. Expression of MMP-2 was higher than been an underestimated collective in clinical research
6 months after Lichtenstein repair. Again, the col- so far. This is mirrored by the confusion about how
lagen I/III ratio was increased, and no mast cells to handle intact or damaged nerves during surgery.
were found. It is known that cutaneous afferent neurons
This effect at 8 weeks after groin exploration react more sensibly to damage [6]. Although ex-
was independent of the method by which neuro- perimental knowledge exists that little damage is
tomy was performed. The elevations were similar for caused by simply mobilising nerves [7], stretching
neurotomy with cauterisation and neurotomy alone [8] or compressing [9] them leads to detectable and
(⊡ Fig. 24.2). Neither inflammatory markers nor col- sustaining dysfunction. There has been discussion
lagen ratios changed in these two groups, but they about the amount of distension that is tolerable [8];
were clearly elevated compared with control values. nevertheless, almost always during hernia repair,
188 Chapter 24 · Risks for Pain–Neuropathic Pain: How Should We Handle the Nerves?

nerves are at risk for damage because the upper surgical method. If a neuroma is already present,
stretching limit is ~15% of nerve length. It has been or if resection is necessary for other reasons, the
shown that even without clear detectable nerve existing literature seems to favour burying the
damage, pain and measurable dysfunction of the proximal nerve end into muscle, with or without
nerves can persist independent of the use of a mesh ligation or capping [11, 12]. A general standard
prosthesis [10]. This supports our finding that procedure is difficult to suggest because of small
no differences exist between different transection trial sizes. In the case of inguinal nerves, further
methods or between different large-pore meshes. research is needed to establish rational treatment.
24 Even after hernia repair, nerves are at risk
because compression, such as that caused by he-
matoma or seroma, can compromise intraneural Acknowledgments
blood flow. Experimental analyses in the rabbit
sciatic nerve revealed a complete interruption We are grateful to Mrs. Ellen Krott for her excellent
of intraneural blood flow at pressures of about and careful assistance during this investigation.
50–70 mmHg [9]. Whether these pressures are
evoked by seroma or hematoma formation, for
instance, remains to be elucidated, but possible References
nerve damage should be taken into account when
deciding whether and to what extent seromas or 1. H. Kehlet, T.S. Jensen, C.J. Woolf, Persistent postsurgical pain:
risk factors and prevention. Lancet 367 (2006) 1618–1625
hematomas should be treated. It should also be
2. A.S. Poobalan, J. Bruce, W.C. Smith, et al., A review of chro-
mentioned that a small impairment of nerve integ- nic pain after inguinal herniorrhaphy. Clin J Pain 19 (2003)
rity and function could possibly be aggravated by 48–54
continuous or rising pressure. 3. T. Mikkelsen, M.U. Werner, B. Lassen, H. Kehlet, Pain and
sensory dysfunction 6 to 12 months after inguinal hernio-
tomy. Anesth Analg 99 (2004) 146–151
4. E.K. Aasvang, B. Brandsborg, B. Christensen, et al., Neuro-
Conclusion
physiological characterization of postherniotomy pain.
Pain 137 (2008) 173–181
During hernia repair, nerves should be identified 5. R. Rosch, K. Junge, M. Knops, et al., Analysis of collagen-
and carefully mobilised if necessary to protect interacting proteins in patients with incisional hernias.
Langenbecks Arch Surg 387 (2003) 427–432
nerves traversing the operating field from damage.
6. P. Hu, E.M. McLachlan, Selective reactions of cutaneous
Stretching of nerves by hooks should be minimised and muscle afferent neurons to peripheral nerve transec-
whenever possible. Compression of nerves after tion in rats. J Neurosci 23 (2003) 10559–10567
hernia repair by hematoma or seroma as a possible 7. D.G. Kline, E.R. Hackett, G.D. Davis, M.B. Myers, Effect of
source of (further) damage should be avoided. mobilization on the blood supply and regeneration of
injured nerves. J Surg Res 12 (1972) 254–266
Although 6 months after Lichtenstein repair
8. J. Haftek, Stretch injury of peripheral nerve. Acute effects
no clear difference existed between large-pore and of stretching on rabbit nerve. J Bone Joint Surg Br 52
small-pore meshes in our model, the impact of al- (1970) 354–365
loplastic prostheses on chronic pain remains to be 9. K. Ogata, M. Naito, Blood flow of peripheral nerve effects
elucidated. This pilot study constitutes a very small of dissection, stretching and compression. J Hand Surg
[Br] 11 (1986) 10–14
sample and lacked a control group using Shouldice
10. F. Karakayali, M. Karatas, U. Ozcelik, et al., Influence of
repair. synthetic mesh on ilioinguinal nerve motor conduction
Regarding the need for nerve resection during and chronic groin pain after inguinal herniorrhaphy: a
surgery, we observed no difference between neu- prospective randomized clinical study. Int Surg 92 (2007)
rotomy with and neurotomy without cauterisation 344–350
11. J. Lewin-Kowalik, W. Marcol, K. Kotulska, et al., Prevention
in our model.
and management of painful neuroma. Neurol Med Chir
To prevent neuroma formation with the pos- (Tokyo) 46 (2006) 62–67
sibility of neuropathic pain, the proximal nerve 12. J. Wu, D.T. Chiu, Painful neuromas: a review of treatment
stump must be provided with the most appropriate modalities. Ann Plast Surg 43 (1999) 661–667
Chapter 24 · Risks for Pain–Neuropathic Pain: How Should We Handle the Nerves?
189 24
Discussion

Gryska: How do you exactly handle the nerve in


case of implanting it in a muscle?
Rosch: We just have done a simple dissection of
the nerves. However there are studies showing that
there might be a benefit for the patients if you im-
plant the nerve end in a muscel. And additionally
we didn´t see any differences if we have ligated or
coagulated the nerve in the retroperitoneal space.
However there might be changes in the dorsal
route ganglion.
Peiper: In Lichtenstein hernia repair the ilioin-
guinal nerve runs through the operation field and
following mesh implantation you achieve a distant
contact between the mesh and the nerve. Is there
any place in routine to dissect the nerve in this
situation?
Rosch: If you look to the studies there is no dif-
ference between the patient following Lichtenstein
repair and Shouldice concerning the postoperative
chronic pain. Therefore actually we would recom-
mend any trauma to the nerves in order to avoid
damage to the nerve.
Amid: In some cases an adequate repair of an
inguinal hernia is not possible without dissection
of the ilioinguinal nerve. In those cases we dissect
the nerve. But now it appears that it is important to
implant the nerve in the muscle.
25

What To Consider as Clinicians


About Chronic Postoperative Pain
and Inguinal Herniorrhaphy
D. Hegarty
192 Chapter 25 · What To Consider as Clinicians About Chronic Postoperative Pain and Inguinal Herniorrhaphy

Introduction impact of the work and social environments, as


well as the impact of any tissue abnormality, pain,
Inguinal hernias account for 75% of all abdominal and relevant biomedical factors on progression
wall hernias, with a lifetime risk of 27% in men and through the problem and eventual outcome. For
3% in women [1, 2]. The rate of repair of inguinal example, psychosocial factors are now acknowl-
hernia ranges from 10 per 100,000 of the popula- edged to predict low back pain outcome far better
tion in the United Kingdom to 28 per 100,000 in the than do the available physical and biomedical find-
United States [3]. Of these patients, chronic post- ings [16]. While the bulk of the recent research is
operative inguinal pain occurs in up to 54%. The still in the area of low back pain, it is reasonable to
persistence of postoperative inguinal herniorrhaphy expect that psychosocial factors also significantly
pain for longer than 3 months following surgery has impact other benign musculoskeletal pain states
25 gained interest during the last years, becoming the and disabilities such as inguinal herniotomy [17].
most important outcome variable besides recur- In order to propose a clinically relevant assess-
rence rates [4–6] because this pain affects and im- ment and management model that integrates new
pairs activities of daily life in 12% of patients [7–10]. concepts, compartmentalisation of the important
Indeed, pain-related sexual dysfunction, including clinical features is required. Fundamental to this
dysejaculation, is now recognised to occur in at least compartmentalisation strategy is the gathering of
2% of young men [11]. Therefore, before surgery is patient-relevant material that can be managed,
considered for a benign disease, complications such adapted, accepted, improved, and resolved using
as severe chronic pain, with its debilitating effects, a balanced combination of patient and clinical
must be carefully weighed against the benefits [12]. input [18].
Many studies have examined the surgical fac- Six interrelating compartments need to be as-
tors that contribute to development of postoperative sessed, with the potential for management in a
herniorrhaphy pain. For example, the intraoperative parallel fashion. In this way, treatment of a patient
factors shown to be associated with the lower inci- with chronic herniotomy pain might include the
dence of nondisabling, mild, and moderate chronic following:
pain include the use of lightweight meshes and the 1. Adequate explanation of the problem, which
laparoscopic approach [13]. The traditional assump- is dominated by giving reassuring information
tion that chronic pain after herniorrhaphy pain is (e.g. causes, likely course, and normal pain
neuropathic in origin, and is secondary to direct behaviour)
surgical trauma or postoperative inflammation of 2. An explanation of the treatment and manage-
the nerves, has therefore been challenged [14]. ment strategy as well as the likely outcome,
As clinicians we need to consider the role using the best available evidence
of patient-related factors in the development of 3. A graded exercise programme to improve
chronic postherniorrhaphy pain, not just the sur- muscle weakness and general fitness
gery-related factors. This overview seeks to exam- 4. A combination of rest and activity using prin-
ine these patient factors and to propose an assess- ciples of pacing and incrementation [19, 20]
ment and management model that integrates new 5. Encouragement of relaxation, ergonomics, and
ideas while at the same time maintaining contact the appropriate use of transcutaneous electri-
with current therapies and approaches but placing cal nerve stimulation and analgesics for pain
them in a more open and appropriate context. management
6. Help with preparations for a graded return to
work [21]
The Biopsychosocial Model
The precise integration of these compartments is
The biopsychosocial model proposed by Waddell not a recipe to be prescribed; rather, it is guided
et al. [15] draws attention to the interaction of the by the patient’s individual presentation, capacities,
patient’s response to his or her situation and the and negotiated goals. This article suggests that each
Chapter 25 · What To Consider as Clinicians About Chronic Postoperative Pain
193 25
case of chronic inguinal herniorrhaphy pain can be Neurological origin
considered using the following six compartments:  Postsurgical neuroma: painful scar
1. Biomedical factors  Neuralgias (i.e. iliohypogastric, ilioinguinal, genito-
2. »Flagging« of psychosocial barriers to recovery femoral)
 Postherpetic neuralgia
3. Reactivation and rehabilitation
 Peripheral neuropathy
4. Identification of physical impairments  Central pain: post stroke or post spinal cord injury
5. Encouragement of physical fitness  Neuralgias (i.e. iliohypogastric, ilioinguinal, genito-
6. Treatment of pain femoral)
 Herniated nucleus pulposus
 Guillain-Barré syndrome
 Neurofibromatosis
Compartment 1: Biomedical Factors
Musculoskeletal origin
 Thoracic, lumbar, or sacral spinal disease
When pain arises from particularly private sites or
 Pelvic floor or abdominal muscular spasm
those associated with basic bodily functions, such  Coccygodynia
as urination or ejaculation, the condition becomes  Fibromyalgia
complicated by psychological as well as unique
Urological
physiological issues. These structures have inner-  Interstitial cystitis
vation that converges within the central nervous  Polycystic kidney
system, making symptoms alone inadequate as di-  Loin pain haematuria
agnostic tools. Even a precise history and meticu-  Stag horn calculus
 Urethral syndrome
lous physical examination may result in diagnostic
 Urethral diverticulum or caruncle
ambiguity. For example, directly asking patients to  Detrusor dyssynergia
localise the epicentre of their inguinal pain on ana-
Male reproductive
tomical charts does not appear to be helpful [14].
 Orchialgia
Patients may contribute further to the ambiguity  Prostatodynia, chronic prostatitis, or chronic pelvic
by omitting observations they find to be too embar- pain syndrome
rassing to describe or discuss (e.g. dysejaculation  Penile pain
[11]). Nevertheless, clinicians have a responsibility Female reproductive (gynaecological) pain
to ensure that another underlying diagnosis is not Cyclical
being overlooked. Consideration should be given to  Mittelschmerz, other ovarian pain
the possibility of a secondary neurological, gastro-  Primary dysmenorrhoea
 Secondary dysmenorrhoea (uterine abnormalities,
intestinal, musculoskeletal, or urological diagnosis
cervical stenosis, uterine leiomyoma, adenomyosis,
to explain the chronic symptoms. ⊡ Table 25.1 high- imperforate hymen)
lights some common differential diagnoses that may
Noncyclical or atypical cyclical
need to be considered in each individual case [22].  Adhesions
 Endometriosis
 Pelvic relaxation, prolapse, retroversion of the uterus
⊡ Table 25.1. Possible differential diagnoses of  Vulvodynia
chronic pain localised to inguinal area structures  Ovarian remnant syndrome
 Dyspareunia without vulvodynia
Gastrointestinal origin  Pelvic congestion syndrome
 Hernia: recurrent bowel obstruction  Adenomyosis
 Colitis: radiation enterocolitis, Crohn’s disease, ulce-  Chronic pelvic pain without obvious pathology
rative colitis
 Diverticular disease of the colon Other pain states
 Irritable bowel syndrome  Chronic pelvic organ ischaemia
 Chronic constipation: faecal impaction  Acute intermittent porphyria
 Proctalgia fugax  Familial Mediterranean fever
 Infectious diarrhoea  Systemic lupus erythematosus
▼  Psychogenic pain
194 Chapter 25 · What To Consider as Clinicians About Chronic Postoperative Pain and Inguinal Herniorrhaphy

Assessment Tool Compartment 2: »Flagging« of


Until recently there was no standardised and vali- Psychosocial Barriers to Recovery
dated instrument to assess the severity of postop-
erative pain following inguinal hernia repair. The Clinicians should be encouraged to actively screen
Inguinal Pain Questionnaire (IPQ) has evolved for, identify, and then appropriately manage rele-
over the past number of years. It is a self-admin- vant psychosocial components to identify patients
istrated questionnaire that assesses the intensity of at risk of developing chronic pain and associated
the pain, its frequency, and the extent to which the disability problems from an early stage, perhaps
pain interferes with daily activity [6, 22]. Evidence even as early as the preoperative assessment [31].
now supports the use of the IPQ as an instrument This is not an attempt to label a patient’s chronic
in clinical studies as well as in the clinical routine postoperative inguinal hernia pain as psychologi-
25 to assess long-term pain following inguinal hernia cally mediated, but rather an attempt to identify
surgery [22]. some of the barriers to recovery that might be
present.
Contribution of Genetic Factors The »flagging initiative« used in the manage-
The large interindividual variability in the ex- ment of low back pain could be usefully transferred
perience of pain suggests that genetic variability to the area of chronic herniotomy pain. The pur-
may play an important role in chronic pain. Ge- pose of developing flags for chronic herniotomy
netic variants modulating pain continue to be would be to do the following [31, 32]:
discovered, and researchers expect that genetic ▬ Provide a method of screening for psychoso-
information may be exploited to treat pain or cial factors
to predict those who are at a greater risk of de- ▬ Provide a systematic approach for assessing
veloping pain. At present no clinical research is psychosocial factors
specifically examining the genetic variants that ▬ Suggest strategies for better pain management
may contribute to postoperative herniorrhaphy for those who appear to be at high risk for
pain. Therefore, we must rely on data from gen- chronicity
eral pain-related genetic research to assess the
relationship between genotype and phenotype. The aim of this flagging initiative should be to iden-
For example, functional genetic polymorphisms tify a number of key psychological factors [32]:
of catecholamine-O-methyltransferase (COMT) ▬ Presence of a belief that the pain is harmful or
are associated with altered sensitivity to pain in- severely disabling
duced in an experimental environment [23, 24]. ▬ Fear-avoidance behaviour patterns with re-
High COMT activity correlates with a risk of de- duced activity levels
veloping chronic temporomandibular joint pain ▬ Tendency to low mood and withdrawal from
[25]. Results of studies in rodents indicate that social interaction
the susceptibility to develop neuropathic pain ▬ Expectation that passive treatments rather
has a strong heritable component, but the genes than active participation will help
responsible have yet to be identified [26–28]. The
GTP cyclohydrolase gene has been proposed to In the management of acute and chronic pain
affect pain sensitivity and pain-related outcome states, enquiries about psychosocial factors and
following spinal surgery, although this process is their management are highly relevant and need
not completely clear [29, 30]. to be addressed. The results of early preventive
Given the complexity of neuropathic pain, it is programmes are persuasive and support the de-
likely that many genes contribute to the develop- velopment of prevention programmes in primary
ment of chronic pain. Studies are underway to cor- care for first-time sufferers; such programmes have
relate single nucleotide polymorphisms in multiple been shown to significantly–by eightfold–reduce
candidate genes with the risk of developing postin- disability and the risk of becoming chronic, as
jury neuropathic pain [30]. compared to »treatment as usual« [33]. The pro-
Chapter 25 · What To Consider as Clinicians About Chronic Postoperative Pain
195 25
gramme includes a thorough examination by a Compartment 4: Identification
doctor and a physical therapist; information de- of Physical Impairments
signed to reduce fear, uncertainty, and anxiety;
self-care recommendations; and the recommen- Physiotherapists are experts at observation, exami-
dation to remain active and continue everyday nation, and correction of physical abnormalities,
routines [33]. such as impairments found in tissue and joint
anatomy, biomechanics, tension, range, mobility,
strength, movement patterns, and functional ac-
Compartment 3: tivities. Physiotherapists draw on many impair-
Reactivation and Rehabilitation ment-focused skills, techniques, and approaches
that may coincidentally or intentionally also help
Reactivation and rehabilitation are strongly linked relieve pain and improve function [34]. Focused
to patient beliefs and behaviour, especially those physiotherapy is important and can assist in en-
relating to fear and avoidance (see the section on suring the best possible outcome for the patient
Compartment 2). Patients are often wary of mov- suffering chronic postoperative inguinal hernior-
ing or exercising because they lack confidence and rhaphy pain [34].
have not been given any clear advice or guidance.
In situations where they feel safe and supported,
patients can find that they are able to start moving Compartment 5:
normally and without any particularly bad reper- Encouragement of Physical Fitness
cussions [34].
A process using the principles of graded ex- Physical activity is perhaps the most powerful
posure is suggested [35, 36]. Negotiating adequate component in pain management programmes. In-
and appropriate functional goals with patients is creasing fitness is important not only in reversing
an important requirement [37]. By commencing the disuse syndrome but also in giving a power-
with activities and activity goals in an adequate ful signal to patients that they are beginning to
rest–activity ratio, the patient’s confidence will regain control over their musculoskeletal system.
improve, and further activity can be built on It is, therefore, extremely important from both the
from there. For example, being occupied diverts physical and the psychological points of view [37].
attention away from pain, whereas being inactive The detrimental effects of inactivity, immo-
leads to deconditioning and is also associated bilisation, disuse, deconditioning, and low physical
with withdrawal from work and social activities. fitness, and the beneficial general health effects re-
The consequences of this can result in feelings lated to increased activity and fitness are now well
of hopelessness and helplessness that can lead to established and extensively reviewed elsewhere. It
the onset of depression. In addition, improved seems essential for clinicians, whether involved
circulation, exchange of metabolites, and healing in the management of acute or chronic pain, to
are promoted by movement. Injured tissues tend quickly involve the patient in the maintenance or
to heal to the strength required by the demands improvement of his or her general physical health.
put on them [38]. Thankfully, a great many of the detrimental effects
The case for (1) the maintenance of function, are, with effort, reversible.
activity, or work in the acute management, (2)
the early return of function and activity in acute
and subacute management, and (3) the reestablish- Compartment 6: Treatment of Pain
ment of normal function in chronic pain-disabled
patients is now strong. Patients frequently need Clearly, a major goal of management is to reacti-
help with pain control and pain management (see vate patients. Pain management and pain control
section on Compartment 6: Treatment of Pain), so are important and are often a central feature of
this should be ensured as soon as possible. good therapy, ensuring the best possible outcome
196 Chapter 25 · What To Consider as Clinicians About Chronic Postoperative Pain and Inguinal Herniorrhaphy

for the patient. Targeting the pain source is not al- to that used for chronic low back pain patients, be
ways essential, but understanding the antecedents considered in inguinal hernia assessment. In the
for increases and decreases in the pain can often future, it is hoped that candidate pain genes can
yield better treatment and management strategies. be identified and exploited to predict those who
Readers are referred elsewhere for details on anal- are at greater risk of developing pain and to benefit
gesic options, but basic analgesic management in chronic postoperative inguinal pain management.
combination with advanced interventional strate-
gies should be considered as appropriate on an
individual patient basis. Clearly, a focused and References
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plied in a uniformed fashioned way in the mo-
Genet 14:135–143
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26

Risk Factors for Chronic Pain After


Groin Hernia Surgery
P. Nordin
200 Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery

Introduction for costs and quality of life, and because no treat-


ment has been shown to be effective, a detailed
Assessment of the outcomes of groin hernia surgery analysis of potential risk factors and the influence
has mainly focused on recurrence. However, with of surgical techniques is important.
modern surgical techniques and the introduction This chapter contains a review of risk fac-
of mesh, the recurrence rate has decreased consid- tors for chronic pain following herniorrhaphy. The
erably [1]. More recently there has been increased analysis is based partly on a detailed register-based
attention on other outcomes such as chronic pain, questionnaire study from the Swedish Hernia Reg-
convalescence, and patient satisfaction [2–8]. ister and partly on the European Guidelines for the
It is now well established from many multi- Treatment of Inguinal Hernia [11, 12].
centre/multinational studies that chronic pain af-
ter inguinal herniorrhaphy represents the most
important and disturbing sequela; it may not only Material and Methods
26 cause discomfort but also limit the individual’s
activities of daily living and have a considerable European Guidelines for the Treatment
impact on the person’s quality of life [7, 9]. of Inguinal Hernia
Occurrence rates vary extensively in the litera-
ture, which can be explained by the lack of a uni- The guidelines are exclusively evidence-based on
form definition of such pain and of a standardised results from scientific research and are divided
instrument for its assessment. Also, grading of into different levels of evidence. The levels vary
pain severity and the social consequences has of- from the highest level of evidence (1A), which is
ten been limited in studies addressing the risk based on results that have been consistently dem-
of long-term pain, and it is often categorised as onstrated in systematic reviews, to the lowest level
a dichotomous (yes/no) variable in the literature (4), which is based only on the opinion of experts
[10]. The reported prevalence rates of residual (see ⊡ Tables 26.1 and 26.2). This grading of scien-
pain range between 0% and 53%, but pain impair- tific evidence results in different levels of conclu-
ing daily activities following groin hernia repair is sions and grades of recommendations [12].
reported at a level around 10% [7, 9]. As part of the European Hernia Society
Because the development of chronic pain after Guidelines for the Treatment of Inguinal Hernia,
groin hernia repair may have major implications a review of published findings on risk factors for

⊡ Table 26.1. Levels of evidence (RCT randomised ⊡ Table 26.2. Grades of recommendation
controlled trial)
A Supported by systematic review and/or at
1A Systematic review of RCTs with consistent re- least two randomised controlled trials of
sults from individual (homogenous) studies good quality

1B RCTs of good quality Level of evidence: 1A, 1B

2A Systematic review of cohort or case-control B Supported by good cohort studies and/or


studies with consistent results from individual case-control studies
(homogenous) studies Level of evidence: 2A, 2B
2B RCT of poorer quality or cohort or case- C Supported by case series, cohort studies of
control studies low quality, and/or »outcomes« research
2C Outcome studies, descriptive studies Level of evidence: 2C, 3

3 Cohort or case-control studies of low quality D Expert opinion, consensus committee

4 Expert opinion, generally accepted treatments Level of evidence: 4


Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery
201 26
chronic pain after groin hernia surgery was car- with pain behaviour. The questionnaire consists of
ried out. Studies of chronic pain after inguinal 18 items, with pain in the contralateral (not oper-
hernia repair were identified using the PubMed, ated) groin used as a reference.
Cochrane Library, and Ovid search engines. Any
study–randomised, controlled trial, cohort, ques-
tionnaire, or follow-up–of adult (>18 years) pa- Results
tients with a primary or recurrent inguinal hernia
(asymptomatic or symptomatic; acute or elective) Results from the SHR-Based
was included. The search was conducted using Questionnaire Study
the term pain combined with inguinal hernia,
clinical trial, randomised controlled trial, chronic In the Swedish questionnaire study, 2,456 patients
pain, hernia repair, and neuropathy. Chronic pain (86%), of whom 2,299 were men and 157 were
is defined by the International Association for women, responded after two reminders. In re-
the Study of Pain as pain lasting for 3 months or sponse to a question about the »worst perceived
more [13]. pain last week,« 758 patients (31%) reported pain
to some extent. In 144 cases (6%), the pain inter-
fered with daily activities.
Swedish Hernia Register An age below the median, a high level of
pain before the operation, and occurrence of any
The Swedish Hernia Register (SHR) has compiled postoperative complications were found to sig-
detailed information on more than 160,000 groin nificantly and independently predict long-term
hernia repairs since its inception in 1992. Every pain in multivariate logistic analysis when »worst
inguinal or femoral hernia operation in patients pain last week« was used as the outcome variable.
age 15 or older performed at participating depart- The same variables, along with a repair technique
ments is recorded prospectively according to a using an anterior approach, were found to predict
standardised protocol. Annual checks by external long-term pain with »pain right now« as the out-
reviewers have found a validity of data of about come variable.
98% [4]. For a complete description of the SHR’s
recorded data, validity checks, etc., the reader is
referred to earlier publications [1, 14]. Swedish Hernia Register
From the population-based SHR, 3,000 pa-
tients age 15–85 years from 59 hospitals were sam- The SHR so far has no mandatory follow-up, but
pled from the 9,280 patients registered as having any reoperation because of chronic pain must be
undergone a primary groin hernia operation in the recorded. ⊡ Figure 26.1 presents reoperation rates
year 2000. Of these, the 2,853 patients still alive in because of chronic pain within 3 years for the dif-
2003 were requested to fill out a postal question- ferent methods of groin hernia surgery used in
naire to investigate the occurrence of residual pain Sweden. Plug techniques and open sutured repairs
intensity. have the highest risk, and totally extraperitoneal
(TEP), Lichtenstein, and Shouldice repairs have
the lowest risk of reoperation for chronic pain.
Inguinal Pain Questionnaire

The Inguinal Pain Questionnaire (IPQ) is a self- Results from the European Guidelines
recording instrument for chronic pain. It has been
validated and was shown to have high reliability The guidelines search covered all relevant litera-
and validity for assessment of long-term groin ture until April 2007 and literature of all level-1A
pain [15]. Pain intensity is rated on a seven-step and/or level-1B studies until May 2008. The results
fixed-point scale with steps operationally linked were divided into different levels of evidence.
202 Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery

0.61%
0.5%

0.46%

0.4% 0.41%

0.3%

0.25%

0.2%
0.19%
0.17%

0.1%
0.10%
26
0.0%
Lichten- Shouldice Open Open Open Plug TAPP TEP
stein nonmesh mesh preperitoneal

⊡ Fig. 26.1. Reoperation rates within 3 years because of chronic pain; n=142 (TAPP transabdominal preperitoneal repair;
TEP totally extraperitoneal repair)

⊡ Table 26.3. Results of multivariate logistic analysis of risk factors predicting any level of pain versus no pain regarding
the perception of »pain right now« (OR odds ratio; CI confidence interval)

Factor Patients perceiving pain, Univariate model Multivariate model


n (%) OR 95% CI OR 95% CI

Age
Median ≤59 years 345/1,026 (34%) 1 Reference 1 Reference
Median >59 years 205/976 (21%) 0.55 0.45–0.68 0.54 0.44–0.66

Gender
Male 517/1,878 (28%) 1 Reference
Female 33/124 (27%) 1.11 0.71–1.73

Preoperative pain level


Low 176/966 (18%) 1 Reference 1 Reference
High 374/1,036 (36%) 2.49 2.02–3.08 2.43 1.97–2.99

Postoperative complications
No 498/1,865 (27%) 1 Reference 1 Reference
Yes 52/137 (38%) 1.76 1.21–2.57 1.77 1.22–2.57

Hernia repair
Anterior approach 532/1,907 (28%) 1 Reference 1 Reference
Posterior approach 18/95 (19%) 0.58 0.34–0.99 0.56 0.33–0.95

Hernia anatomy
Femoral 5/34 (15%) 1 Reference
Medial 171/602 (28%) 2.90 1.02–8.25
Lateral 340/1,228 (28%) 2.44 0.87–6.83
Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery
203 26
Gender Nonmesh Repair
Level 2B: Females were found to have a higher Level 1B: Most studies comparing mesh with non-
risk of developing postoperative chronic pain than mesh repair report less chronic pain with mesh
males did [9]. repair [7, 9, 20].

Age Standard Polypropylene Mesh


Level 2A: In a randomised controlled trial (RCT) Level 1B: In three RCTs comparing lightweight
with 319 patients comparing three open mesh mesh with standard polypropylene mesh, two indi-
techniques, chronic pain was found to be related to cated that the use of lightweight mesh was associ-
younger age, and two population-based question- ated with significantly less pain on exercise after
naire studies found that younger age significantly 6 months [24] and less pain of any severity at 12
increased the risk [11, 16, 17]. months in the lightweight group [25]. In the third
study [26], there was no difference in neuralgic
Preoperative Pain pain, hypoaesthesia, or hyperaesthesia between the
Level 2A: Preoperative pain seems to increase the groups.
risk of developing chronic pain, according to some
studies [7, 11, 17]. Mesh Fixation
Fibrin glue and nonfixation techniques have been
Preoperative Chronic Pain Conditions compared with mesh fixation with staples and
Level 2B: Preoperative chronic pain conditions tackers in laparoscopic hernia operations. Reduced
such as headache, back pain, and irritable bowel early postoperative pain with the nonstapling tech-
syndrome were found to correlate significantly niques was found, but there were no differences in
with the development of chronic pain [5]. the risk for late chronic pain [27–29].

Strong Postoperative Pain No Identification of Inguinal Nerves


Level 2B: In an RCT with 319 patients comparing Level 1A: Based on three randomised studies,
three open mesh techniques, chronic pain was chronic pain after identification and division of the
found to be related to stronger pain directly after ilioinguinal nerve was similar to that after identifi-
the operation [16]. In an RCT with 867 patients cation and preservation of the nerve [30].
and 5-year follow-up comparing transabdominal Level 2B: Two cohort studies suggested that the
preperitoneal (TAPP) and Shouldice repair, no dif- incidence of chronic pain was significantly lower
ferences in late discomfort were found. However, after identification of all inguinal nerves compared
severe pain during the first postoperative week was with no identification of any nerves [30].
a risk factor for late discomfort in the Shouldice
group [18]. Intraoperative Nerve Damage
Intraoperative nerve damage in relation to the
Method of Repair development of chronic pain has been discussed.
Level 1A: The incidence of chronic pain is re- There is a lack of well-defined studies on intraop-
ported to be lower after TAPP and TEP repair erative lesions of nerves in the inguinal region in
compared to open anterior surgery, with or with- relation to development of chronic pain [9].
out mesh [9, 17, 19–22]. Other manifestations of
nerve lesions, numbness, and paraesthesia, are Reoperation for Recurrence
also fewer following laparoscopic surgery [19, 22]. Level 1B: Patients undergoing reoperative surgery
Meta-analysis of 41 trials of laparoscopic versus for recurrent hernia were at risk of developing
open groin hernia repair with 7,161 participants chronic neuralgia, with a fourfold higher rate of
(individual patient data were available for 4,165) moderate or severe chronic pain [7, 9, 17].
revealed less persisting pain and numbness after
laparoscopic repair [23].
204 Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery

Discussion tres, where the incidence of reported chronic pain


is 0–2% [32–34].
The risk of chronic postherniorrhaphy pain may The incidence rates for chronic posthernior-
be the most important outcome or quality vari- rhaphy pain derived from large register-based
able to consider in groin hernia surgery. Variables questionnaire studies have also varied [3, 11, 17,
that are most associated with an increased risk of 35]. This may also be explained by the lack of
residual postherniorrhaphy pain include nonmesh standardised principles for assessing pain. The
repair, techniques involving an anterior approach, questionnaires used have not been uniform in the
younger age, preoperative pain and preoperative definition of pain, the length of time since surgery,
chronic pain conditions, strong postoperative pain, and the intensity of pain.
lack of intraoperative identification of inguinal Among the strengths of register studies is the
nerves, and reoperation for recurrence. fact that many surgeons with varying backgrounds
Postoperative complications were found to be and (hernia) surgery experience are involved. The
26 linked to an increased risk of long-term pain in prevalence of residual pain after hernia surgery
the SHR-based questionnaire study. This is in ac- estimated in these studies is considered to mirror
cordance with two other trials [17–31]. In most population-based results, and an unselected and
studies, however, chronic pain seems not to have unbiased population is involved. Furthermore, sci-
been evaluated at all among the reported compli- entific studies with sufficient power to reveal risk
cations. These findings, correlating chronic pain factors for chronic postherniorrhaphy pain would
with complications, indicate that postoperative require considerably large samples.
complications may serve as an important vari- In the Swedish register-based questionnaire
able for improvement of surgical quality regard- study, references to the disabling effect of residual
ing risks for long-term postherniorrhaphy pain. pain with different daily activities were explored by
Among the risk factors, only the operative tech- using the IPQ, which links pain with daily func-
nique and complications can be controlled by the tion. In the IPQ, pain intensity is rated on a seven-
surgeon. step fixed-point rating scale, with steps operation-
Inguinal hernia repair, a relatively small op- ally linked with pain behaviour. The questionnaire
eration, is followed by a substantial risk of chronic has been validated and was shown to have high re-
pain. At least three nerves may be damaged during liability and validity for assessing long-term groin
the procedure. However, quantification of the level pain [15].
of pain, the exact cause, grading of the severity, Most of the published studies on laparoscopic
and social consequences of the pain have not been versus open inguinal hernia repair show a ten-
well described. dency towards less chronic pain after laparoscopic
Occurrence rates vary extensively in the litera- techniques. However, cautious interpretation is
ture, which can be explained by the lack of a uni- recommended. Many of the studies concerning
form definition of such pain and of a standardised laparoscopic treatment of inguinal hernia are of
instrument for its assessment [10]. poor quality regarding pain assessment, as pain
Assessing chronic pain was not the primary was not the primary outcome variable. But the
aim of most of the available studies. In a systematic data from the better-designed trials may suggest
review of the literature for the years 1987–2000, that the development of chronic pain is less or
the frequency of chronic pain after hernia repair, similar after laparoscopic hernia repair. The results
which was reported in 40 studies, ranged from 0% from recent randomised clinical trials compar-
to 53% [7]. Pain impairing daily activities following ing laparoscopic TEP or TAPP repair with open
groin hernia repair was reported by about 10% of tension-free mesh repair are conflicting: Some tri-
patients when asked about it 1–2 years postopera- als resulted in a lower prevalence of postoperative
tively [3]. These reports are predominantly from pain in the laparoscopic group [36–38], whereas
public hospitals and university institutions and are other trials showed no difference between the
in contrast to results from dedicated hernia cen- treatment arms [31, 39].
Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery
205 26
Future studies should focus on identifying pre- 13. Classification of chronic pain (1986). Descriptions of
operative risk factors; providing a detailed descrip- chronic pain syndromes and definitions of pain terms.
Prepared by the International Association for the Study
tion of the surgical technique (e.g. nerve identi-
of Pain, Subcommittee on Taxonomy. Pain Suppl 3:S1–
fication), the type and intensity of pain, and the S226
social consequences of the pain; and incorporating 14. SBR (Swedish Hernia Register Web site). Available at www.
a detailed postoperative follow-up with characteri- svensktbrackregister.se. Accessed 8 May 2005
sation of the pain. Most of the existing treatments 15. Fränneby U, Gunnarsson U, Andersson M, Heuman R,
Nordin P, Nyre’n O (2008) Validation of the inguinal
for chronic postherniorrhaphy pain have been un-
pain questionnaire; a novel instrument for evaluation of
successful so far and need to be further evaluated. chronic pain after hernia surgery. Br J Surg 95(4):488–
However, prevention is better than treatment, and 493
rational prevention and management techniques 16. Nienhuijs SW, Boelsen OB, Strobbe LJ (2005) Pain after
can be developed for the future only by careful anterior mesh repair. J Am Coll Surg 200(6):885–889
studies and assessment of the causes of pain. 17. Kalliomäki ML, Meyerson J, Gunnarsson U, Gordh T, Sand-
blom G (2008) Long-term pain after inguinal hernia repair
in a population-based cohort; risk factors and interfer-
ence with daily activities. Eur J Pain 12:214–225
References 18. Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE,
Rudberg C, Smedberg S, Montgomery A; SMIL Study
1. Nilsson E, Haapaniemi S (1998) Hernia registers and spe- Group (2007) Discomfort five years after endoscopic and
cialization. Surg Clin North Am 78:1141–1155 Shouldice inguinal hernia repair: a randomised trial with
2. Callesen T, Bech K, Kehlet H (1999) Prospective study of 867 patients. A report from the SMIL study group. Hernia
chronic pain after groin hernia repair. Br J Surg 86:1528– 11:307–313
1531 19. Bittner R, Sauerland S, Schmedt CG (2005) Comparison
3. Bay-Nielsen M, Perkins FM, Kehlet H (2001) Danish hernia of endoscopic techniques vs Shouldice and other open
database. Pain and functional impairment 1 year after in- nonmesh techniques for inguinal hernia repair: a meta-
guinal herniorrhaphy: a nationwide questionnaire study. analysis of randomized controlled trials. Surg Endosc
Ann Surg 223:1–7 19(5):605–615
4. Blyth FM, March LM, Brnabic AJ, Jorm LR, Williamson M, 20. The EU Hernia Trialists Collaboration (2002) Repair of
Cousins MJ (2001) Chronic pain in Australia: a prevalence groin hernia with synthetic mesh: meta-analysis of ran-
study. Pain 89:127–134 domized controlled trials. Ann Surg 235(3):322–332
5. Courtney CA, Duffy K, Serpell MG, O’Dwyer PJ (2002) 21. Koninger J, Redecke J, Butters M (2004) Chronic pain
Outcome of patients with severe chronic pain following after hernia repair: a randomized trial comparing Shoul-
repair of groin hernia. Br J Surg 89:1310–1314 dice, Lichtenstein and TAPP. Langenbecks Arch Surg
6. Schwab JR, Beaird DA, Ramshaw BJ, Franklin JS, Duncan 389(5):361–365
TD, Wilson RA (2002) After 10 years and 1903 inguinal 22. Schmedt CG, Sauerland S, Bittner R (2005) Comparison
hernias, what is the outcome for the laparoscopic repair? of endoscopic procedures vs Lichtenstein and other
Surg Endosc 16:1201–1206 open mesh techniques for inguinal hernia repair: a me-
7. Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH, ta-analysis of randomized controlled trials. Surg Endosc
Chambers WA (2003) A review of chronic pain after ingui- 19(2):188–199
nal herniorrhaphy. Clin J Pain 19(1):48–54 23. Grant AM; The EU Hernia Trialsits Collaboration (2002)
8. Winslow ER, Quasebarth M, Brunt LM (2004) Periopera- Laparoscopic versus open groin hernia repair: meta-anal-
tive outcomes and complications of open vs extraperito- ysis of randomised trials based on individual patient data.
neal inguinal hernia repair in a mature surgical practice. Hernia 6(1):2–10
Surg Endosc 18:221–227 24. Post S, Weiss B, Willer M, Neufang T, Lorenz D (2004)
9. Aasvang E, Kehlet H (2005) Chronic postoperative pain: the Randomized clinical trial of lightweight composite
case of inguinal herniorrhaphy. Br J Anaesth 95(1):69–76 mesh for Lichtenstein inguinal hernia repair. Br J Surg
10. Kehlet H, Bay-Nielsen M, Kingsnorth A (2002) Chronic 91(1):44–48
postherniorrhaphy pain: a call for uniform assessment. 25. O´Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lam-
Hernia 6:178–181 mers B, Horeyseck G (2005) Randomized clinical trial as-
11. Fränneby U, Sandblom G, Nordin P, Nyre’n O, Gunnarsson sessing impact of a lightweight or heavyweight mesh
U (2006) Risk factors for long term pain after hernia sur- on chronic pain after inguinal hernia repair. Br J Surg
gery. Ann Surg 244:212–219 92(2):166–170
12. Simons MP, Aufenacker T, Bay-Nielsen M, et al. (2009) 26. Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund
European Hernia Society guidelines on the treatment of H, Heikkinen TJ (2006) Three-year results of a randomized
inguinal hernia in adult patients. Hernia 13:343–403 clinical trial of lightweight or standard polypropylene
206 Chapter 26 · Risk Factors for Chronic Pain After Groin Hernia Surgery

mesh in Lichtenstein repair of primary inguinal hernia. Br Discussion


J Surg 93(9):1056–1059
27. Lovisetto F, Zonta S, Rora E, Mazzilli M, Bardone M, Bot-
Smeds: What is strong pain in these types of
tero L, Faillace G, Longoni M (2007) Use of human fibrin
glue (Tissucol) versus staples for mesh fixation in lap- recommendations? How should we understand
aroscopic transabdominal preperitoneal hernioplasty: strong pain?
a prospective, randomized study. Ann Surg 245(2):222– Nordin: There is no scale in the guidelines.
231 Miserez: The intraoperative nerve injury is a pre-
28. Smith AI, Royston CM, Sedman PC (1999) Stapled and
dictor for developing postoperative chronic pain?
nonstapled laparoscopic transabdominal preperitoneal
(TAPP) inguinal hernia repair. A prospective randomized However I think that we do not have any prospec-
study. Surg Endosc 13(8):804–806 tive studies concerning this special question. Can
29. Lau H (2005) Fibrin sealant versus mechanical stapling you comment on this?
for mesh fixation during endoscopic extraperitoneal in- Nordin: It is very difficult to give a comment on
guinal hernioplasty: a randomized prospective trial. Ann
this, because it is not mentioned in every trial. But
Surg 242:670–675
26 30. Wijsmuller AR, van Veen RN, Bosch JL, Lange JF, Klein- the balance if this is the main reason or not is very
rensink GJ, Jeekel J, Lange JF (2007) Nerve management difficult to see in the trials.
during open hernia repair. Br J Surg 94:17–22 Köckerling: There are two reasons why TEP gives
31. Hawn MT, Itani KM, Giobbie-Hurder A, McCarthy M Jr, the best results regarding the development of
Jonasson O, Neumayer LA (2006) Patient-reported out-
chronic postoperative pain. One is that you never
comes after inguinal herniorrhaphy. Surgery 140(2):198–
205 touch the nerves during that procedure. The sec-
32. Kark AE, Kurzer MN, Belsham PA (1998) Three thousand ond and very important point is that you normally
one hundred seventy-five primary inguinal hernia re- do not fix the mesh.
pairs: advantages of ambulatory open mesh repair using Nordin: You are right. However we have to wait for
local anesthesia. J Am Coll Surg 186:447–455
new studies comparing open a laparoscopic hernia
33. Amid PK, Lichtenstein IL (1998) Long-term results and
presentation of data of the Lichtenstein open tension- repair.
free hernioplasty. Hernia 2:89–94 Kehlet: We cannot interpret the literature as you
34. Rutkow IM, Robbins AW (1998) The mesh plug technique have done it. We should select every study were
for recurrent groin herniorrhaphy: a nine-year experience pain as outcome has been asked as a yes or no
of 407 repairs. Surgery 124:844–847
question, because it has no meaning. And ad-
35. Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H (2004) Chronic
pain after open mesh and sutured repair of indirect ingui- ditionally we should have a close look to those
nal hernia in young males. Br J Surg 91:1372–1376 patients who have severe chronic pain with social
36. Douek M, Smith G, Oshowo A, Stoker DL, Wellwood JM consequences.
(2003) Prospective randomised controlled trial of laparo- Nordin: We will consider this in the next guide-
scopic versus open inguinal hernia mesh repair: five year
lines.
follow up. BMJ 2003;326:1012–1013
37. McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Schumpelick: How many people of the Swedish
Hernia Trialists Collaboration (2003) Laparoscopic tech- hernia trial answered to your questionnaire? How
niques versus open techniques for inguinal hernia repair. many percent of the patients answered to your
Cochrane Database Syst Rev 1:CD001785 questionnaire? How representative are your data?
38. Grant AM, Scott NW, O’Dwyer PJ (2004) Five-year fol-
Nordin: In a frequency of over 80% answered to
low-up of a randomized trial to assess pain and numb-
ness after laparoscopic or open repair of groin hernia. Br J the questionnaire.
Surg 91:1570–1574 Penkert: I would like to give a short remark. Very
39. Wright D, Paterson C, Scott N, Hair A, O’Dwyer PJ (2002) often I heard about pain preoperatively as predict-
Five-year follow-up of patients undergoing laparoscopic ing factor to get chronic pain after the operation.
or open groin hernia repair: a randomized controlled trial.
We as neurosurgeons know that some patients feel
Ann Surg 235:333–337
inguinal pain which is caused by an alteration of a
nerve in the L4-L5 intervertebral joint. Therefore
ask your patients for such pains before you will
perform an inguinal hernia repair.
27

Ischemic Inflammatory Response


Syndrome as an Alternative Explanation
for Postherniorrhaphy Pain
M. Stanton-Hicks
208 Chapter 27 · Ischemic Inflammatory Response Syndrome as an Alternative Explanation for Postherniorrhaphy Pain

Introduction amination of patients with postherniorrhaphy pain,


only a small number of studies, including Aasvang
In general, moderate to severe postherniorrhaphy and Kehlet’s review, have reported that a physi-
pain occurs in 10% of patients. The incidence cal examination was done, and only one of these
is higher after recurrent repair (22%) than after included a detailed neurological examination and
initial surgery (3%) [1]. Other factors increasing careful sensory testing at 6 and 12 months [5–9].
the risk of postherniorrhaphy pain are poor post-
operative pain control, female gender, young age,
and surgical nerve damage. Although abnormal Chronic Regional Pain Syndrome
inflammatory response is also proposed as a cause
of chronic postherniorrhaphy pain, the specific The definition of CRPS includes the following:
signs and symptoms that would satisfy a diagnosis 1. The presence of an initiating noxious event or
of complex regional pain syndrome (CRPS; also cause of immobilization
known as reflex sympathetic dystrophy or Sudeck’s 2. Continued pain, allodynia, or hyperalgesia,
atrophy) are lacking. In fact, a strong argument with the pain being disproportionate to any
27 can be made that most postherniorrhaphy pain is inciting event
neuropathic in nature and is a direct expression 3. Evidence at some point of edema, changes in
of neurogenic inflammation in the territory of an skin blood flow, or abnormal sudomotor activ-
injured nerve or nerves. ity in the region of pain
This article discusses the supporting literature 4. The diagnosis is excluded by the existence of
and ideas that have been raised at this symposium. conditions that would otherwise account for
In addition, it presents the new criteria used to de- the degree of pain and dysfunction.
fine CRPS, along with recent validation studies.
In CRPS type I, previously known as reflex sym-
pathetic dystrophy or RSD, there is no evidence of
Literature Review major nerve damage [10]. CRPS type II describes
the condition in which evidence of major nerve
Preoperative risk factors for the development of damage exists [11].
postherniorrhaphy pain include severe preexisting With the introduction of a definition that is
chronic pain at any site in the body and a surgical truly descriptive and does not imply any mecha-
approach that poses a greater risk for nerve dam- nistic overtones, the sensitivity for diagnosis was
age. In their review, Aasvang and Kehlet identified increased, but at the expense of specificity. At the
a number of hernia repair studies that specified time that the taxonomy underwent its change,
pain as an adverse outcome [2]. While most stud- it was recognized that these criteria would be
ies of hernia surgery focus on measures to reduce revised and refined by longitudinal and epidemio-
the rate of recurrence, it is only during the past 10 logical studies. An initial attempt was undertaken
years that chronic postsurgical pain has received to provide internal validation through a multi-
increasing attention. These have taken the form of center study using factor analysis as a statistical
randomized controlled trials and nonrandomized technique [12]. Analysis of the data in 123 patients
studies. The role of chronic pain unassociated with revealed that patients clustered in four specifically
hernia pain in the development of posthernior- perceived groups. The first subgroup had unique
rhaphy pain is well established. Conditions such signs and symptoms indicating a disorder of pain
as chronic back pain, irritable bowel syndrome, processing. The second subgroup included skin
headache, and peptic ulcer correlate significantly color and temperature changes, indicating vaso-
with the development of chronic pain [3, 4]. motor dysfunction. In the third subgroup, signs
The role of surgical technique as it relates to and symptoms showed evidence of edema and
open versus laparoscopic repair is described else- sudomotor dysfunction. The fourth subgroup had
where in this text. With respect to neurologic ex- trophic signs and symptoms.
Chapter 27 · Ischemic Inflammatory Response Syndrome as an Alternative Explanation
209 27

⊡ Table 27.1. Modified clinical diagnostic criteria ⊡ Table 27.2. Modified research diagnostic criteria

1. Continuing pain disproportionate to any inciting 1. Continuing pain disproportionate to any inciting
event event
2. Must report at least one symptom in three of the 2. Must report at least one symptom in each of the
four categories: four following categories:
– Sensory: hyperesthesia and/or allodynia – Sensory: hyperesthesia and/or allodynia
– Vasomotor: temperature asymmetry and/or skin – Vasomotor: temperature asymmetry and/or skin
color changes and/or skin color asymmetry color changes and/or skin color asymmetry
– Sudomotor/edema: edema and/or sweating and/ – Sudomotor/edema: edema and/or sweating and/
or sweating asymmetry or sweating asymmetry
– Motor/trophic: decreased range of motion and/ – Motor/trophic: a decreased range of motion and/
or motor dysfunction (weakness, tremor, dysto- or motor dysfunction (weakness, tremor, dysto-
nia) and/or trophic changes (hair, nails, skin) nia) and/or trophic changes (hair, nails, skin)
3. Must display at least one sign in two or more of the 3. Must display at least one sign at the time of evalua-
following categories: tion in two or more of the following categories:
– Sensory: evidence of hyperalgesia (to pinprick) – Sensory: evidence of hyperalgesia (to pinprick)
and/or allodynia (to light touch) and/or deep and/or allodynia (to light touch) and/or deep
somatic pressure and/or joint movement somatic pressure and/or joint movement
– Vasomotor: evidence of temperature asymme- – Vasomotor: evidence of temperature asymme-
try and/or skin color changes and/or skin color try and/or skin color changes and/or skin color
asymmetry asymmetry
– Sudomotor/edema: evidence of edema and/or – Sudomotor/edema: evidence of edema and/or
sweating and/or sweating asymmetry sweating and/or sweating asymmetry
– Motor/trophic: evidence of a decreased range – Motor/trophic: evidence of a decreased range
of motion and/or motor dysfunction (weakness, of motion and/or motor dysfunction (weakness,
tremor, dystonia) and/or trophic changes (hair, tremor, dystonia) and/or trophic changes (hair,
nails, skin) nails, skin)
4. There is no other diagnosis to better explain the 4. There is no other diagnosis to better explain the
signs and symptoms. signs and symptoms.

⊡ Table 27.3. Summary of sensitivity and specificity for the proposed clinical and research criteria [13]

Criterion Symptoms required Signs required for Sensitivity Specificity


type for diagnosis diagnosis

Clinical 3 2 0.85 0.69

Research 4 2 0.70 0.96

External validation of the International As- tification of certain rules, which include meeting
sociation for the Study of Pain (IASP) criteria two of four sign categories and three of four symp-
compared the criteria to findings in CRPS patients, tom categories. The course of this syndrome shows
with the application of similar criteria for other extreme variability over time. Two versions of the
types of neuropathic pain. For example, a CRPS proposed diagnostic criteria–clinical and research–
patient group defined by the IASP criteria can be have been specified (⊡ Tables 27.1–27.3) [13].
compared to patients with non-CRPS neuropathic In summary, the IASP diagnostic criteria pro-
pain such as that seen in diabetic neuropathy or vide an objective means to make decisions con-
posthepatic neuralgia. To test the proposed criteria cerning the identification of those conditions
further, the ability to discriminate between CRPS that represent CRPS in which there is significant
and non-CRPS neuropathic pain requires the iden- autonomic dysfunction or other painful condi-
210 Chapter 27 · Ischemic Inflammatory Response Syndrome as an Alternative Explanation for Postherniorrhaphy Pain

tions, such as a type of neuropathic pain. The that occurs spontaneously, i.e., without external
current CRPS criteria and now improved validity evoked stimuli, a so-called ectopic pacemaker.
are designed to reduce the incidence of medical Biochemical changes in the synaptic transmis-
overutilization. The data also underscore the fact sion, changes in gene transcription, and upregula-
that a failure to acknowledge motor/trophic signs tion of the A2-δ subunits of voltage-gated calcium
and symptoms in the current criteria may prevent channels all play a part in injury-induced central
CRPS from being distinguished from other neuro- sensitization. Tumor necrosis factor δ (TNFδ), a
pathic syndromes. pain-signaling substance, sensitizes axons, and
microglia in the spinal cord are activated, both of
which increase the overall response at dorsal horn
Comparison of Inflammatory neurons, sensitization, and central transmission.
and Neuropathic Pain After Typically, loss of Aδ-fibers and C-fibers from pe-
Herniorrhaphy ripheral nerves is associated with Aß-fiber sprout-
ing with errant synapses to those second-order
If one considers the three types of pain–nocicep- neurons vacated by the loss of the Aδ-fibers and
27 tive, inflammatory, and neuropathic–the former C-fibers.
is clearly associated with the acute stimulation The role of heritable characteristics clearly in-
of mechanical, chemical, and thermal nocicep- fluences the expression of neuropathic pain. Ani-
tors. The former aspect is normally a perioperative mal studies have demonstrated these traits [14].
phenomenon, and a lack of adequate control is a The results of future studies may allow identifica-
strong risk factor for the development of chronic tion of those genes responsible for the develop-
postsurgical pain. ment of injury-induced neuropathic pain.
Chronic inflammatory pain, on the other hand, With the foregoing in mind, nerve injury oc-
results from ongoing tissue injury in response to a curring during herniorrhaphy may in itself not
chronic stimulus, such as sensitization of nocicep- cause ongoing chronic neuropathic pain. Pain pre-
tors to mechanical or chemical activity. This pe- ceding herniorrhaphy and other predisposing ge-
ripheral pain may be associated with synaptic plas- netic factors may also be important prerequisites
ticity in the spinal cord, with the development of for the development of long-standing posthernior-
central sensitization. Normally this is self-limiting, rhaphy pain in susceptible individuals. Given our
and the associated pathophysiological response contemporary uncertainty at predicting many of
will generally run a course of days or weeks, but it these factors, and given the technical variables of
could become chronic if the source of spinal input surgery (open versus laparoscopic), it would be
remains. advisable to avoid nerve injury and to certainly not
Neuropathic pain occurs after injury to nerves deliberately resect any of the nerves in the inguinal
or their transmission systems within the spinal region. Continuing improvements in morbidity
cord and brain. The hallmark of neuropathic pain with newer laparoscopic techniques should further
is loss of sensation in association with hypersen- reduce the incidence of postherniorrhaphy pain. If
sitivity. The partial or complete loss of sensory chronic postsurgical pain is associated with signs
input is a source of positive neurological activity and symptoms that fulfill the criteria for CRPS,
that is expressed by spontaneous pain and hyper- then its differential diagnosis should be distinct
sensitivity, including allodynia, hyperalgesia, and from that of neuropathic pain that is secondary
disordered sensation (dysesthesia). Furthermore, to traumatic nerve injury. Obviously, prevention
light touch or gentle pressure in deeper tissues of neuropathic pain–which, when chronic, is a
of the affected region might give rise to hyper- neurodegenerative disease, with maladaptive con-
algesia. sequences in the nervous system–should be pre-
Neuropathic pain, in contrast to inflamma- vented at all costs. Although CRPS after hernia
tory or nociceptic pain, is associated with atopic surgery is possible, its prevalence in the surgical
neurologic activity in the central nervous system hernia population is rare.
Chapter 27 · Ischemic Inflammatory Response Syndrome as an Alternative Explanation
211 27
References Smeds: What is the incidence of CRPS I?
Stanton-Hicks: I have never seen a case of CRPS I
1. Poobalan AS, Bruce J, Smith WC, et al. A review of chro- of the inguinal region. But if you have damage to
nic pain after inguinal herniorrhaphy. Clin J Pain 2003;
the nerve it is CRPS II by definition. But we have
19:48–54
2. Aasvang E, Kehlet H. Chronic postoperative pain: the case
published a case of CRPS I following breast aug-
of inguinal herniorrhaphy. Br J Anaesth 2005; 95:69–76 mentation. Therefore the inguinal region is just the
3. Courtney CA, Duffy K, Serpell MG, et al. Outcome of pa- same problem in another area.
tients with severe chronic pain following repair of groin
hernia. Br J Surg 2002; 89:1310–4
4. Wright D, Paterson C, Scott N, et al. Five year follow-up of
patients undergoing laparoscopic or open groin hernia
repair: a randomized controlled trial. Ann Surg 2002;
235:333–7
5. Heikkinen T, Bringman S, Ohtonen P, et al. Five year out-
come of laparoscopic and Lichtenstein hernioplasties.
Surg Endosc 2004; 18:518–22
6. Liem MS, van Duyn EB, van der GY, et al. Recurrences
after conventional anterior and laparoscopic inguinal
hernia repair; a randomized comparison. Ann Surg 203;
237:136–41
7. Mikkelsen T, Werner MU, Lassen B, et al. Pain and sensory
dysfunction 6 to 12 months after inguinal herniotomy.
Anesth Analg 2004; 99:146–51
8. Picchio M, Palimento D, Attanasio U, et al. Randomized
controlled trial of preservation or elective division of
ilioinguinal nerve on open inguinal hernia repair with
polypropylene mesh I. Arch Surg 2004;139:755–8
9. Verstraete L, Swannet H. Long-term follow-up after Lich-
tenstein hernioplasty in a general surgical unit. Hernia
2003; 7:185–90
10. Stanton-Hicks M, Jänig W, Hassenbusch S, et al. Reflex
sympathetic dystrophy: changing concepts and taxo-
nomy. Pain 1995; 63:127–133
11. Merskey H, Bogduk H (eds) Classification of chronic pain:
descriptions of chronic pain syndromes and definitions of
pain terms. IASP Press, Seattle, 1994
12. Harden RN, Bruehl S, Galer BS, et al. Complex regional
pain syndrome: are the IASP diagnostic criteria valid and
sufficiently comprehensive? Pain 1999; 83:211–219
13. Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Pro-
posed new diagnostic criteria for complex regional pain
syndrome. Pain Med 2007; 8(4):326–31
14. Devor M, Raber P. Heritability of symptoms in an experi-
mental model of neuropathic pain. Pain 1990; 42:51–67

Discussion

Amid: What is your definition of neuroma pre-


cisely? And what is the value of mesh material in
developing a neuroma?
Stanton-Hicks: I find it hard to believe that the
mesh acts by pressure. But I also believe that the
fibers of the mesh can cut fibers of the nerves.
28

Postoperative CRPS in Inguinal Hernia


Patients
U. Klinge, A. Fiebeler, M. K. Tur
214 Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients

Introduction erations and the extent of local scar tissue. Each of


these factors or a combination of them may favour
Chronic pain is a frequent result after surgical the development of pain and, correspondingly,
hernia repair and probably the most difficult com- will influence the success of a revision operation.
plication to treat. Whereas we have several excel- Whereas pain caused by entrapment through a clip
lent options for handling a recurrence, therapy of may be cured causally by neurectomy [1], pain due
chronic pain may be frustrating, at least in some to pathology of the wound healing process (involv-
patients, and causes a lot of trouble for the surgeon ing age, smoking, local nerve regeneration, etc.) is
as well as for the patient. Almost the majority more complex and difficult to address.
of patients report some kind of mild complaints Generally, pain is classified as either nocicep-
following hernia repair, but some patients suffer tive, which represents a physiological signal from
considerably. Feeling that they cannot live with injured tissue (= wound pain), or neuropathic, in
this pain, they look for any treatment to get rid of which a malfunction of a nerve leads to pain signal-
it, and they often undergo one surgical revision ling to the brain. Whereas the first is assumed to
after another. disappear after healing of the wound, it is mainly
Usually, one of the first options is a revision the latter that is accused of causing chronic pain.
operation, assuming that some of the local nerves Recently, Aasvang et al. [2] demonstrated that
are entrapped in sutures, clips, or scar tissue. In large- and small-fibre dysfunction can be detected
28 these patients, a neurectomy is usually performed. in all patients following hernia repair but is more
Although in some cases it may not be possible to profound in pain patients. Correspondingly, some
identify and resect all three nerves (ilioinguinal sort of nerve dysfunction seems to be common
nerve, iliohypogastric nerve, and genital branch after surgery in the groin.
of the genitofemoral nerve), or the morphological However, classification as neuropathic pain
analysis of the nerves may reveal no significant pa- seems to be too nonspecific for selecting therapeu-
thology, most patients show complete or partial re- tic options. In a 1999 review in Lancet, Woolf and
lief of their complaints. However, in some patients Mannion [3] stated the following:
the complaints remain, sometimes even getting ▬ Pharmacotherapy for neuropathic pain has
worse, starting a series of many fruitless attempts been disappointing.
to alleviate the discomfort. If these patients had ▬ There is no treatment to prevent the develop-
been treated with adequate neurectomy of all three ment of neuropathic pain.
nerves, what else might be the reason for such ▬ There is no treatment to adequately, predicta-
failures, and how can we identify those patients bly, and specifically control established neuro-
beforehand to avoid frustrating operations? pathic pain.
▬ There are no predictors to indicate, which pa-
tient will develop neuropathic pain.
Patients with Neuropathic Pain: ▬ As a tool to define treatment strategy, symp-
Subgroup with Complex Regional toms alone are not useful because they are not
Pain Syndrome Not Responding equivalent to mechanisms.
to Surgical Therapy
Although consideration of neuropathic pain is too
There is no doubt that pain is related to nerves and inaccurate, this view neglects to account for two
that there are many ways to cause or intensify pain. different mechanisms that may contribute to nerval
But apart from technical reasons, which depend on function: either direct damage or pathological trig-
the surgical procedure and the surgeon, patient- gering by perinerval stimuli. In accordance, Aasvang
related aspects must be considered, too. Several et al. [2], who investigated postoperative complaints
clinical studies have demonstrated that pain is after mesh repair of groin hernia, concluded that
mainly a problem of younger patients and that the »whether the underlying pathophysiological mecha-
risk increases with the number of previous op- nisms are related to direct intraoperative nerve in-
Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients
215 28
jury or nerve injury due to an inflammatory (mesh) patient suffered from paraesthesia, possibly caused
response remains to be determined.« by damage of the anterior cutaneous branch of the
In this context, it may be helpful to adopt the femoral nerve, although another neurologist sus-
experiences of other medical fields. Stanton-Hicks pected damage to the genitofemoral nerve. After
published a review on the concept of complex explantation of a heavyweight polypropylene mesh
regional pain syndrome (CRPS) [4]. CRPS is char- that had shrunken from 15×10 cm to 13×4.5 cm,
acterised by the presence of continuing pain, al- the patient showed a complete recovery.
lodynia, or hyperalgesia after nerve injury that is In contrast, a patient with expected CRPS, who
not necessarily limited to the distribution of a spe- received a suture repair of a primary hernia rep-
cific nerve and is often accompanied by oedema, resents a totally different history. In this example,
changes of skin blood flow, or abnormal sudomo- within the first 2 weeks the patient underwent two
tor activity. Two types of CRPS have been recog- revisions, the first for pain and the second for hae-
nised. Type I corresponds to reflex sympathetic
dystrophy and occurs without a definable nerve
lesion. Type II, formerly called causalgia, refers to
cases in which a definable nerve lesion is present,
but this is still controversially discussed [5].
Despite the extreme variability of the patients’
symptoms–which are quite similar to Sudeck’s at-
rophy–there seems to be a subgroup of patients
who suffer in an outstandingly severe manner
from their pain. Often, the pain is not restricted to
a circumscribed area that can be related to a nerve;
instead, it is characterised by intense, burning
sensations and is poorly localised, appearing rather
as neuropathic inflammatory pain, with an inflam-
matory reaction triggered by neural malfunction.
It may be hypothesised that these patients may ⊡ Fig. 28.1. Explanted polypropylene mesh from patient with
not be treatable by operations because any surgical chronic pain, with growth of nerve fibre directed towards the
revision might boost the local disturbance of tissue polypropylene filament
integrity [6].
In cases of nerve injury, the axonal regenera-
tion after Wallerian degeneration fails to reinner-
vate the proper end organs in these patients. In an
analysis of mesh samples that had been explanted
because of chronic pain, some samples revealed
misguided growth of the nerves directed towards
the filament, indicating an inhibition of Schwann
cells by foreign body reaction (⊡ Fig. 28.1). In oth-
ers, the neuropathic inflammation was accompa-
nied by fibrotic degeneration of nerves with fo-
cal axonal degeneration and regeneration of axon
sprouts into the surrounding tissue (⊡ Fig. 28.2).
The following patient history may be a typical
example of a patient with chronic pain that can be
resolved by operation. The pain started with the ⊡ Fig. 28.2. Explanted polypropylene mesh from patient with
implantation of a mesh, with no clip fixation, in the chronic pain, with axon sprouts regenerating into the sur-
right groin for a recurrent hernia. Immediately, the rounding tissue
216 Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients

matoma. Three months later, a third revision was so entrapment of a nerve had been assumed but
done with neurectomy. After transcutaneous elec- not proven.
tric stimulation for more than 1 year, retroperitoneal The patients were contacted by phone, and the
neurectomy of the iliohypogastric and ilioinguinal success of therapy was coded as follows:
nerves followed, which resulted in temporary im- 1. Complete relief (CR)
provement for only 2 weeks. One year later, laparo- 2. Still experiencing intermittent attacks (IA)
scopic extraperitoneal revision and reneurectomy 3. No improvement despite revision (NI)
of the genitofemoral nerve did not lead to any im- 4. Conservative therapy (CT).
provement. A fourth revision 1 year later for recur-
rence was combined with lateral neurectomy and All of the patients had undergone at least one
gave relief only for some weeks. The patient’s final surgical revision, and only three had submitted
status is characterised by severe pain in the entire to a conservative therapy. The remaining 40 were
lower abdomen, both at rest and under strain, and treated with either neurectomy or explantation
a demanding consumption of opioids as painkillers, of a heavyweight small-pore polypropylene mesh.
and has been leading to inability to work any longer. Results provided by telephone revealed complete
Because several patients have experienced the relief in 13 patients, intermittent attacks in 13, and
same series of frustrating operations finally lead- no improvement in 14.
ing to invalidity, a specific »response« of these Comparing the various therapeutic outcomes,
28 patients to the tissue injury of a groin hernia repair patient age did not show any significant differ-
may be suspected. In this regard, the concept of ence among the four groups. Interestingly, the
CRPS may offer a valuable tool for selecting pa- mean age of all patients was considerably lower
tients at high risk for poor outcomes after surgical (46.8±12.7 years) than the mean age of patients
revision–if it is possible to identify patients in this with groin hernia disease.
subgroup preoperatively. These patients may get Although males were slightly more likely to
a better benefit from nonsurgical therapies, such be rid of their pain, this did not reach statistical
as local therapy with anti-inflammatory drugs or significance.
therapeutic injections of glucocorticoids [7]. As an attempt to identify patients with CRPS,
About 30–40% of patients are considered to we assumed that these patients do not have pain
suffer from pain that may be classified as neuro- that occurs immediately after operation and then
pathic [8, 9], but is not clear whether it is a part remains constant but instead have pain that devel-
of CRPS. Which patients will probably get some ops after a considerable delay and then increases
benefit from an operation, and which will not? constantly (⊡ Fig. 28.3). Patients with CRPS are not

Preoperative Assessment of CRPS

To find an answer, we analysed 186 patients who


had been seen in our clinic for chronic pain in Pain
the abdominal wall in the years 2002–2007. In 52
patients (34%), the pain was related to previous
hernia repair in the groin. Therapeutic success
Time
could be verified in 43 of them. Many of these
patients had had multiple previous operations, and ⊡ Fig. 28.3. Time course of pain after hernia repair. Direct
the causal relevance of the specific impact is hard damage to the nerve, such as by entrapment in a clip or su-
ture, is assumed to occur directly postoperatively, remaining
to identify. However, they reported rather complex
constant afterwards. This is seen in most patients. In contrast,
individual histories. The youngest patient was 16 some patients are pain-free for some time after the operation,
years old. The pain occurred immediately after but then after a delay of months or even years they newly
hernia repair and was resolved by surgical revision, develop pain, which constantly increases
Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients
217 28
expected to respond to a diagnostic pain block
⊡ Table 28.1. Complex regional pain syndrome (CRPS)
with local anaesthesia within 1 h, and they are not scores of 43 patients with chronic pain. Pain: 1= im-
expected to show any significant relief. In patients mediate pain postoperatively; 2= delay/increasing
without CRPS, it should be possible to relate the pain. Block with local anaesthetics: 1= relief; 2= no
relief. Anatomical relationship: 1= related to nerve
pain to the supply area of certain nerves, whereas area; 2= diffuse/not related to nerve area. Success of
in patients with CRPS it is not. therapy: CR complete relief; IA intermittent attacks;
To analyse patients, we created a CRPS scoring NI not improved; CT conservative therapy
system consisting of the following three aspects:
Sum of CRPS 3 4 5 6
1. For pain: 1= immediate postoperative pain; score points
2= delay/increasing pain
n 23 8 9 3
2. For block with local anaesthetics: 1= relief;
2= no relief % 53% 19% 21% 7%
3. For anatomical relationship: 1= related to nerve Therapeutic CRPS
area; 2= diffuse/not related to nerve area. outcome suspected

CR 11 3
To apply this CRPS score, we assigned 2 points to
IA 7 4 2
those signs assumed to indicate CRPS and only
1 point for the others (⊡ Table 28.1). Correspond- NI 5 1 7 1
(= CRPS ?)
ingly, a sum of 6 points indicates the presence of
CRPS, whereas 3 points reflects a low probability CT 3
(= CRPS ?)
for CRPS. Therefore, the success of a surgical

No CRPS CRPS
5

1
r=0.6, p< 0.01

0
2 3 4 5 6 7
CRPS score
⊡ Fig. 28.4. Patients (n=43) treated in the surgical depart- syndrome (CRPS), see Table 28.1. Sums vary between 3 and
ment of the RWTH Aachen 2002–2007 for chronic pain after 6 points; 3 points are assumed to not represent CRPS, whereas
groin hernia repair. Therapy success is coded as 1= complete 6 points are suspected to represent CRPS. The diameter of
relief, 2= intermittent attacks, 3= not improved, 4= conservati- the points is related to the number of patients with a similar
ve therapy. For method of scoring for complex regional pain constellation
218 Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients

therapy should be highest for patients without References


CRPS and lowest for patients with CRPS. Indeed,
the analysis of correlation shows a statistically sig- 1. JP Miller, F Acar, VB Kaimaktchiev, SH Gultekin, KJ Burchiel:
Pathology of ilioinguinal neuropathy produced by mesh
nificant relationship between our CRPS scores and
entrapment: case report and literature review. Hernia
the success of therapy, confirming that patients 2008, 12:213–6
scoring 5 and 6 should be treated conservatively 2. EK Aasvang, B Brandsborg, B Christensen, TS Jensen, H
(⊡ Fig. 28.4). The correlation coefficient r between Kehlet: Neurophysiological characterization of postherni-
the therapy index and the CRPS score was 0.6. otomy pain. Pain 2008, 137:173–81
3. CJ Woolf, RJ Mannion: Neuropathic pain: aetiology, sym-
However, six of 21 patients, whose treatment suc-
ptoms, mechanisms, and management. Lancet 1999,
cess was rated as NI or CT scored less than 5 points 353:1959–64
on the CRPS score, indicating that this scoring 4. M Stanton-Hicks: Complex regional pain syndrome. Anes-
system needs to be improved, particularly with re- thesiol Clin North Am 2003, 21:733–44
gard to sensitivity. Fortunately, only two of the pa- 5. GD Schott: Complex? Regional? Pain? Syndrome? Pract
Neurol 2007, 7:145–57
tients with successful therapies (CR, IA) had more
6. H Li, W Xie, JA Strong, JM Zhang: Systemic antiinflamm-
than 4 points in their CRPS scores, confirming the atory corticosteroid reduces mechanical pain behavior,
specificity of the score for excluding patients from sympathetic sprouting, and elevation of proinflammatory
surgical revision. cytokines in a rat model of neuropathic pain. Anesthesio-
logy 2007, 107:469-77
28 7. S Aroori, RA Spence: Chronic pain after hernia surgery–an
informed consent issue. Ulster Med J 2007, 76:136–40
Conclusion
8. S Massaron, S Bona, U Fumagalli, F Battafarano, U Elmore,
R Rosati: Analysis of post-surgical pain after inguinal her-
The concept of CRPS has proven to be helpful nia repair: a prospective study of 1,440 operations. Hernia
for understanding why some patients may fail 2007, 11:517–25
9. MJ Loos, RM Roumen, MR Scheltinga: Classifying post-
to respond to surgical therapy. In many patients,
herniorrhaphy pain syndromes following elective ingu-
chronic pain is caused by several different local inal hernia repair. World J Surg 2007, 31:1760–1765; dis-
reasons that can be influenced technically, either cussion 1766–1767
by neurectomy or mesh explantation. The pres-
ence of CRPS represents a systemic biological
problem of tissue response that will not respond
to any local repair, a concept that is already widely Discussion
accepted for the treatment of causalgia or Sudeck’s
atrophy, both diseases with considerable similari- Kehlet: In my opinion you are on the wrong track.
ties. The assumption that 25% of the patients But that is the reason why we are here to discuss
with chronic pain possibly have CRPS is well in this problem. How can you say that we should
accordance with the failure rate of 20–30% after not operate on patients with chronic noziceptor
surgical therapy. pain? I find no evidence for that. To say that there
In the future, the validity of the proposed are CRPS I and II is too simple, there are more
CRPS scoring system should be confirmed by subtypes. I ask for mulitcentre collaboration with
comparing it with other methods and measure- detailed neurophysiological, psychological and ge-
ments. Despite the extremely complex pathogen- netically characterization of the patients to find
esis of chronic pain, it appears to be possible to out which type of chronic pain we have. We have
identify patients with CRPS preoperatively. Future to look at the spinal and cortical mechanisms of
studies will show whether our arbitrary CRPS pain productions and separate them out to differ-
score can be improved by integrating further fac- ent groups. And then we should study the different
tors, such as a history of painkillers, detectable types of intervention.
alteration of skin temperature, modified skin re- Klinge: First of all is a question of definition. It is
action to heat and cold stimulus, signs of atrophy, not precisely clear what is noziceptive pain and
or a pathological sweat secretion test. what is precisely CRPS. There are still a lot of
Chapter 28 · Postoperative CRPS in Inguinal Hernia Patients
219 28
controversial issues in this matter. Second point Kehlet: There is one thing that we can conclude:
is that there are so many factors that are respon- We don´t understand this problem completely. We
sible. And if you include all these factors which need multicentre trials to collect enough patients,
are responsible for such a pain you have a dif- because the problem is too complicated.
ferent treatment for every patient. And probably Amid: Two third of the patients did not have mesh
this will not be helpful for our young surgeons in repair. How can you correlate mesh repair with the
the outpatient clinics. This is such a proposal to pain if it is not a technical error?
identify subgroups. Thought this cannot reflect the Klinge: Just briefly. In our laboraty we have col-
specific individual situation. But the main question lected about 600 mesh explants. In nearly 94% of
is whether to make a neurectomy or not. the patients in whom the explantation was done
Muschaweck: You recommended a local treatment due to chronic pain it was a heavy-weight mesh
with local anesthesia. What do you think about a small porous polypropylene mesh.
mixture of local anesthesia and cortisone?
Klinge: First of all there is clear evidence that there
is beneficial effect of combination with steroids in
therapeutically injection. The other point is the di-
agnosis. There is difference in those patients who
do not respond to the injection and feel pain even
while the injection comparing to those patients
who respond for instance at least for one hour to
the injection of local anesthesia.
Stanton-Hicks: What diagnostic criteria did you
use to diagnose the CRPS? What clinical signs and
symptoms?
Klinge: In this preliminary study we only looked to
the patients with chronic pain and grouped them
to two groups. I am sure that this is not a good
definition of CRPS. It is probably a sub grouping of
patients with chronic pain. Probably CRPS is not
the right term but it is helpful.
Smeds: I want add a practical thing. As we know
in 80% of the patients with chronic pain the pain
will improve within the first year after the opera-
tion. Therefore we should at least wait one year be-
fore performing another operation.
Klinge: There are may be different ways how to
treat a decision tree to make an immediate opera-
tion or not. I am convinced that the most patients
we will not see within the first 6 month after op-
eration.
Köckerling: Before we name this problem a Sudeck
of the groin we absolutely should be sure that
there are no morphological reasons for the chronic
pain.
Schumpelick: What to do now? Is there some
practical advice for a practical surgeon? What to
do with a patient with pain in the groin?
Klinge: I want to simplify it.
29

Chronic Pain After Open Mesh Repair


of Incisional Hernia
M. Kurzer, A. Kark, S. T. Hussain
222 Chapter 29 · Chronic Pain After Open Mesh Repair of Incisional Hernia

Introduction patients still had some symptoms of discomfort,


although most were infrequent and mild. However,
Chronic or long-term pain following open inci- 11% of patients described the pain as moderate to
sional hernia repair is poorly documented. Tra- severe, and 7% said it limited their activities. In
ditionally, studies of incisional hernia repair have addition, 34% thought they could feel the mesh.
focussed only on short-term complications (infec- In this article, McLanahan et al. also stressed the
tion, haematoma), major morbidity, hospital stay, importance of patient satisfaction and of asking
and recurrence. Chronic pain (defined as pain patients for their assessment of the operation.
persisting more than 3 months postoperatively [1]) Burger et al. [5] and Pajaanen and Hermunen
has not been perceived as a significant issue, a [6] found the incidence of long-term pain to be
similar situation to that for inguinal hernia repair 13% and 20%, respectively, after sublay mesh repair.
until recently. Indeed, a recent review of surgical Kingsnorth, using an onlay technique, reported
treatment of incisional hernia [2] did not mention similar figures [7]. Two of these studies [6, 7] found
postoperative pain at all. However, with surgeons’ that in 9% or 10% of patients, respectively, this pain
increasing awareness of the importance of patient- limited their daily activities. The list includes both
reported outcomes [3], long-term pain following onlay and sublay techniques, with an incidence of
incisional hernia repair is increasingly recognised chronic pain ranging from 13% to 60%.
as a significant clinical problem. Although it can Some of this wide variation may relate to how
occur following open or laparoscopic repair, this the pain was assessed. In a study of three differ-
article will confine itself to the problem of chronic ent techniques reported by Korenkov et al., an
29 postoperative pain after open mesh repair. extremely high proportion, 61%, of patients in
the onlay mesh group reported postoperative pain
[8]. Infection complications led to this multicentre
How Common Is Chronic Pain After study being halted, and it may be that variations in
Open Incisional Hernia Repair? technique and other technical factors were respon-
sible for this high incidence of pain and complica-
McLanahan and colleagues were among the first to tions. Other groups have also recognised that pain
document chronic pain following incisional hernia following open incisional hernia repair is a real is-
repair and discuss its clinical significance [4]. At sue that should be addressed [9, 10]. These studies
12 months following a sublay mesh repair, 45% of are listed in ⊡ Table 29.1.

⊡ Table 29.1. Studies addressing pain following open incisional hernia repair (nr not recorded)

First author Year Mesh n Follow-up, Discomfort/ Severe Limitation


position months some pain, % pain, % in activities, %
Sugerman [10] 1996 Prefascial 98 20 6 nr nr
MacLanahan [4] 1997 Sublay 106 >12 55 11 7
Müller [23] 1998 Sublay 41 17 7–30 nr 30
Martin-Duce [11] 2001 Sublay 284 72 28 nr nr
Korenkov [8] 2002 Onlay 54 12 61 nr nr
Paajanen [6] 2004 Sublay 84 36 20 4 10
Burger [5] 2004 Sublay 84 81 20 nr nr
Machairas [9] 2004 Onlay 43 54 7 nr nr
Kurzer [18] 2008 Sublay 106 95 3 0 0
Kingsnorth [7] 2008 Onlay 116 15 18 nr 9
Chapter 29 · Chronic Pain After Open Mesh Repair of Incisional Hernia
223 29
Aetiology of the Pain been recognised by French surgeons following in-
sertion of large pieces of mesh or sublay repair of
Martin-Duce et al. reported a 28% incidence of massive incisional hernias [12, 13].
chronic postoperative pain in 152 incisional hernia
patients [11]. The pain was felt laterally along the
spigelian line and was thought to be related to the Mechanism of Mesh-Associated
method of mesh attachment, with nonabsorbable Pain
sutures. Its incidence decreased when the surgeons
modified their technique of mesh attachment and There is now ample evidence that nonabsorbable
used absorbable sutures. Paajanen and Hermunen, alloplastic meshes made of polypropylene or poly-
too, believed that nonabsorbable peripheral su- ester excite an inflammatory foreign body reaction
tures were the cause of postoperative pain, due to that progresses to chronic inflammation and fibro-
either tension in the sutures or nerve entrapment sis [14, 15]. This reaction is related to the size and
[6]. Costalat et al. [12] and Cubertafond et al. [13] type of the mesh fibres and is also host dependent.
held similar views. The aetiology of this pain may Most research has focused on polypropylene mesh,
be similar to that seen following mesh attachment in which the total amount of polypropylene and
at its periphery with transfascial sutures in laparo- the pore size are probably the chief determinants
scopic repair. of the extent and duration of the inflammatory
The long-term follow-up of a Dutch ran- response [16, 17]. With small-pore (sometimes
domised trial found the incidence of scarring or called heavyweight) meshes, the areas of scar tis-
superficial pain to be similar whether a sutured sue that form around individual fibres meet and
or mesh repair was used [5]. However, abdominal coalesce, a phenomenon known as bridging. The
pain was less frequent in the mesh repair patients, consequent formation of a thick, rigid scar plate is
and the researchers concluded that much of the responsible for the discomfort and stiffness felt by
discomfort was due to midline tension associ- the patient. Histological examination of explanted
ated with fascial closure, which is more likely in mesh in this situation has also demonstrated nerve
sutured-only patients. entrapment within the scar tissue, another factor
in the aetiology of the pain. With pore sizes greater
than 4 mm, there is a less acute inflammatory reac-
Mesh as the Cause of Pain? tion, fibrosis is limited to the perifilamentary area,
and the pores between the fibres are filled with fat
Perhaps because our recent recognition of chronic rather than fibrotic scar tissue.
pain as an important sequela of incisional hernia
repair has coincided with the widespread use of
mesh, the mesh itself has been thought to be a Other Complaints with Various
causative factor. Meshes
The Aachen group, who have extensive experi-
ence with the sublay mesh repair technique, have A study comparing three different meshes found
found that a significant proportion of patients that 59% of patients implanted with one type of
complain of paraesthesia and discomfort at the standard-weight mesh complained of paraesthesia
periphery of the mesh, as well as a syndrome of ab- in the region of the periphery of the mesh, com-
dominal stiffness after open mesh incisional her- pared with only 4% of patients implanted with a
nia repair. In a number of patients these symptoms lightweight mesh (⊡ Table 29.2) [17]. The tech-
are troublesome enough to require further surgery nique of three-dimensional stereography of the
and mesh removal. Histological examination of the abdominal wall in postrepair patients showed an
explanted mesh has revealed extensive scar tissue, increase in stiffness, and this occurred whichever
forming what is termed a scar plate. This sensation mesh was used. However, the extent of stiffness
of abdominal restriction, or corsage, had earlier increased with mesh weight and was inversely
224 Chapter 29 · Chronic Pain After Open Mesh Repair of Incisional Hernia

⊡ Table 29.2. Symptoms following sublay incisional her- ⊡ Table 29.3. Postoperative questionnaire to incisional
nia repair with different meshes (from Welty et al. [17]) hernia patients

Symptoms % Marlex Atrium Vypro 1. Can you remember if you had much pain or dis-
comfort from the hernia before it was repaired or
Paraesthesiae 59 16 4 was there just a swelling?
2. If you had pain or discomfort before the operation,
Complaints, 17 16 7
is this now better or improved?
heavy work
3. Do you have abdominal or scar pain now?
Complaints, 17 0 4 4. Did you think about just leaving it?
daily activities 5. Are you pleased/satisfied with the operation?
6. Is the repair still sound or do you think the hernia
Complaints at rest 9 3 0 might have come back?

proportional to mesh pore size. Moreover, the


⊡ Table 29.4. Questionnaire replies, 68/106
stiffness in the lightweight (or large pore size)
group diminished over time. This study also found n=68 Yes No
that restricted mobility of the abdominal wall and
1 Preoperative pain? 47 (70%) 21 (30%)
an increase in the rate of patient complaints cor-
related with the morphological development of a 2 Pain better now? 45 (95%) 2 improved
29 strong scar plate [17].
3 Any pain now? 5 63
The clinical evidence is, however, slightly
equivocal, as a recent randomised multicentre 4 How disabling? 0 68
study of 165 patients failed to show a signifi- 5 No operation
cant difference (clinically or statistically) between option?
standard-weight and lightweight mesh in terms of
6 Satisfied? 68 0a
interference with daily activities.
7 Recurrence 0 68
aNeutral
or no response on questionnaire
Results from the British Hernia Centre

In January 2008 we wrote to 106 patients who had


undergone open mesh incisional hernia repair at Summary and Conclusion
our institution over the previous 10 years [18].
The technique used was an open sublay repair Clinically important pain following open mesh
with standard-weight polypropylene mesh, and the repair of incisional hernia has an incidence of
overall recurrence rate was 4%. At the time of approximately 10–20%. It can occur after both
writing, 68 patients had replied to the question- onlay and sublay techniques, although the nature
naire (⊡ Table 29.3). Before the operation, 70% of of the pain may differ. The aetiology of the pain
patients had some degree of pain or discomfort, is probably multifactorial and includes tension in
and in the vast majority this was improved af- the repair, nerve entrapment in sutures, and mesh-
ter operation (⊡ Table 29.4). Three patients who associated inflammation and scar plate formation.
had not had preoperative pain had symptoms of Whether it is related to preoperative symptoms (as
discomfort postoperatively, although this did not in inguinal hernia) is a question that has not yet
interfere with their daily activities, and they were been addressed.
pleased to be rid of their hernia. In this retrospec- At present we also lack data regarding what
tive study, chronic postoperative pain was not seen patients think about these symptoms and how
as a clinical problem. much these symptoms affect daily activities. Is
Chapter 29 · Chronic Pain After Open Mesh Repair of Incisional Hernia
225 29
mild postoperative discomfort a price that pa- 11. Martin-Duce A, Noguerales R, Villeta R, et al. (2001). Modi-
tients are willing to pay to be rid of an uncom- fications to Rives technique for midline incisional hernia
repair. Hernia 5:70–72
fortable, unsightly, enlarging, and potentially life-
12. Costalat G, Noel P, Vernhet G (1991). Technique de cure
threatening abdominal swelling? This information d’eventration par prothese parietale. Ann Chir 45:882–888
will be acquired only through accurate preop- 13. Cubertafond P, Sava P, Gainant A, et al. (1989). Cure
erative assessment, more assiduous follow-up, and chirurgical des eventrations post-operatoires par plaque
recognition of the importance of patient-reported prothetique. Chirurgie 115:66–71
outcomes [19–21]. Indeed, the whole subject of 14. Klinge U, Klosterhalfen B, Muller M, et al. (1999). Foreign
body reaction to meshes used for the repair of abdominal
incisional hernia repair is hampered by a »lack of wall hernias. Eur J Surg 165:665–673
prospective high-quality studies« [21, 22]. Future 15. Klosterhalfen B, Klinge U, Hermanns B, et al. (2000). Pa-
progress and improved results will come not only thology of traditional surgical nets for hernia repair after
from technical factors (including improvements long-term implantation in humans. Chirurg 71:43–51
in mesh technology) but also from better under- 16. Klosterhalfen B, Junge K, Hermanns B, et al. (2002). Influ-
ence of implantation interval on the long-term biocom-
standing of the indications for surgery and the
patibility of surgical mesh. Br J Surg 89:1043–1048
development of guidelines for appropriate patient 17. Welty G, Klinge U, Klosterhalfen B, et al. (2001). Functio-
selection. nal impairment and complaints following incisional her-
nia repair with different polypropylene meshes. Hernia
5:142–147
References 18. Kurzer M, Kark A, Selouk S, et al. (2008). Open mesh repair
of incisional hernia using a sublay technique: long-term
follow-up. World J Surg 32:31–36
1. International Association for the Study of Pain (1999).
19. Bitzer EM, Lorenz C, Nickel S, et al. (2008). Patient-reported
Classification of chronic pain. Description of chronic pain
outcomes in hernia repair. Hernia 12:407–414
syndromes and definitions of pain terms. Pain Suppl 3:S1–
20. Nieuwenhuizen J, Kleinrensink GJ, Hop WC, et al. (2008).
226
Indications for incisional hernia repair: an international
2. Cassar K, Munro A (2002). Surgical treatment of incisional
questionnaire among hernia surgeons. Hernia 12:223–225
hernia. Br J Surg 89:534-545.
21. Nieuwenhuizen JA, Halm J, Jeekel J, et al. (2007). Natural
3. Holt PJ, Poloniecki JD, Thompson MM (2008). How to im-
course of incisional hernia and indications for repair.
prove surgical outcomes. Br Med J 336:900–901
Scand J Surg 96:293–296
4. McLanahan D, King L, Weems C, et al. (1997). Retrorectus
22. Muller-Riemenschneider F, Roll S, Friedrich M, et al.
prosthetic mesh repair of midline abdominal hernia. Am J
(2007). Long-term effectiveness of interventions promo-
Surg 173:445-449
ting physical activity: a systematic review. Surg Endosc
5. Burger JW, Liujendijk RW, Hop WC, et al. (2004). Long-term
21:2127–2136
follow-up of a randomized controlled trial of suture versus
23. Müller M, Klinge U, Conze J, Schumpelick V. (1998). Abdo-
mesh repair of incisional hernia. Ann Surg 240:578–583;
minal wall compliance after Marlex mesh implantation for
discussion 83–85
incisional hernia repair. Hernia 2:113–117
6. Paajanen H, Hermunen H (2004). Long-term pain and re-
currence after repair of ventral incisional hernias by open
mesh: clinical and MRI study. Langenbecks Arch Surg
389:366–370
7. Kingsnorth A (2008). Open onlay mesh repair for major Discussion
abdominal wall hernias with selective use of components
separation and fibrin sealant. World J Surg 32:26–30
Conze: Every large hernia was once a small hernia.
8. Korenkov M, Sauerland S, Arndt M, et al. (2002). Rando-
mized clinical trial of suture repair, polypropylene mesh Therefore I think that there is a development of
or autodermal hernioplasty for incisional hernia. Br J Surg size, but you didn’t mention it in your talk.
89:50–56 Kurzer: In my opinion the size of the hernia stays
9. Machairas A, Misiakos EP, Liakakos T, et al. (2004). Incis- stable at one point with a scary border.
ional hernioplasty with extraperitoneal onlay polyester
Conze: Another thing is that we have to differenti-
mesh. Am Surg 70:726–729
10. Sugerman HJ, Kellum JMJ, Reinesm HD, et al. (1996).
ate emergency cases. About 2–3% of emergency
Greater risk of incisional hernia with morbidly obese than operations were done because of incarcerated her-
steroid-dependent patients and low recurrence with pre- nias. Therefore it is important to differentiate who
fascial polypropylene mesh. Am J Surg 171:80–84 is of risk for developing an incarceration.
30

Clinical Results After Open


Mesh Repair
V. Schumpelick, M. Binnebösel, J. Conze
228 Chapter 30 · Clinical Results After Open Mesh Repair

The incidence of incisional hernia formation re- First of all, we are confronted with a mix of
mains unchanged between 10% and 20%, depend- terms: incisional or ventral hernia? These are often
ing on the length of follow-up [1]. It is still one of used as synonyms, as well as epigastric and um-
the most common complications after abdominal bilical hernia. This does not make sense because
surgery. Today a large variety of surgical options the anatomy and pathophysiology of primary and
for incisional hernia repair are available [2–4]. On umbilical hernias differ from that for incisional
the basis of data from 2006, approximately 40,000 hernias.
incisional hernia repairs were performed in Ger- Second, within the group of incisional her-
many. Although the results of conventional suture nias, no differentiation is made between the differ-
repair are known to have a recurrence rate of up to ent hernia locations: median, paramedian, lateral,
60% depending on the time of follow-up, almost transverse, subxiphoid oblique, or flank incisions.
every second incisional hernia is still repaired with This is due to lack of a classification system for
a suture repair. The other half are performed with abdominal wall hernias. There have been several
the help of nonresorbable mesh prostheses. attempts in the past to develop a classification to
Unfortunately, the operative coding system make comparison of different surgical procedures
does not facilitate differentiation of the surgical possible. In 1998 there was a first expert meet-
procedures. There is great variability in the place- ing under the guidance of the GREPA/European
ment of the mesh within the abdominal wall: in- Hernia Society (EHS) to create a classification
traabdominal as an intraperitoneal onlay mesh, for incisional hernias. Besides the location of the
epifascial onto the anterior fascia (onlay), or be- previous incision, the experts took defect size and
hind the muscles onto the posterior rectus sheath reducibility into account, but no proposal resulted
(retromuscular/sublay). Another important techni- from this meeting [5]. Several other attempts fol-
cal aspect is the intended role of the mesh–whether lowed, but to date, none has found its way into the
30 it is used for augmentation (reinforcement) or as a clinical routine. Too many parameters need to be
replacement (bridging of the defect) of the abdom- considered: location, defect size, width or length
inal wall (⊡ Fig. 30.1). This shows the problem and of the defect area, symptomatology, reducibility,
limitations of a review of open mesh techniques: number of recurrences or visibility. One parameter
We still have no sufficient data available! that all classification attempts include is the size of

onlay

sublay

ipom
AUGMENTATION

onlay

sublay

ipom
DEFECT-BRIDGING

⊡ Fig. 30.1. Role of mesh


Chapter 30 · Clinical Results After Open Mesh Repair
229 30
the hernia defect. But there is a vast difference be- also one of the major concerns in open incisional
tween a midline hernia defect of 20 cm width and hernia repair, but there is usually no differentia-
5 cm length compared to a defect of 5 cm width tion between superficial wound infection and deep
and 20 cm length, though the total defect size is mesh infection. Must a local erythema be consid-
the same. Also, some surgical techniques open ered an infection? Again, no definition has found
the complete scar of the previous incision, which international implementation.
results in a much larger defect than preoperatively The same relates to late postoperative compli-
described. cations such as chronic pain, ileus, and fistula for-
Certainly, the total defect size is important, but mation. Even the number of recurrences differs ac-
the transverse diameter seems to be more relevant cording to the method of follow-up investigation.
for the intraoperative intention to reach a tension- In the Vypro I trial, the recurrences that occurred
free repair. in Aachen were asymptomatic and detected only
Just recently, prognostic factors such as age, by ultrasound [9]. If the follow-up investigation
gender, consumption of nicotine, obesity, fam- had been done by telephone interview, these recur-
ily history, wound contamination, and previous rences would have never been documented.
postoperative complications have been taken into It remains a comparison of apples with or-
account [6]. Under the aegis of the EHS a new at- anges, a situation that becomes obvious when one
tempt is on its way, but so far, no classification has looks at the only two randomised controlled trials
reached its goal of international implementation. available on incisional hernia repair. In the study
Another problem of comparing the existing of Luijendijk et al., the mesh repair was performed
data is the design of the follow-up period and in a retromuscular way, with a Marlex mesh and
investigation. Knowing that the incidence of in- an overlap of 2 cm. The anterior fascia in front
cisional hernia formation shows a linear rise, the of the mesh was closed only when a tension-free
length of follow-up is of decisive significance. In repair could be achieved; in the other cases, a re-
the study of Luijendijk et al., the rate of recurrence sorbable mesh was interposed, making this study
after incisional hernia formation was 44% after a mixture of mesh augmentation and mesh bridg-
suture repair and 24% after mesh repair [7]. The ing techniques [7]. The other study compared a
follow-up investigation of the same patient popula- large-pore lightweight mesh with three very dif-
tion by Burger et al. several years later revealed an ferent conventional meshes. In this international
increase in recurrence rate with a 10-year cumula- multicentre trial, the importance of a meticulous
tive rate of recurrence of 63% after suture repair protocol can be observed: Crucial steps in the sur-
and 32% after mesh repair [8]. So even many years gical procedure were left to each centre’s standard
after hernia repair, there was still a steady rise in procedure, such as mesh fixation, technique for
recurrence. To evaluate any technique in terms of closing the anterior fascia, and the kind of suture
recurrence, a follow-up of 2 years does not seem to material itself [9].
be sufficient. The available studies and their results are sum-
Evaluation of the clinical results of the differ- marised in ⊡ Tables 30.1–30.3 [10–32]. A compari-
ent repairs must consider early postoperative and son of these clinical results of open mesh repair is
late postoperative complications. Early postopera- possible only with limitations. In open mesh repair,
tive complications include hematoma, seroma, and the retromuscular mesh augmentation seems to
acute postoperative pain. Again, there is no inter- show the best results with the least severe compli-
national consensus on the definition of hematoma cations. A worldwide accepted and applicable clas-
or seroma, detection by ultrasound or clinical in- sification is needed. Also, a differentiation between
vestigation, or size (10 ml or 20 ml)? the different surgical procedures with a subdivi-
Pain is coming more and more into the focus sion into augmentation and bridging techniques
of clinical research. But there is no standardised is urgently necessary. Only then is a comparison
questionnaire being used internationally, so the ex- of clinical results in open incisional hernia repair
isting data cannot really be compared. Infection is possible and reasonable.
230 Chapter 30 · Clinical Results After Open Mesh Repair

⊡ Table 30.1. Results of onlay repair (RCT randomised controlled trial)

Authors Year Study design n Follow-up Compl. Inf. Expl. Rec.


(months) % % %

Vestweber et al. [10] 1997 Retrospective 36 32 ? 27.7 0 6.4

Chevrel [32] 1997 Retrospective 389 1–20 years ? 10.9 0 5.5

Leber et al. [11] 1998 Retrospective 118 80 >20 ? 0 14.8

Rios et al. [12] 2001 Retrospective 246 77 26 17 0 17

Korenkov et al. [ 13] 2002 RCT, stopped 70 14 ? 26 0 8

San Pio et al. [14] 2003 Retrospective 67 68 ? ? ? 15

Machairas et al. [ 15] 2004 Retrospective 43 54 21 ? ? 9

Langer et al. [16] 2005 Retrospective 14 116 32 ? ? 14

Israelsson et al. [17] 2006 Retrospective 281 >12m ? ? ? 19.3

Licheri et al. [18] 2008 Retrospective 64 ? 26.5 ? 0 2/64

Kingsnorth et al. [19] 2008 Prospective 116 15.2 25 8.6 0 3.4

⊡ Table 30.2. Results of retromuscular repair (RCT randomised controlled trial)

Authors Year Study design n follow-up Compl. Inf. Expl. Rec.


30 (months)

Schumpelick et al. [20] 1996 Retrospective 58 54 ? 3.2% 0 7%

McLanahan et al. [21] 1997 Retrospective 106 24 18% 12% 0 3.5%

Ladurner et al. [22] 2001 Retrospective 57 6–33 11% 0 0 2%

Wright et al. [23] 2002 Retrospective 90 32 36% 10% 0 6%

Paajanen and Hermunen [24] 2004 Retrospective 84 36 19% 6% 0 4%

Conze et al. [9] 2005 RCT 165 24 ? 17% 0 12%

Le et al. [25] 2005 Prospective 150 >5 ? 9.3% 2 2%

Israelsson et al. [17] 2006 Retrospective 228 >12 m ? ? ? 7.3%

Kurzer et al. [26] 2008 Retrospective 125 95 ? 1.6% 2 4%

⊡ Table 30.3. Results of open peritoneal onlay mesh repair

Authors Year Study design n Follow-up Compl. Inf. Expl. Rec.


(months)

Marchal et al. [27] 1999 Retrospective 128 48 26% 14% 3 16%

Millikan et al. [28] 2003 Prospective 102 28 6% 0% 0 0%

Heartsill et al. [29] 2005 Retrospective 81 30 >20% 16% 3 15%

Bernard et al. [30] 2007 Prospective 61 35 21% 10% 2 5%

Bingener et al. [31] 2007 Prospective 233 30 15% 6% 6 9%


Chapter 30 · Clinical Results After Open Mesh Repair
231 30
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mesh: clinical and MRI study. Langenbecks Arch Surg
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389:366–370
Arlt G, Langer C, Schippers E, Hartley M, Schumpelick V
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(2005) Randomized clinical trial comparing lightweight
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incisional hernias. Arch Surg 133:378–382
(2003) Intraperitoneal underlay ventral hernia repair utili-
12. Rios A, Rodriguez JM, Munitiz V, Alcaraz P, Pérez D, Par-
zing bilayer expanded polytetrafluoroethylene and poly-
rilla P (2001) Factors that affect recurrence after incisi-
propylene mesh. Am Surg 69:287–291
onal herniorrhaphy with prosthetic material. Eur J Surg
29. Heartsill L, Richards ML, Arfai N, Lee A, Bingener-Casey J,
167:855–859
Schwesinger WH, Sirinek KR (2005) Open Rives-Stoppa
13. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer
ventral hernia repair made simple and successful but not
EA, Troidl H (2002) Randomized clinical trial of suture re-
for everyone. Hernia 9:162–166
pair, polypropylene mesh or autodermal hernioplasty for
30. Bernard C, Polliand C, Mutelica L, Champault G (2007)
incisional hernia. Br J Surg 89:50–56
Repair of giant incisional abdominal wall hernias using
14. San Pio JR, Damsgaard TE, Momsen O, Villadsen I, Larsen
open intraperitoneal mesh. Hernia 11:315–320
J (2003) Repair of giant incisional hernias with polypropy-
31. Bingener J, Buck L, Richards M, Michalek J, Schwesinger
lene mesh: a retrospective study. Scand J Plast Reconstr
W, Sirinek K (2007) Long-term outcomes in laparoscopic
Surg Hand Surg 37:102–106
vs open ventral hernia repair. Arch Surg 142:562–567
15. Machairas A, Misiakos EP, Liakakos T, Karatzas G (2004) In-
32. Chevrel JP, Rath AM (1997) The use of fibrin glues in the
cisional hernioplasty with extraperitoneal onlay polyester
surgical treatment of incisional hernias. Hernia 1:9–14
mesh. Am Surg 70:726–729
16. Langer C, Liersch T, Kley C, Flosman M, Suss M, Siemer A,
Becker H (2005) Twenty-five years of experience in incisi-
232 Chapter 30 · Clinical Results After Open Mesh Repair

Discussion

Bellows: Can you comment on the use of allogenic


mesh material for instance alloderm?
Schumpelick: We have never used biological
meshes. Why should I use such meshes?
Deysine: I totally agree that we need a better clas-
sification of incision hernias.

30
31

Acute and Chronic Pain After


Laparoscopic Incisional Hernia Repair
D. Berger, M. Bientzle
234 Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

Introduction
⊡ Table 31.1. Classification of long-lasting postopera-
tive pain
Laparoscopic repair of incisional hernias is gain-
ing increasing popularity because it has some ad- 0 No pain at all, very satisfied
1 Sometimes minimal pain during work, satisfied
vantages compared to open techniques [1, 2]. The
2 Sometimes moderate pain during work, still satisfied
frequency of infectious complications, for example, 3 Often annoying pain during work, dissatisfied
is significantly reduced. Previous studies also dem- 4 Strong pain at rest, very dissatisfied
onstrated reduced pain after laparoscopic incisional
hernia repair, a finding that has also been pointed
out in a very recent review [3–7]. In contrast, Pierce the mesh, not just the obvious fascial defect. After
et al. clearly showed that early postoperative pain is complete adhesiolysis of the whole abdominal wall,
a major issue [1]. The frequency of prolonged pain the falciform ligament was dissected in cases with
was nearly 2% in the laparoscopic group compared hernias or incisions reaching the upper abdomen.
with 0.9% in the open group. A recent study found In patients with hernias or incisions of the lower ab-
dissatisfying pain in 9% in the long run [8]. domen, the fatty tissue between the plicae mediales
In our preliminary study, all patients who were was dissected to open the Retzius space. The meshes
laparoscopically treated for an incisional hernia were fixed with six stay sutures at the corners and
were followed up in the early postoperative period in the midline in the longest extension of the mesh.
using a visual analogue scale. Long-term follow-up Furthermore, spiral tacks were used every 3–4 cm.
was performed using a pain score similar to those For covering the lower abdomen, the mesh was
used in other studies dealing with chronic pain. fixed with spiral tacks at the pubic bone and the
symphysis. In cases of upper abdominal hernias, the
tacks were placed in the rips at the costal arch.
Patients and Methods Diclofenac and metamizole were routinely
given in the postoperative period. In some cases,
31 Since 2002, all patients treated for incisional her- piritramide was added via a patient-controlled an-
nias have been prospectively followed up in the algesia pump.
early postoperative period with a visual analogue Statistical analysis was done using analysis of
scale ranging from 0 to 10. The patients are studied variance tests for repeated measurements.
twice a day in reclining and upright positions until
leaving the hospital.
Our preliminary evaluation comprised 100 Results
patients. Fifty patients had a mesh derived from
expanded polytetrafluoroethylene (e-PTFE), and As outlined above, the two groups did not differ
starting in May 2004, 50 patients received a mesh concerning demographic or surgical parameters.
derived from polyvinylidene fluoride (PVDF), Dy- As shown in ⊡ Fig. 31.1, the patients suffered from
namesh IPOM. The distribution of age, gender, very strong pain during the first 3 days, espe-
and surgical parameters such as hernia size were cially when in an upright position. The pain scores
not different between the groups. A further clinical slowly decreased from a median of 7 the morning
examination was performed after 1, 3, 6, 12 months of the first postoperative day to 4 and 3 at days 3
and yearly thereafter using a simplified pain score, and 4, respectively.
which is shown in ⊡ Table 31.1. However, there is a significant difference be-
tween the groups: Patients treated with DynaMesh
IPOM showed significantly lower pain scores for 5
Surgical Technique days than patients who received an ePTFE-derived
mesh, as shown by analysis of variance testing for
The surgical technique did not differ over the years. repeated measurements. No further correlation of
Routinely, the whole abdominal scar was covered by pain with other parameters–such as age, gender,
Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair
235 31

⊡ Fig. 31.1. Postoperative visual


analogue scale (VAS) scores. Box
plots are demonstrated. The
2
x-axis shows the time course
between day 1 and day 5, given
as d1m (m morning) to d5e
(e evening). The different time
points differentiate between the
0 reclining (l) and upright patient
positions (s). The y-axis shows the
d1ml d1ms d1el d1es d2ml d2ms d2el d2es d3ml d3ms d3el d3es d4ml d4ms d4el d4es d5ml d5ms d5el d5es VAS level

body mass index, mesh size, hernia size, duration postoperative period, which has been proven for
of the procedure itself, amount and intensity of ad- inguinal hernia repair [9–11]. Our own clinical ex-
hesions, or number of previous procedures–could perience, however, showed that after laparoscopic
be established. incisional hernia repair, the patients suffered from
Chronic pain was observed only during the severe pain. The early literature described a re-
first 3 months of the observation period. The me- duced need for narcotics after laparoscopic repairs
dian pain score after 4 weeks was 1.5, which indi- compared with conventional procedures [3–6].
cates minimal to moderate pain during work. Six Even today, a review of incisional hernia repair
patients were dissatisfied at that time point. Only concluded that laparoscopy is superior compared
one patient was still dissatisfied after 3 months, with open techniques in terms of postoperative
but the problems finally resolved without further pain [7].
treatment. Any correlation of chronic or persisting However, Pierce et al. [1] described in their
pain with clinical parameters could not be estab- analysis that »unlike most other laparoscopic pro-
lished because of the low number of patients. For cedures where incisional pain is typically minimal
the same reason, a differentiation between the two and relatively short lived, laparoscopic incisional
groups did not seem to be appropriate. hernia repair is associated with substantially more
pain in the postoperative period because of the
methods of mesh fixation.«
Discussion Our data clearly show that our patients expe-
rienced annoying pain in the early postoperative
It is usually believed that a main advantage of lap- period. The use of an elastic mesh, the properties
aroscopic procedures is reduced pain in the early of which are comparable to the human abdominal
236 Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

wall [12], is associated with significantly reduced incisional and abdominal wall hernias with mesh. Surg
pain scores. For inguinal hernias, it is known that Endosc 13:250–252
4. Heniford BT, Park A, Park AF, et al. (2003) Laparoscopic
the level of pain in the early postoperative period
repair of ventral hernias: nine years’ experience with 850
strongly correlates with chronic pain problems consecutive hernias. Ann Surg 238:391–400
[13], thus supporting the recommendation that 5. LeBlanc KA, Booth WV, Whitaker JM, Bellanger DE (2001)
elastic meshes should be preferred. A correlation Laparoscopic incisional and ventral herniorraphy: our ini-
between acute and chronic pain could not be es- tial 100 patients. Hernia 5:41–45
6. Park A, Birch DW, Lovrics P (1998) Laparoscopic and open
tablished in our series. The number of patients
incisional hernia repair: a comparison study. Surgery
studied up to now is probably too small. 124:816–821
Some major prospective studies and reviews 7. Misiakos EP, Machairas A, Patapis P, Liakakos T (2008) La-
have observed prolonged or chronic pain in up to paroscopic ventral hernia repair: pros and cons compared
9% of patients [1, 2, 8]. Unfortunately, a definition with open hernia repair. JSLS 12:117–125
8. Stickel M, Rentsch M, Clevert DA, Hernandez-Richter T,
of prolonged pain is not generally given that would
Jauch KW, Lohe F, Angele MK (2007) Laparoscopic mesh
enable comparison among different publications. repair of incisional hernia: an alternative to the conventi-
The prolonged pain is usually explained by the onal open repair? Hernia 11:217–222
fixation devices, mostly transfascial sutures and 9. Bringman S, Ramel S, Heikkinen TJ, Englund T, Westman
tacks [4]. Local anaesthesia is recommended, fol- B, Anderberg B (2003) Tension-free inguinal hernia repair:
TEP versus mesh-plug versus Lichtenstein: a prospective
lowed by removal of stay sutures or tacks in other-
randomized controlled trial. Ann Surg 237:142–147
wise untreatable cases [4]. In one series with 1.6% 10. Collaboration EH (2000) Laparoscopic compared with
persistent pain, the removal of tacks or stay sutures open methods of groin hernia repair: systematic review
did abolish the pain in three of six patients [14]. of randomized controlled trials. Br J Surg 87:860–867
The success rate is not given in any other series. 11. Grant AM (2002) Laparoscopic versus open groin hernia
repair: meta-analysis of randomised trials based on indi-
In our series, chronic pain resolved spontaneously
vidual patient data. Hernia 6:2–10
after conservative treatment in all cases. However, 12. Junge K, Klinge U, Prescher A, Giboni P, Niewiera M,
one patient was significantly restricted in his daily Schumpelick V (2001) Elasticity of the anterior abdominal
31 activities for almost 6 months. wall and impact for reparation of incisional hernias using
In conclusion, laparoscopic repair of incisional mesh implants. Hernia 5:113–118
13. Callesen T, Bech K, Kehlet H (1999) Prospective study of
hernias is a painful treatment needing subsequent
chronic pain after groin hernia repair. Br J Surg 86:1528–
analgesic postoperative therapy. Dynamesh IPOM, 1531
which exhibits a physiological elasticity [12], sig- 14. Wassenaar EB, Raymakers JT, Rakic S (2007) Removal of
nificantly reduces the pain level in the early post- transabdominal sutures for chronic pain after laparosco-
operative period. The number of patients studied pic ventral and incisional hernia repair. Surg Laparosc
Endosc Percutan Tech 17:514–516
does not allow any conclusion about the nature of
chronic pain. An association between acute and
chronic pain could not be established for laparo-
scopic incisional hernia repair. Discussion

Flament: When you report about the hernia size


References you spoke only about the diameter. But there is
still another dimension: The volume of herniated
1. Pierce RA, Spitler JA, Frisella MM, Matthews BD, Brunt
LM (2007) Pooled data analysis of laparoscopic vs. open
bowel. Therefore we do a CT-scan before the op-
ventral hernia repair: 14 years of patient data accrual. Surg eration to measure the volume of the bowel in the
Endosc 21:378–386 abdominal cavity and the volume of the herniated
2. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE (2008) bowel to exactly estimate the size of the hernia.
Minimally invasive ventral herniorrhaphy: an analysis of
Berger: Your approach is very sophisticated and
6,266 published cases. Hernia 12:9–22
3. Carbajo MA, Martin DOJ, Blanco JI, de la Cuesta C, Tole-
would be the best of course.
dano M, Martin F, Vaquero C, Inglada L (1999) Laparosco- Schippers: You use a minimal invasive approach
pic treatment vs open surgery in the solution of major and you use a bridging technique and you have a
Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair
237 31
long period of postoperative pain. What is your
explanation of this pain?
Berger: I can only speculate. I think that a fixation
trough the peritoneum is the main problem.
Chowbey: A secret of good result in laparoscopic
hernia repair depends on the selection of patients.
In what cases laparoscopic hernia repair can be
done and what cases it cannot be done laparoscop-
ically? Another thing is the number of used tackers
for the mesh fixation. If you use too much tackers
the risk of pain raises.
Berger: I agree concerning your remark about
the number of tackers. However, I never found a
recommendation of the number of tackers used
in study dealing with laparoscopic hernia repair.
Of course there are some hernias that cannot be
repaired laparoscopically. If we cannot reach an
adequate overlap – at least five centimeters on both
sites – we do an open procedure.
32

Effect of Nerve Identification on the


Rate of Postoperative Chronic Pain
Following Inguinal Hernia Surgery
S. Alfieri, D. Di Miceli, R. Menghi, G. Quero, C. Cina, G. B. Doglietto
240 Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery

Introduction [2], which is often cited as demonstrating that pain


is not affected by elective division of the ilioinguinal
The ilioinguinal nerve, iliohypogastric nerve, and nerve. However, when reading the whole paper, it is
inguinal segment of the genital branch of the gen- possible to learn that the authors actually performed
itofemoral nerve all cross the inguinal channel and a neurectomy (dividing the nerve lateral to the in-
consequently are vulnerable to injury. ternal ring) instead of a simple division of the nerve
But if they are injured, is there any evidence in the operative field. Consequently, the results of
that they can produce pain syndromes? Should a this paper not only have often been distorted but
suspected injured nerve or a nerve in the way of also may give the erroneous message that the nerves
repair be cut (divided), resected, or left in place? may be sectioned during operation at any level of
Should the cut end of the nerve be left exposed or the inguinal canal without any consequence [3].
buried in the muscle? With the aim of providing uniform terminol-
Much controversy still exists regarding how ogy, the international consensus conference held
to treat these three inguinal nerves during hernia in Rome in April 2008 decided to recommend the
repair, with many published studies showing con- following nomenclature:
trasting results. Consequently, it is right to wonder ▬ Cutting or dividing a nerve means interrupt-
about the following: ing the continuation of a nerve. It is appro-
▬ Do the inguinal nerves really play a role in the priate to mention the way the cut ends were
genesis of postherniorrhaphy inguinodynia handled, such as by ligation, cauterisation, or
and orchialgia? nothing.
▬ Is there any scientific evidence today that ▬ Resection of a nerve or neurectomy means
chronic pain is related to the different treat- removing the segment of a nerve along the
ment reserved for the three inguinal nerves inguinal canal. It is recommended to cut the
during hernia repair? proximal end up to its intramuscular part. It is
appropriate to mention the handling of the cut
In trying to give scientific answers to these ques- ends and the proximal and distal parts of the
tions, we have evaluated not only the levels of evi- section.
32 dence (LE) and grades of recommendation (GR) for
every published study in this field, but we also read
each paper in its entirety and evaluated its statistical Is There Any Correlation Between
validity and the terminology used. It is not surpris- Chronic Pain and Identifying vs. Not
ing that we discovered some discrepancies between Identifying the Three Inguinal Nerves?
the data found in the article and the conclusions
extrapolated by systematic reviews (LE, 1a; GR, A). Although it has been demonstrated that preopera-
tive identification of all inguinal nerves is almost
always possible [4], the majority of surgeons con-
Definitions and Terminology tinue to not detect them, as recently emphasised
and confirmed for the iliohypogastric nerve (de-
An important issue is the need to provide uniform tected in only 32% of cases) and for the genital
terminology to be used in this field. In fact, the branch of the genitofemoral nerve (detected in
terms division, resection, dissection, transection, sec- only 36% of cases) [5].
tion, and neurectomy were often used and reported In fact, the vast majority of the studies report
incorrectly in the literature, which influenced and data for only one nerve (generally the ilioinguinal
distorted the real results of the studies, with im- nerve, probably because is the easiest to recogn-
portant and practical implications involving the ise during hernia repair) without giving any data
treatment of chronic pain [1]. concerning the other two nerves, neglecting the
A clear example of this is demonstrated by the fact that all three nerves contribute to the sensory
wrong interpretation of the study by Picchio et al. innervation of the groin.
Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain
241 32
An Italian prospective multicentre study of domised and apparently have the highest recom-
973 cases and a French single-centre study of mendation grade [3]. These underpowered studies
1,332 cases are the only two published studies are sometimes used in meta-analyses or reviews by
presenting results for all three inguinal nerves calculating a pooled mean percentage by means of
(2,305 cases altogether) with a long follow-up a randomised model to reach some conclusions.
period (1–5 years) [6, 7]. Both studies concluded However, data coming out of such a model that
that identification and preservation of all three uses small studies are completely distorted. Pic-
inguinal nerves (which occurred in 924 patients chio et al. [2] (LE, 1b; GR, A) reported that pain is
considering the two papers together) during open not affected by elective division of the ilioinguinal
inguinal hernia repairs (with or without mesh) nerve. However, by reading the whole paper (with
reduces chronic incapacitating groin pain to less 400 patients in each arm), one discovers that the
than 1%; the mean incidence of chronic pain was author actually performed more of a neurectomy
0.8% (range 0–1.6%). The Italian study also dem- (dividing the nerve lateral to the internal ring) than
onstrated that the risk of developing inguinal pain a simple division of the nerve in the operative field.
increased with the number of nerves concomi- The results of this paper have been often distorted;
tantly undetected. Likewise, the division of nerves in fact, some authors wrongly reported that the
strongly correlated with the presence of chronic nerve was »divided,« and others stated that the
pain [7]. According to the data in the literature, nerve was dissected, without explaining that even if
we can conclude that identifying and protecting Picchio et al. did not report where the nerve was di-
the three inguinal nerves decreases the risk of vided caudally, they divided the nerve lateral to the
postoperative severe chronic pain. internal ring. Merely concluding that division/dis-
section of the ilioinguinal nerve does not increase
or reduce the risk of chronic pain not only distorts
Should the Identified Nerve Be the researchers’ results, but, more importantly, it
Preserved, Divided, or Resected may give the erroneous message that the nerves
(Neurectomy)? may be sectioned during operation at any level of
the inguinal canal without any consequence.
All of the published studies report data concern- Picchio et al. [2] (LE, 1b; GR, A) report that pain
ing division versus preservation of only a single is not affected by elective neurectomy (according to
nerve, without giving any data concerning the the new nomenclature of the consensus conference)
other two nerves. In all of these papers, the of the ilioinguinal nerve, and Pappalardo et al. [12]
results are distorted because the nerves not con- report this for iliohypogastric neurectomy.
sidered could have been unintentionally divided According to the literature, we can conclude
or injured during operation. For these reasons, that identification and protection of all three
chronic pain could be generated [8]. The stud- nerves during open inguinal hernia repair (with
ies by Ravichandran et al. [9] (LE, 2b; GR, B) or without mesh) reduces the risk of chronic inca-
and Mui et al. [10] (LE, 1b; GR, A) report results pacitating pain to less than 1%.
of preservation versus neurectomy of only one
single nerve, and these results are also limited
by very small sample sizes, with only 20 patients Should the Identified Nerve Be
and 50 patients in each arm. Therefore, these Isolated or Left in its Natural Bed
studies do not have substantial statistical power Without Manipulation, Taking Care
compared with the study of Dittrik et al. [11] (LE, To Not Remove the Covering Fascia
2b; GR, B), which also did not have homogeneous of the Nerve?
distribution between the two arms (66 patients
versus 24 patients). No published data are available regarding ma-
In these cases, no conclusions can be evalu- nipulation versus no manipulation of a preserved
ated, even if some studies are prospective and ran- nerve. However, considering the anatomical stud-
242 Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery

ies [4], we suggest (LE, 5; GR, D) leaving the the tal branch nerve can be damaged if inadvertently
nerves in their natural bed as much as possible and sectioned, entrapped, or secured (for example, if a
not removing the covering fascia. continuous suture is introduced along the inguinal
ligament), or it can be injured if the external sper-
matic vessels are divided to skeletonise the cord
Should a Suspected Injured Nerve or without its identification.
a Nerve in the Way of Repair Be Saved
by All Means or Resected?
Should the Cremasteric Layer Be Saved
The current literature is inconsistent concerning or Resected?
this point. Opinions differ considerably, but no
published data are actually available. No published data are available in the literature.
Some authors emphasise that when an injury However, it is advisable for hernia mesh repair
has occurred, the intramuscular portion of the to save the cremasteric layer to reduce the risk
nerve must be resected, stating that merely di- of ilioinguinal and genital branch nerve damage
viding the nerve at the point of its emergence is and thus avoid possible incapacitating and chronic
inadequate [3, 5]. These data are supported by postoperative pain (LE, 5; GR, D).
the increasing success rates of pain relief with
extended versus standard neurectomy procedures,
as obtained by Amid et al. [5] for patients with Should the Cut Ends of the Nerve Be
chronic postherniorrhaphy pain (LE, 4; GR, C) Left Alone, Ligated, or Cauterised?
and by Alfieri et al. [6], who reported that the
increased risk of developing chronic pain with the No scientific data are reported in the literature
number of nerves divided could be explained by concerning the treatment of the cut ends of the
the fact that resection of the unidentified nerve nerves.
has generally been performed distal to its origin;
this leaves the site of the injured nerve intact–and
When Glue Is Used, Should We Still
32 able to continue to generate a pain signal–and ex-
Identify and Protect the Nerves?
poses it to neuroma formation (LE, 5; GR, D). At
the same time, there is no scientific evidence that
the cut end of the nerve should be left exposed or No data are present in the literature concerning
buried in the muscle. While we await definitive whether nerves should be identified and protected
results in the literature, it is reasonable to remove even if glue is used. However, it is reasonable to
a suspected injured nerve or a nerve in the way of consider that nerves should be identified and pro-
the repair during any type of repair and to implant tected in any case (LE, 5; GR, D).
the proximal cut end in the muscle (LE, 5; GR, D).

Is There Convincing Evidence that


How Can the Inguinal Segment of the Prophylactic Division or Resection
Genital Branch of the Genitofemoral of Nerves During Hernia Repair Will
Nerve Be Identified and Protected Reduce the Rate of Chronic Pain?
During the Open Procedure?
Three randomised trials examined the effect of
Identifying and protecting the inguinal segment prophylactic neurectomy on chronic pain [2, 9,
of the genital branch nerve during hernia repair 10]. In all of the trials, the ilioinguinal nerve was
is not difficult. It can be recognised, identifying either divided or partially resected and the pa-
and keeping the external spermatic vein (the so- tients assessed for pain, numbness, and touch and
called blue line) with the cord. However, the geni- pain sensation at 1, 6, and 12 months. None of the
Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain
243 32
studies found differences in pain or numbness, al- preserve the 3 inguinal nerves during hernia repair? Ann
though one found significant improvements in ac- Surg 2008; 247(6)
4. Wijsmuller, A.R., et al. Nerve-identifying inguinal hernia
tivities such as cycling and walking in favour of the
repair: a surgical anatomical study. World J Surg 2007;
nerve division group. In a prospective multicentre 31(2):414–420; discussion 421–422
study of 973 patients undergoing inguinal hernia 5. Amid P.K., Hiatt J.R. New understanding of the causes and
repair in which all nerves were identified [6], surgical treatment of postherniorrhaphy inguinodynia
nerve division was associated with an increased and orchialgia. J Am Coll Surg 2007; 205(2):381–385
6. Alfieri S., Rotondi F., Di GiorgioA., Fumagalli U., Salzano A.,
risk of moderate to severe pain.
Di Miceli D., Ridolfini M.P., Sgagari A., Doglietto G.B., Groin
According to the published results in the lit- Pain Trial Group. Influence of preservation versus division
erature, we can conclude that there is no evidence of ilioinguinal, iliohypogastric, and genital nerves du-
that prophylactic neurectomy reduces chronic pain ring open mesh herniorrhaphy: prospective multicentric
after inguinal hernia repair. On the contrary, indi- study of chronic pain. Ann Surg 2006; 243(4):553–558
7. Izard G., Gailleton R., Randrianasolo S., Houry R. Treatment
rect evidence suggests that identification and pres-
of inguinal hernias by McVay’s technique in a series of
ervation of all nerves may be beneficial. However, 1332 cases. Ann Chir 1996; 50(9):755–756
further studies addressing this issue are required. 8. Alfieri S., Di Miceli D., Doglietto G.B. Prophylactic ilioingu-
inal neurectomy in open inguinal hernia repair. Ann Surg
2007; 245(4):663
Conclusions 9. Ravichandran D., Kalambe B.G., Pain J.A. Pilot randomized
controlled study of preservation or division of ilioinguinal
nerve in open mesh repair of inguinal hernia. Br J Surg
The data would suggest that if one or more nerves 2000; 87(9):1166–1167
is not detected during surgery, it is possible that 10. Mui W.L., Ng C.S., Fung T.M., Cheung F.K., Wong C.M., Ma
they could be inadvertently sectioned, entrapped, T.H., Bn M.Y., Ng E.K. Prophylactic ilioinguinal neurectomy
in open ilioinguinal repair: a double-blind randomized
or secured (for example, if a continuous suture is
controlled trial. Ann Surg 2006; 244(1):27–33
introduced along the inguinal ligament), or they 11. Dittrick G.W., Ridl K., Kuhn J.A., McCarty T.M. Routine ilioin-
could be injured (such as if the external spermatic guinal nerve excision in inguinal hernia repairs. Am J Surg
vessels are divided to skeletonise the cord). 2004; 188(6):736–740
It should not be forgotten that nerves are most 12. Pappalardo G., Frattaroli F.M., Mongardini M., Salvi P.F.,
Lombradi A., Conte A.M., Arezzo M.F. Neurectomy to
often injured when the surgeon is unaware of their
prevent persistent pain after inguinal herniorrhaphy: a
location and course, or when he or she fails to prospective study using objective criteria to assess pain.
recognise them during surgery. Caution is stressed World J Surg 2007; 31(5):1081–1086
when teaching this common procedure to resident
physicians.
Finally, it is very important to develop a uni-
form terminology for this field in order to better Discussion
analyse and compare the studies and thereby avoid
giving wrong messages to the community. Amid: To present the results of the consensus con-
ference in ten minutes is not enough time.
Schippers: One of your recommendations was to
References leave the nerve where it was. You recommend not
touching the nerve anyway. But with this recom-
1. Alfieri S., Di Miceli D., Doglietto G.B. Re: nerve manage- mendation you have problems to do the Shouldice
ment during open hernia repair Br J Surg 2007; 94(7):914 repair properly.
2. Picchio M., Palimento D., Attanasio U., Matarazzo P.F., Alfieri: But this is just a personal comment and the
Bambini C., Caliendo A. Randomized controlled trial of evidence level is very low.
preservation or elective division of ilioinguinal nerve on
open inguinal hernia repair with polypropylene mesh.
Arch Surg 2004; 139(7):755–758
3. Alfieri S. Is there a consensus concerning the relationship
between post-operative chronic pain and treatment to
33

Discomfort 5 Years After Laparoscopic


and Shouldice Inguinal Hernia Repair:
A Report from the SMIL Study Group
A. Montgomery
246 Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

Introduction drop-outs for the long-term follow-up. The method


of follow-up is also important. A clinical examina-
Hernia recurrence used to be the main outcome tion and a standardised protocol are seldom used.
measurement when reporting on the results of Several large randomised studies comparing
inguinal hernia surgery. Today the problem of re- laparoscopic to open repair for primary unilateral
currence is limited as a result of standardised mesh inguinal hernias with a long follow-up have been
techniques. A recurrence does not always result in performed, with a primary end point of recurrence
a problem for the patient, and if it does, it can usu- rate. Most of these studies were initiated during the
ally be resolved after a new repair. 1990s. Chronic pain is reported as a secondary end
Chronic pain and discomfort is considered to point [12–15]. The SMIL study group described
be the most important outcome measure of inguinal below has reported on some large randomised
hernia repair. Chronic pain and discomfort are often studies. This chapter mainly concentrates on the
difficult to handle, and even small constant prob- discussion of chronic pain and discomfort from
lems can be an annoying reminder to the patient of the first study–SMIL I.
the former hernia. This is why the indications for
surgery must be very strict. The study on »watch-
ful waiting« in patients with very mild symptoms is SMIL Study Group
therefore of great importance in this respect [1].
Chronic pain is commonly defined as pain or The Swedish Multicentre Trial of Inguinal Hernia
discomfort that lasts for more than 3 months post- Repair by Laparoscopy study group (SMIL for
operatively. The incidence of chronic pain varies short) was formed in 1993 to evaluate the possible
widely in different publications: between 0% and benefit of laparoscopic repair compared with open
75% in open mesh repair and between 0% and 29% techniques. The aim was to conduct well-designed
after laparoscopic hernia repair [2–4]. Most of the large multicentre randomised controlled trials
problems are described as mild discomfort. Pain within general surgeon practices in the normal
affecting daily activities has been reported to be as clinical setting. The group has conducted two large
high as 5–6% [5, 6]. Some authors claim that mesh studies comparing laparoscopic and open repair.
repair results in less chronic pain than nonmesh SMIL I started in 1993 and compares transabdom-
repair and that laparoscopic repair is more favour- inal preperitoneal (TAPP) repair with Shouldice
able than open mesh repair in this regard [7–9]. repair for primary inguinal hernias. This study has
33 The lack of description and definition of pos- resulted in three publications [16–18].
therniorrhaphy pain and discomfort is a problem, SMIL II was the second large study, initiated
making it impossible to compare the results from in 1996 as a result of the development of both the
different studies. Professor Kehlet from Denmark laparoscopic and the open inguinal hernia repair
and his colleagues have called for »uniform as- techniques. At that time, the totally extraperitoneal
sessment on postherniorrhaphy pain« to facilitate (TEP) technique had been introduced, avoiding
interpretation of further studies [10]. Such as- the transabdominal approach. At the same time,
sessment is complicated, though, and must take larger meshes were recommended for a larger
many aspects into account. Fränneby et al. have at- overlap of the hernial orifices, with the aim of re-
tempted this by constructing an 18-question form, ducing the risk of a recurrence. In this study, TEP
a specific inguinal pain questionnaire called the was compared with the open mesh technique of
IPQ, which has been validated [11]. Lichtenstein, which was the gold standard at that
Another problem is that the patients who are time. This study has resulted in two publications,
included in different studies often show a mixture of and another two have been submitted [19, 20].
different techniques for both open and laparoscopic The third study is an early study of the use of
repair and for primary and recurrent hernias, and small meshes in the laparoscopic group, compar-
there are variations in the length of follow-up. An ing TAPP with Lichtenstein for recurrent hernias.
additional complication is the number of patient This has resulted in one publication [21].
Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair
247 33
All three studies were designed with a primary nique from seven different hospitals participated
end point of recurrence after 5 years. in the study. Both preoperative and perioperative
variables were recorded, and short-term outcomes
regarding pain were recorded on a visual analogue
TAPP vs. Shouldice–SMIL I scale (VAS) daily during the first week. The patient’s
functional status was also recorded. A clinical exam
The TAPP technique was compared to the open was performed at 1 and 5 years postoperatively, look-
Shouldice operation in primary inguinal hernias in ing for recurrences and complaints, and a written
male patients between 30 and 70 years of age. A to- questionnaire was answered at 1, 2, 3, and 5 years.
tal of 25 board-certified surgeons using either tech- The patient was asked to describe his experience of
any discomfort after the operation according to the
form depicted in ⊡ Fig. 33.1. In cases of suspected
Have you noticed signs of recurrence of your hernia recurrence or severe complaints, the patient was ex-
(a bulge in the operated groin)? amined clinically. Complaints were graded accord-
Yes No ing to the definitions of discomfort described in
⊡ Fig. 33.2. Two independent and blinded observers
Do you have any other complaints?
performed the grading. A consensus discussion was
Yes No held when opinions differed.

If yes, describe them here.


Results

A total of 1,068 patients were operated on within


the study. Patient characteristics were similar in
the two groups. A total of 867 patients (81.2%)
were eligible for analysis after 5 years. Levels of
⊡ Fig. 33.1. Form used by the patient to describe complaints
discomfort and pain in the two groups at the dif-
after inguinal hernia surgery
ferent time points are reported in ⊡ Table 33.1. The
total percentage of patients who experienced dis-
Mild: Occasional discomfort or pain that comfort of any kind was 8.5% in the TAPP group
does not interfere with daily life and 11.4% in the Shouldice group, with no sig-
Moderate: Occasional discomfort or pain that nificant difference between the groups. Although
interferes with daily life discomfort was usually mild, it was severe in 0.2%
Severe: Daily discomfort and pain that of the laparoscopic group and 0.7% of the open re-
interferes with daily life pair group. Severe pain the first postoperative week
was the only risk factor for late discomfort in the
⊡ Fig. 33.2. Definitions of discomfort Shouldice group [odds ratio (OR) 2.25, P=0.022].

⊡ Table 33.1. Grade of discomfort at different time points in the SMIL I study (TAPP transabdominal preperitoneal)

1 Year 2 years 3 years 5 years


Tapp Open Tapp Open Tapp Open Tapp Open
Mild 9.4 10.5 8.9 13.4 9.2 10.6 5.5 7.9
Moderate 3.1 3.4 2.2 2.8 2.3 3.8 2.8 2.8
Severe 0.2 0 0 0.2 0 0 0.2 0.7
Total 12.7 13.9 11.2 16.4 11.5 14.4 8.5 11.4
248 Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

No other risk factor for late discomfort was found The number of patients classified as having
in either group. severe pain was low in both groups. Patients with
severe or moderate pain were therefore merged,
creating the moderate/severe pain group. The re-
Discomfort in SMIL I Compared with sults are demonstrated in ⊡ Fig. 33.4. There was
SMIL II a statistically significant trend over time for a
decrease in frequency of moderate/severe chronic
The SMIL II study had the same protocol as SMIL pain for Lichtenstein repair but not for the other
I, but the operating techniques were different, as techniques.
described above. A total of 1,370 patients were op- In a multivariable analysis, risk factors for
erated on, and 1,275 had a 5-year follow-up. Having chronic pain in the TEP group were impairment
the same protocol enables more appropriate com- in the physical test after 1 week, longer recovery
parison of all four techniques regarding postopera- time than the median, and weight below the 3rd
tive pain. Discomfort at 1, 2, 3, and 5 years is shown quartile. For the Lichtenstein group, the risk factor
in ⊡ Fig. 33.3. There was a statistically difference was pronounced postoperative pain.
between Shouldice and TAPP only at the 2-year
point. There was a statistically significant difference
between Lichtenstein and TEP at all time points Discussion
in favour of the TEP technique. The risk of having
chronic pain was approximately twice as high in Discomfort and chronic pain was not the primary
the Lichtenstein group as in the other groups at all end point in any of the large randomised studies
time points; almost 20% in the Lichtenstein group comparing laparoscopic and open hernia inguinal
reported discomfort at all time points. hernia repair. Altogether, there are four studies on

%
* * *
20 *
33 18 *
16
14
12 TAPP
Shouldice
10
TEP
8 Lichtenstein
6
4
2
0
1 2 3 5 years

⊡ Fig. 33.3. Total amount of discomfort for different techniques at different time points in the SMIL I and II studies. Significant
differences between groups are indicated by an asterisk (*)
Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair
249 33
chronic pain besides the SMIL studies, including procedures. The same mesh was used for the Lich-
more than 400 patients [12–15]. There are huge dif- tenstein operation. In recent research, anchoring
ferences in these studies in follow-up time, which of the mesh has been discussed as one cause of
varies between 1 and 5 years. There are also huge chronic pain. Several randomised studies have
differences in the percentage of attendees at the last been performed on different fixation techniques,
follow-up, varying between 61% and 96%. The defi- showing advantages for the nonfixated or glued
nition of chronic pain is also difficult to compare mesh in endoscopic methods [22–25]. The advan-
among the studies, but all studies report less pain tage of less pain by using a low-weight mesh with
with the laparoscopic technique. However, this var- large pores has also been discussed [26, 26].
ies in the studies, too, being between 0% and 18% All in all, the endoscopic preperitoneal tech-
for the laparoscopic technique and between 1% and nique seems to be more favourable for patients from
20% for the open techniques. The overall percentage the aspect of preventing chronic pain and discom-
of chronic pain at 5 years in the SMIL I study was fort. Development of new meshes and avoidance of
8.5% for TAPP and 11.4% for Shouldice. This dif- fixation might favour the patients even further.
ference is, however, not significant. In SMIL II there
was a bigger difference between chronic pain in
the TEP-operated and Lichtenstein groups–9% and References
19%, respectively. However, the high attendance,
with clinical examination and a standardised ques- 1. Fitzgibbons RJ, Giobbie-Hurder A et al. (2006) Watchful
waiting vs repair of inguinal hernia in minimally symp-
tionnaire, at 5-year follow-up in both SMIL studies
tomatic men. A randomized clinical trial. JAMA 295:285–
is one of the SMIL studies’ strengths. 292
A heavy polypropylene mesh was fixated us- 2. Nienhuijs SW, van Oort I, Keemers-Gels ME, Strobbe LJA,
ing a stapling device in both the TAPP and TEP Rosman C. (2005) Randomized clinical trial comparing

%
20
18
16
14
12 TAPP
Shouldice
10
* TEP
8 Lichtenstein
6 *
4
2
0
1 2 3 5 years

⊡ Fig. 33.4. Moderate or severe discomfort for different techniques at different time points in the SMIL I and II studies. Signifi-
cant differences between groups are indicated by an asterisk (*)
250 Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

the Prolene Hernia System, mesh plug repair and Lich- 16. Berndsen F, Arvidsson D, Enander L-K, Leijonmarck CE,
tenstein method for open inguinal hernia repair. Br J Surg Wingren U, Rudberg C, Smedberg S, Wickbom G, Montgo-
92:33–38 mery A. (2002) Postoperative convalescence after ingui-
3. Poolban AS, Bruce J, Smith WC, King PM, Krukowski ZH, nal hernia surgery: prospective randomised multicenter
Chambers WA. (2003) A review of chronic pain after ingui- study of laparoscopic versus Shouldice inguinal hernia
nal herniorrhaphy. Clin J Pain 19(1):48–54 repair in 1042 patients. Hernia 6:56–61
4. PageB, Paterson C, Young D, O´Dwyer PJ. (2002) Pain from 17. Arvidsson D, Berndsen FH, Larsson LG, Leijonmarck CE,
primary inguinal hernia and the effect of repair on pain. Rimback G, Rudberg C, Smedberg S, Spangen L, Montgo-
Br J Surg 89(10):1315–1318 mery A. (2005) Randomized clinical trial comparing 5-year
5. Kalliomäki ML, Sandblom G, Gunnarsson U, Gordh T. recurrence rate after laparoscopic versus Shouldice repair
(2009) Persistent pain after groin hernia surgery: a quali- of primary inguinal hernia. Br J Surg 92:1085–1091
tative analysis of pain and its consequences for quality of 18. Berndsen F, Petersson U, Arvidsson D, Leijonmarck C, Rud-
life. Acta Anaesthesiol Scand 53(2):236-246 berg C, Smedberg S, Montgomery A. (2007) Discomfort
6. Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson five years after laparoscopic and Shouldice inguinal her-
U. (2006) Risk factors for long-term pain after hernia sur- nia repair: a randomised trial with 867 patients. A report
gery. Ann Surg 244(2):212–219 from the SMIL study group. Hernia 11(4):307–313
7. Schmedt C-G, Sauerland S, Bittner R. (2005) Compari- 19. Ekelund A, Rudberg C, Smedberg S, Enander LK, Leijon-
son of endoscopic procedures vs Lichtenstein and other marck CE, Österberg J and Montgomery A. (2006) Short-
open mesh techniques for inguinal hernia repair. A me- term results of a randomized clinical trial comparing
ta-analysis of randomized controlled trials. Surg Endosc Lichtenstein open repair with totally extraperitoneal lapa-
19:188–199 roscopic inguinal hernia repair. Br J Surg 93:1060–1068
8. Bittner R, Sauerland S, Schmedt C-G. (2005) Comparison 20. Eklund A, Montgomery A, Rasmussen I, Sandbue R, Bergk-
of endoscopic techniques vs Shouldice and other open vist L, Rudberg C. (2009) Low recurrence rate after lapa-
nonmesh techniques for inguinal hernia repair. A meta- roscopic (TEP) and open (Lichtenstein) inguinal hernia
analysis of randomized controlled trials. Surg Endosc repair. Ann Surg 249(1):33–38
19:605–615 21. Eklund A, Rudberg C, Leijonmarck CE, Rasmussen I, Span-
9. McCormack K, Scott NW, Go PM, Ross S, Grant AM and gen L, Wickbom G, Wingren U, Montgomery A. (2007)
the EU Hernia Trialists Collaboration. (2003) Laparoscopic Recurrent inguinal hernia: randomized multicenter trial
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repair. Cochrane Database Syst Rev (1)CD001785 dosc 21:634–640
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postherniorrhaphy pain–a call for uniform assessment. (2008) Laparoscopic inguinal hernia repair without mesh
Hernia 6:178–181 fixation: early results of a large randomised clinical trial.
11. Fränneby U, Gunnarsson U, Andersson U, Heuman R, Surg Endosc 22(3):757–762
Nordin P, Nyrén O, Sandblom G. (2008) Validation of an 23. Olmi S, Scaini A, Erba L, Guaglio M, Groce E. (2007) Quan-
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33 pain after groin hernia repair. Br J Surg 95(4):488–493 ritoneal (TAPP) inguinal hernioplasty identifies marked
12. Grant AM, Scott NW, O´Dwyer PJ, on behalf of the MRC differences between prosthesis fixation systems. Surgery
Laparoscopic Groin Hernia Trial Group. (2004) Five- 142(1): 40–46
year follow-up of a randomized trial to assess pain and 24. Lovisetto F, Zonta S, Rota E, Mazzilli M, Bardone M, Bottero
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RU, Clevers GJ, Meijer WS, Stassen LP, Vente JP, Weidema tive, randomized study. Ann Surg 245(2):222–231
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15. Neumayer L, Giobbe-Hurder A, Jonasson O, Fitzgibbons R V. (2002) Functional and morphologic properties of a
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1827
34

Recurrence or Complication:
The Lesser of Two Evils? A Review
of Patient-Reported Outcomes
from the VA Hernia Trial
L. Neumayer
252 Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?

Introduction comes Study Short Form 36 (SF-36). This analysis


was limited to patients who had both preoperative
Inguinal hernia is one of the most common disease and postoperative PRO assessment. Cumulative
states affecting men worldwide. The direct and rates of recurrence and complications were used.
indirect costs of this condition, with or without re- Complications were further divided into four cat-
pair, are great. Recent studies have questioned the egories: (1) hematoma/seroma, (2) orchitis, (3)
need for repair in asymptomatic patients; however, neuralgia of the leg or groin, and (4) other. Patient-
in both of these studies, pain and discomfort were reported outcomes included the SF-36, the SPS,
the main reasons for a crossover to repair from the the AAS, and patient satisfaction. All of these out-
»watchful waiting« group [1, 2]. comes were measured at baseline and at 2 weeks,
Pain is now recognized as a common com- 3 months, 6 months, and 1 and 2 years postop-
plication after hernia repair. In this review we eratively. (Patient satisfaction, however, was not
intend to address, using previously reported data measured at 2 years.)
[3–5], the issue of whether a recurrence–which is To evaluate the relationships between preop-
viewed by most surgeons as a negative outcome–is erative and postoperative PROs, we used Pearson’s
worse for the patient in the long term than pain correlation coefficients. Univariate comparisons
or other complications. Further, we review pre- among groups were performed using analysis of
dictors of complications that may help guide sur- variance for continuous variables and chi-square
geons in the choice of operation for individual or Fisher’s exact test for categorical variables. Re-
patients. gression analyses were employed to determine sig-
nificant predictors of postoperative PROs.
As previously reported, we further analyzed
Methods predictors of short-term and long-term complica-
tions and long-term pain by initially looking for
The methods of the U.S. Department of Veteran potential predictors with appropriate univariate
Affairs (VA) hernia trial comparing laparoscopic statistics. Our initial analyses revealed different
versus open tension free hernia repair, as well as predictors for open and laparoscopic techniques,
the analyses performed for evaluation of patient- so we modeled these separately. Only outcomes
reported outcomes and predictors of complica- with at least 50 occurrences and with p-values >0.2
tions, have been previously reported [3–6]. The in univariate comparisons were entered into re-
study was designed to detect a 3% difference in re- gression models to ensure relative stability in the
currence at 3 years and to evaluate other surgeon- models [5].
34 centered and patient-centered outcomes (com-
plications/death, pain, functional status, activity
levels, caregiver burden, and cost). In addition, we Results
measured patient and surgeon satisfaction. As part
of this large study, two new instruments, the Surgi- As reported previously 2,134 men were random-
cal Pain Scale (SPS) and the Activities Assessment ized to Lichtenstein or laparoscopic (totally ex-
Scale (AAS), were developed and validated [7, 8]. traperitoneal or transabdominal preperitoneal)
All results reported herein have been previously repair of their inguinal hernias [3]. Although a
reported [3–6]. This report serves as an amalga- few patients did not undergo repair, 1,983 com-
mation of prior analyses. pleted an operative intervention, and 1,696 were
As a post hoc analysis, we also evaluated the available for 2-year recurrence assessment. Nearly
relationship between patient-reported outcomes all of these patients (1,603) also had PRO data at
(PROs) and recurrence or complications [4]. In 2 years (1,526 had PRO data at 1 year). Demo-
particular, we sought to determine the impact of graphics of the patients with PRO data at 1 and
recurrence and other complications on overall pa- 2 years were similar to those of the whole group
tient outcome as measured by the Medical Out- (⊡ Table 34.1) [3, 4].
Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?
253 34

⊡ Table 34.1. Demographic and outcome data, adapted from Hawn et al. [5] and Matthews et al. [6] (PRO patient-
reported outcome)

Total study PRO subgroup at 2 years


N=1,983 N=1,603

Open Laparoscopic Open Laparoscopic


N (%) N (%) N (%) N (%)

Recurrence 41/834 (4.9) 87/862 (10.1) 37 (4.6) 68 (8.5)

Neuralgia 99/950 (10.4) 71/943 (7.5) 67 (8.4) 53 (6.6)

Hematoma 17/950 (1.8) 50/943 (5.3) 14 (1.8) 41 (5.1)

Orchitis 7/950 (0.7) 11/943 (1.2) 6 (0.8) 11 (1.4)

Other 80/950 (8.4) 86/943 (9.1) 69 (8.6) 81 (10.1)

Patients with recurrence, a complication, Younger patients who were not actively em-
or both reported scores for the AAS, SPS, and ployed prior to operation reported more limita-
physical component portion of the SF-36 that tions in activity during work or exercise as mea-
were significantly different on univariate analy- sured by the AAS. The presence of neuralgia,
ses (p<0.001) from those for patients without a orchitis, or other complications also limited activ-
recurrence or complication. Patient satisfaction ity during work or exercise, but the presence of a
also differed; 97% of patients who did not have recurrence did not limit activity during work or
a recurrence or complication were satisfied with exercise. When operative techniques were com-
their operation, whereas only 62% of those with a pared, other complications after laparoscopic re-
recurrence and 89% of those with a complication pair were accompanied by limitations in patient
were satisfied. activity, whereas other complications after open
After adjustments were made for baseline pre- repair did not seem to limit activity.
operative scores and patient demographics, a re- Younger patients and those with a recurrence,
currence did not affect the patient’s general health neuralgia, or other complications were signifi-
status as measured by the SF-36. However, patients cantly less likely to be satisfied with the operation
with neuralgia or orchitis had significantly lower or their total hernia care when analyzed by logistic
PCS scores than patients who did not suffer those regression.
complications. Patients with neuralgia had lower
mental component scores than those without neu-
ralgia. Predictors of Complications
After open repair, patients with a recurrence
had significantly more pain at rest and with activ- As previously reported, complications were di-
ity than patients who had recurrence after laparo- vided into short term (occurring within 2 weeks of
scopic repair. As would be expected, patients with operation) and long term (occurring at 3 months
self-reported neuralgia had higher pain scores on and beyond) and occurred more frequently in
the SPS (10-mm difference at rest, 21-mm dif- patients who had undergone laparoscopic repair
ference during work or exercise) compared with (39% vs. 33%, p=0.02) [3, 5]. The most com-
patients without neuralgia. Younger patients had mon short-term complications in both the open
more pain preoperatively and postoperatively than and laparoscopic groups were wounds/scrotal
older patients did, but the magnitudes of reduction hematomas/seromas and urinary retention. The
in pain scores were equivalent between younger most common long-term complications were
and older patients. seromas and chronic leg or groin pain. Wound
254 Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?

⊡ Table 34.2. Predictors of complications after open repair (multivariate analysis), adapted from Matthews et al. [6] (OR
odds ratio; CI confidence interval; MCS mental component score)

Complications Significant predictors Adjusted OR p-value


(c-index of model) (95% CI)

Short-term Type of hernia: recurrent 2.02 0.006


(0.655) (1.22, 3.32)

Hispanic ethnicity 2.94 0.043


(1.03, 8.35)

Hernia into scrotum 2.31 0.0005


(1.47, 3.94)

Long-term SF-36 MCS score: OR for each 3-unit increase 0.95 0.008
(0.624) (0.92, 0.99)

Age: OR for each 5-year increase 0.90 0.003


(0.84, 0.97)

⊡ Table 34.3. Predictors of complications after laparoscopic repair (multivariate analysis), adapted from Matthews et al.
[6] (OR odds ratio; CI confidence interval; BMI body mass index)

Complications Significant predictors Adjusted OR p-value


(c-index of model) (95% CI)

Short-term Enlargement of hernia in past 6 months 1.50 0.01


(0.644) (1.10, 2.05)

Duration: present for >1 year 1.59 0.004


(1.16, 2.18)

Hernia into scrotum 2.02 0.011


(1.18, 3.46)

Prostatism 1.94 0.0005


(1.34, 2.81)

Type of hernia: recurrent 2.04 0.003


34 (1.27, 3.27)

Long-term Prostatism 1.71 0.009


(0.631) (1.14, 2.57)

BMI: OR for each 1-unit BMI increase 1.07 0.006


(1.02, 1.12)

infection was infrequent at any time for both long-term complications in the laparoscopic group,
types of repair, and no patient required mesh while younger age was associated with long-term
removal. complications in the open group. Younger age was
For both techniques, having a recurrent hernia associated with a higher likelihood of long-term
repaired increased the likelihood of short-term pain in both open and laparoscopic groups (the
complications, as did the presence of a hernia ex- adjusted odds ratio for each 5-year increase in age
tending into the scrotum (⊡ Tables 34.2 and 34.3). was 0.82 in open repairs and 0.83 in laparoscopic
Prostatism was a predictor for both short-term and repairs) [5].
Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?
255 34
Discussion tients needing inguinal hernia repair are not »good
risk,« thus limiting to some extent the generaliz-
The VA hernia trial comparing laparoscopic and ability of our results.
open tension-free inguinal hernia repair in men is
one of the largest ever conducted. We planned to
be able to examine both surgeon-centered (recur- References
rence, complications, and death) and patient-cen-
tered (SF-36 functional status, surgical pain, activi- 1. Fitzgibbons RJ, Giobbie-Hurder A, Gibbs JO, Dunlop DD,
Reda DJ, McCarthy M, Neumayer LA, et al. (2006) Watch-
ties) outcomes for the duration of the study, which
ful waiting vs repair of inguinal hernia in minimally
included a minimum of 2 years of follow-up. Col- symptomatic men: a randomized clinical trial. JAMA
lecting such massive amounts of data has allowed 295(3):285–292
analyses of many different outcomes. Our analysis 2. O’Dwyer PJ, Norrie J, Alani A, et al. (2006) Observation
of the relationship of patient-centered outcomes or operation for patients with an asymptomatic inguinal
hernia. A randomized clinical trial. Ann Surg 244(2):
to recurrences and complications is one of the few
167–173
based on prospectively collected data rather than 3. Neumayer L, Jonasson O, Fitzgibbons R, Henderson W,
recall data from patients mailed a survey years af- Gibbs J, Carrico CJ, Itani K, Kim L, Pappas T, Reda D, Dun-
ter their herniorrhaphy. lop D, McCarthy, Hynes D, Giobbie-Hurder A, London MJ,
From these further analyses, we have con- Hatton-Ward S. (2003) Tension-free inguinal hernia repair:
the design of a trial to compare open and laparoscopic
firmed the findings of others that chronic pain
surgical techniques. J Am Coll Surg 196(5):743–752
is a significant and measurable adverse effect of 4. Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons
hernia repair and that it is more common long R, Dunlop D, Gibbs J, Reda D, Henderson W. (2004) Open
term after open repairs and in younger patients. mesh versus laparoscopic mesh repair of inguinal hernia.
We have further elucidated that for most patients, N Engl J Med 350(18):1819–1827
5. Hawn MT, Itani K, Giobbie-Hurder A, McCarthy M, Jonas-
chronic pain has a deleterious effect on overall
son O, Neumayer LA. (2006) Patient reported outcomes
functional status, whereas recurrence, although following inguinal herniorrhaphy. Surgery 140:198–205
associated with pain, in and of itself does not 6. Matthews RM, Anthony T, Kim LT, Wang J, Fitzgibbons
negatively affect functional status as measured JR, Giobbie-Hurder A, Reda DJ, Itani KMF, Neumayer LA.
by the physical component score of the SF-36. In (2007) Factors associated with postoperative complica-
tions and hernia recurrence for patients undergoing in-
our cost-effectiveness analysis, we showed that
guinal hernia repair: a report from the VA Cooperative
laparoscopic repair was cost-effective for a uni- Hernia Study Group Am J Surg 194(5):611–617
lateral hernia; it is possible that the finding of a 7. McCarthy M, Chang CH, Pickard AS, Giobbie-Hurder A,
decreased physical component score in patients Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer
with chronic pain and no recurrence is respon- L. (2005) Visual analog scales for assessing surgical pain. J
Am Coll Surg 201(2):245–252
sible for this finding [9].
8. McCarthy M, Jonasson O, Chang CH, Pickard AS, Giobbie-
In addition, we have identified some other pre- Hurder A., Gibbs J, Edelman P, Fitzgibbons R, Neumayer
dictors of complications, which will require fur- L. (2005) Assessment of patient functional status after
ther investigation as to whether they themselves surgery. J Am Coll Surg 201(2):171–178
are putative risk factors or surrogates for unmea- 9. Hynes D, Sroupe K, Luo P, Giobbie-Hurder A, Reda D, Kraft
M, Itani K, Fitzgibbons R, Jonasson O, Neumayer L, for the
sured factors.
Veterans Affairs Cooperative Studies Program 456 Inves-
The strength of the VA hernia trial is that tigators. (2006) Cost-effectiveness of laparoscopic versus
it was conducted in »real-life« practices, not in open mesh hernia operation: results from a Department
highly specialized hernia or laparoscopic centers, of Veterans Affairs randomized clinical trial. J Am Coll Surg
and therefore represents the current practice of 203(4):447–457
most general surgeons. As part of the trial, data
were collected prospectively, allowing analyses of
many secondary outcomes. A limitation is that the
study was performed within the Veterans Affairs
healthcare system, in which the majority of pa-
35

Chronic Pain After Inguinal Hernia


Repair: The Choice of Prosthesis
Outweighs That of Technique
G. G. Champault
258 Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

Introduction Other risk factors for chronic pain include being


employed and having private health insurance [5].
The true incidence of chronic pain after inguinal Direct injury to nerves, resulting in either par-
herniorrhaphy is unknown, and until recently it tial or complete transection, can lead to neuroma
was a secondary consideration, with the recurrence formation and subsequent development of chronic
rate being deemed of greater importance. The inci- pain. The ilioinguinal and iliohypogastric segments
dence was reduced by the use of prostheses [1]. As of the genital branch of the genitofemoral nerves are
recurrences have declined, though, more attention vulnerable to injury; when injured, they can pro-
is now being focused on other measures of success, duce pain syndromes that are refractory to narcotic
particularly quality of life. Numerous recent studies and multidisciplinary management techniques.
have examined the incidence of chronic pain after Some authors have also implicated the role
operations. Grant et al. [2] reported that 9.7% of of mesh [13, 14]. Demirer et al. [15] showed that
their patients experienced chronic pain after surgery, when peripheral nerve tissue comes in contact
and other studies [3–6] have put the figure as high with polypropylene mesh, myelin degeneration as-
as 34%. Typically, such complaints decrease over the sociated with edema and fibrosis occurs. However,
course of the first year [7], but a significant number multiple studies have examined this issue, and the
of patients do develop chronic and debilitating pain weight of the evidence seems to indicate that mesh
[8]. With the recognition that this is more common does not significantly increase the risk of chronic
than was previously realized, numerous authors have pain [8, 10, 16].
begun to investigate the impact of pain on quality of Operative technique may also play a role. No
life [9, 10]. Various factors have been examined to particular surgical approach has proved superior
determine the etiology of postoperative pain. in terms of subsequent pain, although data sug-
Patient age has been implicated, with the avail- gest that the laparoscopic procedure [17] may be
able data indicating that younger patients have a more beneficial. Douek et al. [18] found that after
higher likelihood of postoperative pain [5, 10]. But 5 years, the transabdominal preperitoneal proce-
a recent study [7] refuted this notion, finding that dure resulted in significantly less pain than an
the incidence of chronic pain is evenly distributed open tension-free mesh repair (2% vs. 10%). In
among age groups. contrast, the largest study [19] to date comparing
Preoperative pain seems to be a risk factor, open techniques with laparoscopy found no differ-
with multiple studies [5, 6] showing that those ences after 3 months.
who report pain beforehand are more likely to de- Multiple studies have examined the role of
velop chronic pain afterward. mesh. The etiological factors include irritation or
Certain individuals can be physiologically or damage of inguinal nerves by sutures or mesh [13],
psychologically predisposed to develop chronic an inflammatory reaction against the mesh [20],
pain. Courtney et al. [8] found that patients with or simply scar tissue. A recent systematic review of
35 such symptoms after herniorrhaphy are more mesh techniques compared with nonmesh meth-
likely than most other people to suffer from other ods pointed out that no strong evidence indicated
chronic pain conditions. Body habitus may play a that the use of mesh increased the rate of chronic
role here because obese patients can have a higher pain [1]. Recent studies [3] have pointed out that
incidence of postoperative inguinodynia [10]. »mesh-induced pain« occurs more frequently than
Ferzli et al. [11] found that the probability of reported, including in tension-free techniques.
developing chronic pain was more than twofold Amid [21] identified »meshoma« as a radiologic
higher in those undergoing ambulatory hernior- entity and pathologic cause of chronic pain. Me-
rhaphy. The type of anesthetic administered has shoma occurs when the mesh prosthesis becomes
been examined as a possible factor in this problem. wadded into a ball because of nonfixation, insuf-
Nordin et al. [12] showed that local anesthesia was ficient fixation, or insufficient dissection to make
associated with less chronic pain than regional or adequate room for the prosthesis. In other situa-
general anesthesia. tions, the weight of the evidence seems to indicate
Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis
259 35
that mesh does not significantly increase the risk Lichtenstein technique or laparoscopy, using two
of chronic pain [10, 16, 18]. types of prostheses: polypropylene and beta-D-glu-
But research into alternatives to polypropylene can-coated polypropylene (Glucamesh, Genzyme
continues. Cobb et al. [22] have advocated the use France). Glucan-coated prostheses are composed
of newer lightweight polypropylene, which may in of an unwoven polypropylene mesh that is coated
theory result in less foreign body response and with beta–(1→3),(1→4)-D-glucan, a complex car-
would improve operative outcomes. Post et al. [23] bohydrate extract of oat. Oat beta-glucan is an
reported that after 6 months of follow-up, light- entirely (100%) natural plant product that has been
weight polypropylene mesh is preferable to con- used in burn and wound care applications [28–30].
ventional mesh for Lichtenstein repair of inguinal Beta-glucans have also been the subject of research
hernia. After this study, two randomized studies regarding their roles as immunomodulators [31–34]
[24, 25] reported that use of a partially absorbable and agents in wound healing [35, 36].
lightweight mesh was associated with less chronic
pain than a nonabsorbable heavy mesh after 1 and
3 years. The frequency of recurrence was similar for Patients and Methods
the two meshes. A recent laparoscopic study indi-
cated that fewer postoperative complications and an Patients
improved quality of life can be achieved by reduc-
ing the amount of polypropylene in meshes used Between 2001 and 2003, 410 consecutive patients
for laparoscopic hernia repair [26]. Foreign body (396 men, 14 women) of mean age 54 years (range
sensations were also fewer for lightweight meshes 18–84) underwent repair of inguinal hernias, 96
compared with conventional polypropylene mesh. (23%) of which were bilateral and 56 (13%) recur-
In this study, Horstmann et al. [26] followed their rent. Most patients (95%) were classified as Ameri-
patients only 1 year after surgery, when a foreign can Society of Anesthesiologists (ASA) physical
body sensation is more common than after 2 years. status I or II [8], and 72 (17.5%) of them had a
On the other hand, Paajanen [14] recently body mass index (BMI) above 30.
compared three different meshes [partially absorb-
able polypropylene–polyglactin mesh, lightweight
polypropylene mesh (55 g/m2), and conventional Methods
densely woven polypropylene mesh] in a random-
ized trial of 228 patients (232 hernias) treated by All surgery was done under general anesthesia by
Lichtenstein tension-free hernioplasty under local four surgeons. Thrombosis prophylaxis and anti-
anesthesia in same-day surgery by the same sur- biotic prophylaxis were used in all cases. Lichten-
geon using exactly the same surgical technique. He stein repair was performed as first described [9].
found no differences in pain or quality of life after The prosthesis was fixed at the inguinal ligament
2 years of follow-up. with five to seven stitches of polypropylene. In lap-
The nature and quality of prostheses have aroscopic repair (totally extraperitoneal approach,
evolved over the last 10 years, with polypropylene or TEP), the Retzius space was developed and
being the most common material. Many prosthe- insufflated using three trocars. Prostheses were not
ses have offered additional refinements: anatomi- fixed. This technique was preferred for bilateral
cal molding; inclusion of elements to reduce the hernias or for hernias that recurred after hernior-
residual mass of nonresorbable material, thereby rhaphy in young (20–45 years) active professionals
diminishing complications; and, recently, coatings or sportsmen or women with no anesthetic risk
of substances that assist in tissue acceptance and and a BMI under 30. All other patients underwent
integration. Lichtenstein repair.
We performed a study [27] to prospectively as- Two types of prosthesis were used: polypropyl-
sess the results at 2-year follow-up in patients who ene of weight per unit area 105 g/m2 (Bard, Ethi-
underwent tension-free hernia repair by either the con) and polypropylene of weight per unit area
260 Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

50 g/m2 coated with beta-D-glucan (Glucamesh; each of these two groups, the populations were
Genzyme France), a plant derivative (oat) that comparable in terms of age, gender, type of hernia,
promotes healing and has an immunomodulatory ASA score, and incidence of obesity. The mean du-
effect. ration of hospitalization was 2.82 days (range 1–5),
Patients were randomly assigned to the two independent of the technique or mesh.
groups depending on whether they agreed to be Two-year follow-up was possible in 85.1% of
included in a prospective study [10]. patients (n=349: 117 TEP, 232 Lichtenstein) and
All patients were followed up prospectively was comparable for the two techniques used.
for at least 2 years by a surgeon not involved in At 2 years, recurrence had occurred in 10 cases
the study. Recurrence was confirmed by physical (2.8%) and was independent of the technique [TEP
examination or repeat surgery. Chronic pain was n=2/117 (1.7%) vs. Lichtenstein n=8/232 (3.4%),
assessed using a visual analog scale (VAS) and a not significant] or of the type of mesh [Glucamesh
validated questionnaire [11]. Pain was considered n=2/104 (1.9%) vs. polypropylene n=8/245 (2.4%),
mild for a VAS score below 3, moderate below 5, not significant]. (⊡ Table 35.1).
and severe or debilitating above 5. At 2 years of follow-up, 69 patients presented
with residual mild (VAS<3) or moderate (VAS<5;
19.7%) pain and 11 with intense pain (VAS>5;
Statistics 3.1%). Moderate pain (⊡ Tables 35.2 and 35.3) was
significantly less frequent (p=0.05) with Glu-
Quantitative values are given as means ± standard camesh than with polypropylene mesh (4.8% vs.
deviation. The Kruskal–Wallis test or Wilcoxon 26.1%) irrespective of the repair technique (6.5%
test was used for (nonparametric) comparison of vs. 27.2% for laparoscopy; 3.7% vs. 25.6% for Lich-
the two groups. For qualitative parameters, per- tenstein). There was no significant difference be-
centages were compared using the chi-square test. tween the two techniques in the Glucamesh group
Differences were considered statistically significant (6.5% vs. 3.7%) or the polypropylene mesh group
for p-values <0.05. The statistical analyses were (27.2% vs. 25.6%). This was also true for chronic,
done using SPSS 10.0 software for Windows. severe, debilitating pain (⊡ Tables 35.4 and 35.5).
Pain characteristics were comparable whatever the
repair technique (⊡ Table 35.6).
Results

Lichtenstein repair was done in 273 (66.5%) pa- Discussion


tients, with polypropylene mesh in 215 (78.7%)
and Glucamesh in 58 (21.3%). Laparoscopic repair There is no consensus concerning the repair tech-
was used in 137 patients, with polypropylene mesh nique for inguinal hernia. However, it is clear that
35 in 80 (58.4%) and Glucamesh in 57 (41.6%). In the use of prosthetic strengthening significantly

⊡ Table 35.1. Two-year recurrence (n%) as a function of technique and mesh (ns not significant)

n Recurrence % p

Lichtenstein 232 8 3.4 ns

Laparoscopy 117 2 1.7 ns

Glucamesh 104 2 1.9 ns

Polypropylene 245 8 2.4 ns

Total 349 10 28
Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis
261 35
reduces the incidence of recurrence [37]. Tension- repair, which is now the most widespread tech-
free techniques may reduce the incidence of re- nique because of its advantages in terms of cost,
sidual pain [9, 10]. This explains the preference risk, and simplicity. Nonetheless, the indications
for the laparoscopic approach and for Lichtenstein for laparoscopic repair are still subject to debate.

⊡ Table 35.2. Incidence of chronic pain (n%) as a function of technique (ns not significant)

Laparoscopy Lichtenstein Total p

Glucamesh 3/51 (6.5%) 2/53 (3.7%) 5/104 (4.8%) ns

Polypropylene 18/66 (27.2%) 46/179 (25.6%) 64/245 (26.5%) ns

Total 21/117 (17.9%) 48/232 (20.6%) 69/349 (19.7%) ns

⊡ Table 35.3. Incidence of chronic pain (n%) as a function of mesh

Glucamesh Polypropylene p

Totally extraperitoneal approach 3/51 (6.5%) 18/66 (27.2%) p=0.02

Lichtenstein 2/53 (3.7%) 46/179 (25.6%) p=0.02

Total 5/104 (4.8%) 64/245 (26.5%) p=0.02

⊡ Table 35.4. Incidence of severe pain (visual analog score >5) as a function of technique (ns not significant)

Laparoscopy Lichtenstein Total p

Glucamesh 1/51 (1.9%) 0/53 (0%) 1/104 (0.9%) ns

Polypropylene 3/66 (4.5%) 7/179 (3.3%) 10/245 (4%) ns

Total 4/117 (3.4%) 7/232 (3%) 11/349 (3.1%) ns

⊡ Table 35.5. Incidence of severe pain (visual analog score >5) as a function of mesh

Glucamesh Polypropylene p

Totally extraperitoneal approach 1/51 (1.9%) 3/66 (4.5%) p=0.27

Lichtenstein 0/53 (0%) 7/179 (3.3%) p=0.02

Total 1/104 (0.9%) 10/245 (4%) p=0.02

⊡ Table 35.6. Location of pain (ns not significant)

Glucamesh Polypropylene p

Groin 67% 77% ns

Testicle 50% 34% ns


262 Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

We used laparoscopy in young, nonobese patients Chronic pain after hernia repair has been stud-
with bilateral or recurrent hernia who were ac- ied extensively [3, 6, 17, 43] but is difficult to as-
tive professionally or in sports and who had no sess. Specific validated questionnaires [42, 44] have
anesthetic risk. We applied the same indications to been developed to evaluate and compare quality of
the laparoscopic and Lichtenstein groups, which life as a function of technique. Numerous factors
were therefore perfectly comparable. The reported have been implicated: anatomical factors (nerves),
2-year recurrence rate is comparable for Lichten- type of hernia, technique, surgical field, and also
stein repair and laparoscopic repair (2–5%) [38, the mesh and its fixation. In our practice, the
39], which accords with our experience (2.8%) in meshes used in TEP are not fixed, and those used
which this incidence was independent of the tech- in Lichtenstein repair are fixed with a few sutures
nique or the prosthetic mesh. on the inguinal ligament. At 2-year follow-up,
The choice of prosthesis is even less well these techniques were identical in comparable
defined and subject to criteria that are often cost- groups of patients, whatever the type of prosthesis
related and subjective or personal. The character- used. There was no difference in chronic pain, or
istics of the ideal prosthesis are well defined: large even in pain qualified as severe, between TEP and
mesh, solid, flexible, low specific weight, ability to Lichtenstein repair. There was, however, a signifi-
become incorporated in tissues, and biologically cant difference in favor of Glucamesh compared
inert. Most meshes are made of polypropylene or with polypropylene mesh in the groups compared,
polyester. Using these principles, a great variety irrespective of the repair technique. These advan-
of products have been developed and adapted to tages may stem from the low weight per unit area
techniques or practices (laparoscopy): composite, of Glucamesh but above all from the quality of the
two-faced meshes that are coated to promote beta-D-glucan coating.
healing and facilitate tissue integration. Coat-
ing with animal collagen has proved effective
but carries a small biological risk (cattle) or is Conclusion
subject to religious restrictions (pig). Beta-D-
glucan is an entirely natural plant product that Our findings suggest that at 2-year follow-up, the
promotes healing and has an immunomodula- quality of hernia repair in terms of efficacy and
tory effect [29, 31, 33, 34]. Beta-D-glucan-coated quality of life is determined more by the character-
meshes are effective in terms of recurrence, qual- istics of the prosthesis than by the technique used.
ity of life, and chronic pain [40, 41]. In the pres-
ent study, we have shown that the 2-year recur-
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39. Wara P, Bay Nielsen M, Jul P, Bendix J, Kehlet H (2005). cilitate the integration in the muscle and secondly
Prospective nationwide analysis of laparoscopic versus to avoid an adherence. And that is a paradox. In
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1281
40. Barrat C, Seriser F, Arnoud R, Trouette P, Champault G ing the usefulness of collagens. And the company
(2004). Inguinal hernia repair with beta glucan coated (Covidien) have put the same prosthesis without
mesh: prospective multicenter study (115 cases). Prelimi- collagen on the market – to be in the prize only!
nary results. Hernia 8, 33–38 Post: You cannot differentiate the difference be-
41. Champault G, Barrat C (2005) Inguinal hernia repair with
tween the effect of lightweight and heavyweight
beta glucan coated mesh: results at two years follow up.
Hernia 9, 125–130 and the glucan. So it might be hypothesized that
42. Conze J, Kingsnorth AN, Flament JB, Simmermacker P, the only difference is due to the light weight and
Arlt G, Langer C, Shippers E, Hartley A, Schlumpelick V not to glucan. In your randomized trial you started
(2005). Randomized clinical trial comparing lightweight just now, do you compare the same lightweight
composite mesh with polyester or polypropylene mesh
with and without glucan?
for incisional hernia repair. Br J Surg 92, 1488–1493
43. Khan LR, Kumar S, Nixon SJ (2006). Early results for new Champault: It probably will be the next trial.
lightweight mesh in laparoscopic totally extraperitoneal Smeds: Very interesting results. In order to under-
inguinal hernia repair. Hernia 10, 303–308 stand the mechanisms more, I am just curious to
know whether you allocated the surgeons to the
different type of meshes. Did you have the poly-
Discussion propylene surgeons and the glucan surgeons? Be-
cause we know that there is a significant difference
Schumpelick: Thank you very much for this pre- if you are a high-volume surgeon or a low-volume
sentation, I think these are excellent results. How surgeon.
do you explain your results? How is glucan work- Champault: No, the same surgeons. In a previous
ing? study we have shown that the results of trainees
Champault: I think there are three explanations: are the same as the results of consultants or more
First, it’s a lightweight mesh. Second, there is no experienced surgeons. In this study, the repairs
fixation, because of adhesiveness. Especially in TEP were performed within the whole group of our
hernia repair we do not fix the mesh anymore. surgeons.
Schumpelick: Is glucan like a glue?
Champault: There is no glue on this mesh. But
when you use this mesh in TEP hernia repair and
you put the mesh directly on the muscle, you don’t
need any fixation or tacks. And when you perform
a Lichtenstein hernia repair, you only have to put
in the prosthesis. In this study we used the official
35 technique described by Amid with a running suture
on the inguinal ligament. And third, with regard to
the role of glucan, I have seen the use of glucan in
burned patients. There it is very efficient, and you
win many days in healing. Perhaps there is an action
in the integration of the prosthesis in the muscle and
possibly, as the experimental studies have shown, an
action of the inflammatory reactions.
Schumpelick: And then you mentioned in your
discussion the covering of meshes with collagen. Is
that not working anymore?
Champault: There is a problem with collagen be-
cause you use the same product of collagen to fa-
36

The Effect of Polypropylene


Mesh on the Ilioinguinal Nerve
in Open Mesh Repair of Groin Hernia
S. D. Demirer, I. Kepenekci, O. Evirgen, O. Birsen, A. Tuzuner,
S. Karahuseyinoglu, M. Ozban, E. Kuterdem
266 Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia

Introduction Material and Methods

Open or laparoscopic mesh repair of groin hernia Our study protocol was reviewed and approved by
is one of the most common elective operations the ethics committee of Ankara University School
performed by general surgeons. Because of low of Medicine. All animals received humane care in
recurrence rates, the concept of tension-free mesh accordance with the Guide for the Care and Use
repair methods has gained wide acceptance. The of Laboratory Animals prepared by the National
development of chronic pain after inguinal hernia Academy of Sciences and published by the U.S.
repair is a well-known long-term complication, National Institutes of Health (NIH publication No.
with the reported frequency of pain varying from 85–23, revised 1985).
0% to 37% [1–11]. Some studies have reported
a lower incidence of pain, 2–2.5%, after laparo-
scopic hernia repair than after open mesh repair Experimental Design
[3, 4, 8, 11–15]. The complaint of chronic pain
following inguinal hernia repair can continue Twenty-four New Zealand rabbits weighing 2.4–
for months or even years. Several risk factors as- 2.7 kg were included in our study. They were sub-
sociated with this have been identified, including jected to 1 week of preliminary conditioning dur-
recurrent hernia repair, the patient’s insurance ing which time they received standard chow and
status, day surgery, patient age less than 60 years, water ad lib. They were housed in a temperature-
intensity of early postoperative pain, experience and humidity-controlled environment, two per
of the surgeon, and type of surgical procedure cage, with a 12-h light–dark cycle.
used [3, 6, 9, 16]. Preoperative antibiotics (cefazolin 10 mg/kg)
Mesh inguinodynia was described as »a new were administered intramuscularly 30 min prior to
clinical syndrome« after inguinal herniorrhaphy. skin incision. The rabbits were anesthetized by an
The development of this chronic debilitating pain intramuscular injection of ketamine hydrochloride
after herniorrhaphy has been attributed to several (35 mg/kg) and Xylocaine (5 mg/kg). The animals
mechanisms, including injury or entrapment of were placed in a dorsal recumbent position, fol-
the sensory nerves (ilioinguinal, iliohypogastric, lowed by hair removal from the inguinal area. The
genitofemoral, or lateral femoral cutaneous nerves) inguinal and scrotal regions were shaved and pre-
and mesh inguinodynia [2, 3, 6–8, 17]. Partial or pared with Betadine solution. In all animals, the
complete division, neuroma formation, stretching, inguinal areas were explored bilaterally through
contusion, crushing, electrical damage, or suture an inguinal incision. The ilioinguinal nerve was
compression can injure sensory nerves in close identified on both sides and synthetic polypropyl-
proximity to the operative field and cause neu- ene mesh placed on only one side (⊡ Fig. 36.1). The
ralgia. Secondary damage to a sensory nerve may ilioinguinal nerve was in touch with polypropylene
also result from scar tissue compression or from ir- mesh on this side (⊡ Fig. 36.2). We designated the
ritation by an adjacent inflammatory process such right groin as the control and the left groin as the
36 as a suture granuloma or mesh. Polypropylene experimental side in each animal. After the opera-
synthetic mesh causes inflammatory reaction and tion, the inguinal incisions were closed in anatom-
formation of scar tissue [2, 6, 8, 11, 17, 18]. ical layers with 3-0 monofilament suture.
The ilioinguinal nerve is a sensory nerve that All rabbits tolerated the surgery well, and they
is usually preserved during hernia repair, but it were followed until reexploration. Three months
can interfere with placement of the mesh and may after surgery, the animals were anesthetized using
be traumatized inadvertently during operation. In intramuscular ketamine hydrochloride, and bilat-
this experimental study, we aimed to evaluate dam- eral inguinal exploration was performed again, with
age or entrapment of the ilioinguinal nerve caused samples of nerve tissue taken from both sides. The
by polypropylene synthetic mesh after groin hernia samples of nerve tissue were divided into two groups
repair. as control and experimental groups. An internation-
Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve
267 36
and examined under a light microscope (Zeiss
Axio Scope photomicroscope). After double stain-
ing with uranyl acetate and lead citrate, ultrathin
sections were examined and photographed using a
LEO 906E transmission electron microscope.
For light microscopic study, inguinal periph-
eral nerve tissues were fixed in 10% formaldehyde.
Samples were dehydrated by immersion in a series
of alcohol concentrations and embedded in paraf-
fin; 5-μm sections were stained with hematoxylin
and eosin (H&E) and Masson’s trichrome and
examined under a light microscope.

⊡ Fig. 36.1. Ilioinguinal nerve of the rabbit after dissection

Morphometric Analysis

For morphometric analysis, photographic color


images from semithin sections of experimental
and control groups were obtained with the Zeiss
Axio Scope photomicroscope at ×250 magnifica-
tion. The measurements were obtained using Adobe
Photoshop 7.0 software. The graphic file format
of the images is JPEG, and resolution was set at
500 pixels per inch. Myelinated fiber diameter, axon
diameter, G-ratio (axon diameter/myelinated fiber
diameter), myelin thickness, and the numbers of
nerve fibers with diameters of ≤4 μm, 5–8 μm, and
≥9 μm were assessed in a blinded fashion using a
⊡ Fig. 36.2. Polypropylene mesh was laid in close proximity to semiautomated procedure [20].
the ilioinguinal nerve

Statistics
ally accepted standard definition of pain persisting
beyond the normal tissue healing time, assumed to Statistical analysis was performed using the ad-
be 3 months, was used in our study [19]. justed Student‘s t-test for clustered data and the
adjusted chi-square test for clustered binary data,
comparing the mesh-laid side of each group to the
Histological Tissue Processing control side of the same group. A p-value <0.05
denoted a statistically significant difference.
For electron microscopic study, inguinal periph-
eral nerve specimens from the control and ex-
perimental groups were fixed in 2.5% glutaralde- Results
hyde in 0.1 M phosphate buffer and postfixed in
1% osmium tetroxide. Tissue samples were dehy- No intraoperative or postoperative deaths occurred
drated through a graded series of ethanol and in the rabbits, and we observed no infective com-
propylene oxide embedded in araldite. Semithin plications in either the control or the experimental
sections were stained with toluidine blue-Azure II sides during 3 months of follow-up. There was
268 Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia

a statistically significant difference between the


mean operating times in the two groups (13 min
in the control group vs. 24 min in the experimental
group, p<0.05). During reexploration, we found
macroscopically dense fibrotic tissues encompass-
ing the polypropylene mesh and adhesions on the
study side 3 months after surgery. On the experi-
mental side, the floor of the inguinal region was
very tight, and dissection as well as removal of the
ilioinguinal nerve was difficult because of fibrotic
changes. The nerve had thickened and adhered to
the mesh and adjacent inguinal region. There was
minimal fibrosis on the control side; therefore, the
ilioinguinal nerve was divided and removed easily
on this side. a

Histological and Morphometric


Assessment

H&E-stained sections from the experimental group


after 3 months revealed inflammatory reaction
and increased connective tissue that formed ar-
eas of fibrosis around polypropylene mesh islands
(⊡ Fig. 36.3a, b). Light microscopic examination of
H&E-stained and Masson’s trichrome-stained sec-
tions of peripheral nerves from the control group
were normal in appearance (⊡ Fig. 36.4a, b), but the
nerve fascicles in the experimental group operated
with mesh showed axonal dilatation and mild to
severe loss of myelinated axons (⊡ Fig. 36.5a, b).
b
Examination of semithin sections of peripheral
nerve fascicles from the control group showed
⊡ Fig. 36.3. Experimental group at the 3rd postoperative
almost intact myelinated and unmyelinated fibers
month: interface of the mesh and recipient tissue (pmg po-
(⊡ Fig. 36.5c). The endoneurium of closely located lypropylene mesh graft). Double asterisks (**) indicate con-
myelinated fibers appeared to be normal. Most nective tissue around polypropylene mesh islands (patches)
of the myelin sheath layers and the thickness of forming fibrosis and inflammatory reaction. Arrowheads show
36 equal-size fibers were the same and showed nor- striated muscle. a Original magnification ×100. b Original ma-
gnification ×200. Hematoxylin–eosin staining
mal morphology.
Electron microscopic examination of semithin
and ultrathin sections of nerve morphology in the
experimental group operated with mesh exhibited bers in the experimental group showed undulation
endoneurial edema with thickening of both the toward the axoplasm and the endoneurium. In the
endoneurium and perineurium, causing separa- experimental group we also observed separation
tion of nerve fibers (⊡ Fig. 36.5d, d insert). A few of myelin layers from each other as a prominent
extra layers of connective tissue formation in some feature of myelin degeneration in nerve fibers.
nerve fibers of the experimental group suggested Axoplasms also exhibited edema and crystalliza-
early onion-bulb formations. Myelin sheaths of fi- tion (⊡ Fig. 36.6a–d).
Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve
269 36
Results of the morphometric assessment are
outlined in ⊡ Table 36.1. Fiber diameter and ax-
onal diameter were increased in the experimental
group compared with the controls as a result of
axonal dilatation, and this difference was statisti-
cally significant. The G-ratio, which is considered
normal in the range of 0.60–0.64, increased in the
experimental group compared with controls as a
result of myelin sheath thinning; the difference
was statistically significant. Myelin thickness was
decreased moderately on the mesh side compared
with the control side, but there was no statis-
tically significant difference between them. The
number of nerve fibers considered healthy, with a
diameter <9 μm, was higher in the control group
a
than in the experimental group (Pcontrol=0.783 vs.
Pmesh=0.570), and the difference was statistically
significant (p<0.001) with an adjusted chi-square
test for clustered binary data.

Discussion

It is usual to preserve the ilioinguinal nerve, but


it can interfere with placement of the mesh and
may be traumatized inadvertently during opera-
tion. The increased surface area of the mesh might
allow adherence of nerves or abrasion and account
for an increased risk of neuropathic pain.
Using prosthetic mesh for inguinal hernia re-
pair is well accepted. But despite favorable clinical
outcomes, patients who undergo mesh hernia re-
b
pair may complain of severe, debilitating pain and
pose a bothersome chronic management problem
⊡ Fig. 36.4. Light microscopic images of peripheral nerves of
control group. a Arrowhead axon; arrow Schwann cell nucleus; [1, 21, 22]. Local analgesic or steroid injections,
E endoneurium; P perineurium; Ep epineurium. Original ma- various pharmaceuticals, behavioral therapy, cryo-
gnification ×400. Masson’s trichrome staining. b Arrowheads therapy, alcohol or phenol injections, neurectomy,
axons; arrow Schwann cell nucleus. Original magnification and mesh removal are frequently used in treatment
×400. Hematoxylin–eosin staining
[2, 18]. Delayed presentations of mesh inguino-

⊡ Table 36.1. Peripheral nerve morphometry

Average fiber diameter, Average axon diameter, Average G-ratio, Myelin thickness,
mean ± SD mean ± SD mean ± SD mean ± SD

Mesh side 9.05±0.24a 6.17±0.11a 0.68±0.007a 1.98±0.11

Control side 6.91±0.14 4.17±0.09 0.59±0.004 2.73±0.06


ap<0.001
significant with adjusted Student’s t-test for clustered data
270 Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia

dynia may occur, possibly secondary to chronic bioprosthesis and its resulting fibrotic reaction on
scarring or neuroma formation. The mesh as a adjacent structures such as the spermatic cord or
foreign body induces a dense fibroblastic response, peripheral nerves in the inguinal region [23–28].
creating scar tissue and imparting strength to the In our study we aimed to evaluate the local
floor. Despite wide acceptance of this technique, effects of mesh on the ilioinguinal nerve. Histo-
there is little data regarding the effects of the mesh pathological and morphometric changes of the

a b

36

d
c

⊡ Fig. 36.5. a,b Light microscopic images of experimental sections of peripheral nerves. c Arrow myelin sheath; asterisks
group. a Asterisks axonal loss; P perineurium; Ep epineurium; unmyelinated nerves; P perineurium. Original magnification
arrowhead Schwann cell nucleus; arrows axons. Original mag- ×1,000. Toluidine blue staining. d, d insert Arrowheads extra
nification ×400. Hematoxylin–eosin staining. b Asterisks axonal collagen fiber layers (onion-bulb formation); asterisks separati-
loss; arrow axon; arrowhead Schwann cell nucleus; P perineu- on of myelin sheath; arrows undulation of myelin sheath; P peri-
rium; Ep epineurium; E endoneurium. Original magnification neurium; Ep epineurium; double asterisks Schwann cell nucleus.
×400. Masson’s trichrome staining. c, d, d insert Semithin Original magnification ×1,000. Toluidine blue staining
Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve
271 36
ilioinguinal nerve in the mesh group (mentioned lowing inguinal hernia repair. But it is difficult
in the results section of this paper), such as axonal to make a definitive statement regarding the im-
dilatation, loss of myelinated axons, endoneurial pact of these histopathological changes on chronic
edema, separation of myelin layers, increased fiber pain because animal models, not human beings,
and axon diameters, and increased G-ratio, may were used in this experimental study. It is very
be implicated in the etiology of chronic pain fol- well known that pain is a subjective complaint;

a b

c d

⊡ Fig. 36.6. Transmission electron microscopic (TEM) images sheath. TEM ×2,784. c c collagen fibers; double asterisks endo-
of experimental group. a Axp axonal dilatations and axoplasm; neurial edema; umyn unmyelinated nerves; SCCy Schwann cell
double asterisks myelin sheath separation; umyn unmyelinated cytoplasm; myelin sheath. TEM ×4,646. d Axp crystallization of
nerves; SCCy Schwann cell cytoplasm. TEM ×3,597. b Double nerve fibers in axoplasm; double asterisks endoneurial edema;
asterisks extra collagen fibers around endoneurium sugges- L lipid droplets; asterisks inclusion body in Schwann cell cyto-
ting onion-bulb formation; arrows myelin sheath degenera- plasm; SCCy Schwann cell cytoplasm; arrowhead degenerative
tion and separation; asterisks myelin undulation; ms myelin inclusions between myelin layers. TEM ×12,930
272 Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia

certainly, scaling and establishment of correlation Placement of mesh in direct contact with ingui-
with these histopathological changes cannot be nal nerves is not recommended for avoiding groin
done in animal models. pain [2–4, 6–8, 17]. Tsakayannis et al. [31] reported
Polypropylene mesh serves as a flexible lat- that even elective neurectomy is safe to perform
tice supporting the ingrowth of connective tissues and is not associated with chronic inguinal pain.
from the base of the wound and is known to incite Our study indicates that preservation of the ingui-
a prompt fibroblastic response, imparting strength nal nerves is important in mesh herniorrhaphy be-
to the repair. An extensive inflammatory and fi- cause of the mesh-induced changes that occur. We
broblastic granulomatous reaction occurs in re- conclude that the sensory nerves in the inguinal
sponse to the foreign material, which causes dense region should be better separated from the mesh
adhesions when the material is placed adjacent to and preserved carefully in order to prevent chronic
visceral organs [29, 30]. According to our macro- groin pain when mesh repair is performed. Further
scopic and microscopic findings, the ilioinguinal studies are needed to evaluate the effect of anatomi-
nerve was affected by the resultant fibrotic reaction cal position and the relationship of mesh and sen-
to the mesh (⊡ Fig. 36.3a, b). Peripheral neuropathy sory nerves to chronic pain after herniorrhaphy.
following mesh herniorrhaphy was most likely due
to incorporation of adjacent nerve fibers in the
fibroblastic reaction incited by mesh. During the References
reexploration, we performed extensive dissection
to find and ensure adequate mobilization for the 1. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. Cause
and prevention of postherniorrhaphy neuralgia: a proposed
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protocol for treatment. Am J Surg 1988;155:786–790
in the experimental group. It has been argued that 2. Helse CP, Starling JR. Mesh inguinodynia: a new clinical
several factors may contribute to the development syndrome after inguinal herniorrhaphy? J Am Coll Surg
of chronic groin pain; one of these factors may 1998;187:514–518
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impairment 1 year after inguinal herniorrhaphy: a nation-
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wide questionnaire study. Ann Surg 2001;233:1–7
on the posterior inguinal wall. Chronic groin pain 4. Callesen T, Bech K, Nielsen R, Andersen J, Hesselfeldt P,
after hernia repair can possibly be caused by the Roikjaer O, Kehlet H. Pain after groin hernia repair. Br J
entrapment of peripheral nerves in the scar tissue Surg 1998;85:1412–1414
formed by the mesh [2–4, 6–8, 17]. 5. Haapaniemi S, Nilson E. Recurrence and pain three years
after groin hernia repair. Vallidation of postal question-
Uzzo et al. [27] demonstrated that entrapment
naire and physical examination as a method of follow-up.
of the ilioinguinal nerve or its branches by the Eur J Surg 2002;168:22–28
mesh reaction gave rise to a traumatic neuroma. In 6. Callesen T, Bech K, Kehlet H. Prospective study of chronic
our study, the light microscopic and ultrastructural pain after groin hernia repair. Br J Surg 1999;86:1528–
changes seen in peripheral nerves in the experi- 1531
7. Ravichandran D, Kalambe BG, Pain JA. Pilot randomized
mental group operated with mesh suggest that me- controlled study of preservation or division of ilioinguinal
chanical compression of peripheral nerves is asso- nevre in open mesh repair of inguinal hernia. Br J Surg
36 ciated with myelin degeneration, endoneurial and 2000;87:1166–1167
perineurial edema, thickening of collagen layers 8. Kumar S, Wilson RG, Nixon SJ, Macintyre IMC. Chronic pain
around axons (called onion-bulb formation), and after laparoscopic and open mesh repair of groin hernia.
Br J Surg 2002;89:1476–1479
axonal loss that may cause chronic inflammatory 9. Poobalan AS, Bruce J, King PM, et al. Chronic pain and
demyelinating peripheral neuropathy. We think quality of life following open inguinal hernia repair. Br J
that inflammatory and fibrotic reactions occur- Surg 2001;88:1122–1126
ring in response to the foreign material may have 10. Courtney CA, Duffy K, Serpell MG, et al. Outcome of pa-
tients with severe chronic pain following repair of groin
caused adhesions and mechanical compression of
hernia. Br J Surg 2002;89:1310–1314
peripheral nerves, and we conclude that a similar 11. The MRC Laparoscopic Groin Hernia Trial Group. Laparo-
mechanism may be responsible in part for chronic scopic versus open repair of groin hernia: a randomized
groin pain in humans. comparison. Lancet 1999;354:185–190
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273 36
12. Seid AS, Amos E. Entrapment neuropathy in laparoscopic 29. Lichtenstein IL. Herniorrhaphy Am J Surg 1987;153:553
herniorrhaphy. Surg Endosc 1994;8:1050–1053 30. Wagner M. Evaluation of diverse plastic and cutis prosthe-
13. Liem MS, van der Graaf Y, van Steensel CJ, et al. com- ses in a growing host. Surg Gynecol Obstet 1970;130:1077
parison of conventional anterior surgery and laparo- 31. Tsakayannis DE, Kiriakopoulos AC, Linos DA. Elective
scopic surgery for inguinal hernia repair. N Eng J Med neurectomy during open tension free inguinal hernia
1997;336:1541–1547 repair. Hernia 2004;8:67–69
14. Dirksen CD, Beets GL, Go PM, et al. Bassini repair compared
with laparoscopic repair for primary inguinal hernia: a
randomized controlled trial. Eur J Surg 1998;164:439–447
15. Hay JM, Boudet MJ, Fingerhut A, et al. Shouldice inguinal
hernia repair in the male adult: the gold standard? A
Discussion
multicenter controlled trial in 1,578 patients. Ann Surg
1995;222:719–727 Amid: Many congratulations on your study. We
16. Salcedo-Wasicek MC, Thirlby RC. Postoperative course af-
were inspired by your work and started doing
ter inguinal herniorrhaphy. A case controlled comparison
of patients receiving workers’ compensation vs. commer-
the same thing on human subjects. We are doing
cial insurance. Arch Surg 1995;130:29–32 exactly what you did on the nerves that you are
17. Bower S, Moore BB, Stephen MW. Neuralgia after inguinal removing from patients who have pain. And our
hernia repair. Am Surg 1996;62:664–667 preliminary result is completely consistent with
18. Wantz GE. Testicular atrophy and chronic residual neural-
your report. The only thing is that because we are
gia as risks of inguinal hernioplasty. Surg Clin North Am
1993;73:571–581 doing it on humans, we know that these changes
19. Classification of chronic pain. Descriptions of chronic pain are causing pain, whereas in your rabbits you do
syndromes and definitions of pain terms. Prepared by the not know if they are feeling pain. Your work was
International Association for the Study of Pain, Subcom- inspiration for our ongoing work. On a micro-
mittee on Taxonomy. Pain 1986;3 (suppl):S1–226
20. Campadelli P, Gangai C, Pasquale P. Automated morpho-
scopic point of view, when you remove the mesh
metric analysis in peripheral neuropathies. Comput Biol with the nerve, did you observe some adhesions of
Med 1999;29:147–156 the nerves to the mesh?
21. Shulman AG, Amid PK, Lichtenstein IL. The safety of mesh Demirer: Yes, of course. After 3 months we ex-
repair for primary inguinal hernias: results of 3,019 opera-
plored again. Here we observed on the experimen-
tions from five diverse surgical sources. Am J Surg 1992;
58:255–257
tal side a very dense fibrotic tissue and adhesion
22. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The formation as compared to the control side.
tension-free hernioplasty. Am J Surg 1989;157:188–193 Smeds: Did you check how far away from the ad-
23. Amid PK, Shulman AG, Lichtenstein IL. Critical scrutiny hesion area the nerves were changed? Did you test
of the open tension free hernioplasty. Am J Surg 1993;
it outside of the operation field as well?
165:369
24. Arnould JP, Eloy R, Weill-Bousson M, et al. Resistance et Demirer: No.
tolerance biologique de 6 prostheses insertes utilizes Ramshaw: How would you translate this research
dans la reparation de la paroi abdominale. J Chir 1977; in terms of clinical patient benefit?
113:85–100 Demirer: In my clinic we now only use polypro-
25. Usher FC, Wallace SA. Tissue reaction to plastic, a compari-
pylene meshes, and 2–5% of patients complain of
son of nylon, Orlon, Dacron, Teflon and Marlex. Arch Surg
1958:76:997–1003 pain.
26. Walker AP. Biomaterials in hernia repair. In: Nyhus LM, Schumpelick: What did the neuropathologists say
Condon RE (eds). Hernia, 4th edn. Lippincott, Philadel- to you about these findings? Have they seen such
phia, 1995:534–540 alterations of nerves before?
27. Uzzo RG, Lemarck GE, Morrissey KP, et al. The effects of
mesh bioprosthesis on the spermatic cord structures:
Demirer: We did not ask the neuropathologists.
a preliminary report in a canine model. J Urol 1999; Deysine: Have you considered conduction studies
161:1344–1349 on those pieces of nerves that you took out?
28. Shin D, Lipshultz LI, Goldstein M, Barme GA, Eugene FF, Demirer: In the next studies we should investigate
Nagler HM, McCallum SW, Niederberger CS, Schoor RA,
degenerative changes by nerve physiologists. In
Burgh VM, Honig SC. Herniorrhaphy with polypropyl-
ene mesh causing inguinal vassal obstruction: a pre-
this study we did not perform such analyses.
ventable cause of obstructive azoospermia. Ann Surg
2005;241:553–558
37

Lightweight Macroporous Mesh


vs. Standard Polypropylene Mesh
in Lichtenstein Hernioplasty
S. Bringman
276 Chapter 37 · Lightweight Macroporous Mesh vs. Standard Polypropylene Mesh in Lichtenstein Hernioplasty

Introduction than in the LW mesh group (p=0.025) stated that


they could feel the mesh in their groin.
A standard polypropylene mesh used in Lichten-
stein’s operation induces a strong foreign tissue
reaction with potential harmful effects [1]. A mesh Discussion
with less polypropylene and large pores could pos-
sibly be beneficial [2]. This chapter summarizes a In this Internet-based, multicenter study, it was
randomized controlled trial comparing standard demonstrated that no differences existed between
mesh and lightweight mesh [3–5]. Lichtenstein’s operation with LW mesh or with
standard mesh up to 12 months after surgery.
However, after 3 years, some aspects of pain and
Patients and Methods foreign body sensation were noted to be less in
the LW group without increasing the rate of her-
Six hundred men with a unilateral primary inguinal nia recurrence. Other authors have demonstrated
hernia were randomized through a secure Web site similar results concerning pain and foreign body
to be operated on with a Lichtenstein repair using sensation [6, 7]. One study showed an increased
either a lightweight (LW) macroporous mesh (Vy- risk of recurrence in the LW group [6], which
pro II, Ethicon, Hamburg, Germany) or a standard was estimated to be due to factors in the operative
polypropylene mesh (Prolene, Ethicon, Hamburg, technique. In the present trial we used a technique
Germany). All data were captured through the Web with a running suture, with 1-cm intervals between
site. The patients were blinded to which mesh they the large bites in the mesh. We found no difference
received. Five Swedish and one Finnish hospital concerning recurrences between the groups.
participated in the study. The patients completed In conclusion, we found no difference between
a diary with SF-36 and visual analog (VAS) pain the group that received LW mesh and the group
scales during the first 8 weeks postoperatively. After that received standard polypropylene mesh in Lich-
1 year, a questionnaire was sent to all patients. Pa- tenstein’s hernioplasty up to 12 months postopera-
tients who indicated a lump in the groin or another tively. The LW mesh did not affect recurrence rates
complaint were examined. Three years postopera- compared with standard mesh, but some aspects of
tively, the patients were examined by a blinded sur- pain and foreign body sensation were improved at
geon, and another questionnaire was completed. follow-up 3 years after surgery.

Results References

Of the total 600 patients, 301 were randomized 1. Klinge U, Klosterhalfen B, Muller M, Schumpelick V. For-
eign body reaction to meshes used for the repair of abdo-
to standard mesh and 299 to LW mesh, and 591
minal wall hernias. Eur J Surg 1999; 165(7):665–673
were operated on as allocated. The first patient 2. Junge K, Klinge U, Rosch R, Klosterhalfen B, Schumpelick
was recruited in mid-December 2000 and the last V. Functional and morphologic properties of a modi-
in April 2002. The groups were comparable with fied mesh for inguinal hernia repair. World J Surg 2002;
26(12):1472–1480
37 regard to demographic data. There were no dif-
3. Bringman S, Heikkinen TJ, Wollert S, Osterberg J, Smed-
ferences between the groups concerning return
berg S, Granlund H, et al. Early results of a single-blinded,
to work or normal activities, SF-36 scores, or VAS randomized, controlled, Internet-based multicenter trial
pain scores up to 8 weeks or at 12 months. The comparing Prolene and Vypro II mesh in Lichtenstein
recurrence rate 3 years after surgery was 3.7% after hernioplasty. Hernia 2004; 8(2):127–134
standard mesh and 3.6% after LW mesh repair. 4. Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund
H, Fellander G, et al. One year results of a randomised
The LW mesh group had less pain when rising controlled multi-centre study comparing Prolene and
from a reclining to a sitting position (p=0.03). Sig- Vypro II-mesh in Lichtenstein hernioplasty. Hernia 2005;
nificantly, more men in the standard mesh group 9(3):223–227
Chapter 37 · Lightweight Macroporous Mesh vs. Standard Polypropylene Mesh
277 37
5. Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund Jacob: There is a study that was recently pub-
H, Heikkinen TJ. Three-year results of a randomized clini- lished by Dr. Heniford and Dr. Matthews, and
cal trial of lightweight or standard polypropylene mesh in
they looked at Ki67 and the continuing cell turn-
Lichtenstein repair of primary inguinal hernia. Br J Surg
2006; 93(9):1056–1059 over for the different mesh products—I think they
6. O’Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers used a rabbit model. They found that the heavy-
B, Horeyseck G. Randomized clinical trial assessing impact weight product actually had continuing cell turn-
of a lightweight or heavyweight mesh on chronic pain over at a year compared to the lightweight mesh,
after inguinal hernia repair. Br J Surg 2005; 92(2):166–170
where this process actually died off. And so one
7. Post S, Weiss B, Willer M, Neufang T, Lorenz D. Randomized
clinical trial of lightweight composite mesh for Lichten- of the possibilities was that there is an ongoing
stein inguinal hernia repair. Br J Surg 2004; 91(1):44–48 cellular turnover with these heavyweight products
that is contributing to the ongoing symptoms
that you found. So the question is with this nerve
information from its contact with the mesh. One
Discussion of my partners opens the floor in all of his open
repairs and puts the mesh in the same location as
Kurzer: There are three trials now. And in the in laparoscopic repair and closes the transverse
European guidelines we are asking ourselves if the fascia over so that there is no mesh in contact
books are closed on this subject. The recommen- with the nerves running through the canal. And
dation is that the use of lightweight [mesh] can be I wondered if anyone else had thought of or has
considered in inguinal hernia repair to decrease been doing that and what their outcomes are—so,
postoperative discomfort – but it is also stated some sort of Lichtenstein repair in the preperito-
that possibly [would be] at the cost of more recur- neal space.
rences. What would be your recommendation? Champault: You are describing an operation de-
Bringman: Well, I think that the Vypro II is not scribed by my chief Jean Rives in 1963. Transingui-
the best large-pore material available now. If we nal preperitoneal prosthesis, and Volker said it was
had UltraPro when we started the trial, we would TIPP, but for me it was the Rives operation.
definitely have used that one. It is true that there Jacob: Maybe that is the direction where we have
are only some aspects where we found a difference to go back to again to avoid the nerve problem, by
in our trial. I also know that the Vicryl portion of putting the mesh to this place.
Vypro II provokes rather heavy inflammation. So I Desine: I was very impressed by the mathematical
would expect the results from an UltraPro study to description of your work—I was able to under-
make it clearer in the future stand it very well—but I am concerned that you
Post: Congratulations on the nice study. You men- had a high incidence of testicular atrophy which I
tioned that the design was single-blinded. Does cannot explain except because of technique. And
that mean that the examiner knew which type of that is what has to be emphasized for the rest of
mesh was implanted, or was the examiner was also his training. The percentage of testicular atrophy
blinded? should be below 1%.
Bringman: The examiner was blinded. Bringman: I agree.
Miserez: I presume you now use lightweight in Schumpelick: When we first used lightweight
your standard daily practice—and I have two ques- meshes in the Lichtenstein repair, we had prob-
tions on that. First, does this advantage outweigh lems in fixing this floppy mesh in front of the pu-
that of increased costs? Second, do you use it in all bic bone. Should we use a bigger overlap to avoid
patients, or are there patients with a large direct or a recurrence?
indirect hernia where you would not use a light- Bringman: We made big overlaps and a rather
weight mesh? short distance between the stitches.
Bringman: In very large defects I would use a heavy- Schumpelick: And additional stitches?
weight mesh. Now I do very little Lichtenstein any- Bringman: Additional stitches starting about 2 cm
more. I focus on laparoscopic hernia surgery. up on the medial side.
38

Does the Choice of Prosthetic


Mesh Type Make a Difference
in Postherniorrhaphy Groin Pain?
B. P. Page and P. J. O’Dwyer
280 Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy Groin Pain?

Introduction burg, Germany). This mesh has a pore size of 4 mm


and weighs 82 g/m2 at implantation and 32 g/m2 af-
Chronic pain is the most serious long-term compli- ter absorption of the polyglactin component, which
cation of inguinal hernia repair. Up to one-third of usually takes 56–70 days. The NA mesh has a pore
patients will complain of some sort of pain at 1 year size of 1 mm and weighs 85 g/m2 (Atrium, Atrium
postoperatively, and in 3–4% of patients this pain Medical, Schiphol-Rijk, Netherlands).
will be severe and disabling [1, 2]. The causes of Before operation, pain scores on a visual ana-
this pain are poorly understood, but factors such as logue scale (VAS) were measured in all patients
nerve and tissue injury may be important. Psycho- at rest and while moving, and all completed a
logical factors are also implicated, and more recently, short-form (SF)-36 questionnaire. Patients under-
the type of mesh used has been considered [3]. went open tension-free Lichtenstein mesh repair.
The most frequently used mesh type in inguinal Operative details recorded included the hernia
hernia repair is polypropylene based. These meshes type and size, any adverse events, and whether the
can be monofilament or multifilament with a closed nerves were identified and preserved or divided.
or open weave. In some patients they become very All postoperative complications were recorded, and
stiff over time, and patients complain that they can patients were telephoned with set questions at 10,
feel the mesh in their groin, while in others the 20, and 30 days after surgery to determine the inci-
mesh causes pain [4]. To overcome this, products dence of wound infection and other wound-related
have been designed that contain an absorbable and problems. Patients who reported a wound infection
a nonabsorbable component [5]. The nonabsorb- or haematoma were recalled and examined clini-
able polypropylene left in situ usually weighs about cally. Hospital stay and time to return to work and
one-third that of conventional meshes. normal activities were recorded for all patients.
The aim of this study was to compare a par- Patients were sent a VAS pain scale at 1, 3, and
tially absorbable (PA) product, Vypro II, with a 12 months, as well as a modified SF-36 question-
conventional nonabsorbable (NA) polypropylene naire. Modifications included questions about pain
mesh. The primary end point of the study was pain of any severity at the site of hernia repair (none,
at 1 year following surgery. This was assessed by very mild, mild, moderate, severe, or very severe).
visual analogue pain scores and a validated ques- Patients were also asked whether the pain was
tionnaire [2]. present all of the time, most of the time, some
of the time, a little of the time, or none of the
time. In addition, they underwent clinical review
Patients and Methods and examination at 12 months for any evidence
of chronic wound problem, testicular atrophy, or
Ethics committee approval was obtained in five development of a recurrent or contralateral hernia.
surgical units to randomise patients over 18 years Patients were also asked about any pain or numb-
of age with an inguinal hernia to receive either ness at the site of hernia repair.
PA or NA mesh using the Lichtenstein repair [6]. A sample size of 300 evaluable patients was nec-
Randomisation was computer generated with block essary to ensure an 80% power to detect a benefit of
sizes that allowed balanced recruitment within each the PA mesh of 15% for primary efficacy (incidence
centre. Patients were excluded if the hernia was of chronic pain at 12 months: NA mesh, 35%; PA
strangulated or irreducible or if they had under- mesh, 20%) at the 5% level of significance using
gone an open tension-free mesh repair previously a two-sided test. All subjects, regardless of their
38 on the same side as the current hernia. Both pa- compliance with the protocol, were included in the
tients and the staff conducting the postoperative as- analysis. For efficacy analysis, patients with missing
sessments were unaware of the treatment allocated. data for pain at 12 months were analysed using the
The PA mesh used in this study was constructed last valid observation, which was carried forward
of multifilaments of polypropylene with additional for those who did not complete a questionnaire at
absorbable polyglactin (Vypro II, Ethicon, Ham- that time point. All statistical tests were interpreted
Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy
281 38
at the 5% significance level, and 95% confidence in- graphics and the anaesthetic and operating details
tervals (CIs) were calculated when appropriate. No were similar for the two groups (⊡ Table 38.1).
adjustment for multiple testing was made.

Primary End Point


Results
There were no differences in pain as rated by
Altogether, 333 patients consented to participate in the VAS at any of the time points in the study
the study. Two patients did not fulfil the inclusion (⊡ Figs. 38.2 and 38.3). Similar numbers of patients
criteria, while 10 either withdrew consent or failed reported severe pain in both groups. Pain of any
to complete the preoperative assessments. This severity was found to be less in the PA group,
left 162 patients in the PA mesh group and 159 in 39.5% vs. 51.6%, a difference of 12.1% (95% CI:
the NA group (see ⊡ Fig. 38.1). The patient demo- -23.1 to -1.0, p=0.033; see ⊡ Table 38.2).

Consenting patients: 333

Randomised: 330

Partially absorbable (PA) group:N=166 Nonabsorbable (NA) group:N=164

Completed postoperative assessments: Completed postoperative assessments:


162 (97.6%) 159 (97%)

1-month questionnaire: 142 (85.5%) 1-month questionnaire: 135 (82.3%)

3-month questionnaire: 125 (75.3%) 3-month questionnaire: 129 (78.7%)

12-month questionnaire: 129 (78.7%)


12-month questionnaire: 137 (82.5%)

12-month clinic: 142 (86.6%)


12-month clinic: 142 (85.5%)

⊡ Fig. 38.1. Trial profile


282 Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy Groin Pain?

⊡ Fig. 38.2. Visual analogue pain scores at rest in both patient groups preoperatively and 1, 3, and 12 months after surgery
(plots are means with 95% confidence intervals)

38

⊡ Fig. 38.3. Visual analogue pain scores on movement in both patient groups measured preoperatively and at 1, 3, and 12
months after surgery (plots are means with 95% confidence intervals)
Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy
283 38

⊡ Table 38.1. Patient demographics and anaesthesia and operating details for the partially absorbable (PA) and nonab-
sorbable (NA) groups

PA group, n=162 NA group, n=159

Age (years)a 55.7 (16.4) 57.3 (15.8)

Sex ratio (M:F) 156:6 154:5


a
Body mass index 25.5 (3.4) 25.7 (3.0)

Site of hernia: Right 80 (49.9%) 86 (54.1%)


Left 82 (50.6%) 73 (45.9%)

Type of defect: Direct 64 (39.5%) 51 (32.1%)


Indirect 77 (47.5%) 78 (49.1%)
Combined 21 (13%) 30 (18.9%)

Size of defect: <1.5 cm 27 (16.7%) 24 (15.1%)


1.5–3 cm 74 (45.7%) 68 (42.8%)
>3 cm 61 (37.7%) 65 (40.9%)

Type of anaesthesia: General 90 (55.6%) 94 (59.1%)


Local 64 (39.5%) 62 (39%)
Spinal 8 (4.9%) 3 (1.9%)

Operating time (min)a 42.5 (17.2) 42.9 (16.6)

Incision length (cm)a 7.4 (1.9) 7.4 (1.5)

Nerves identified: Ilioinguinal 145 (89.5%) 146 (91.8%)


Genital 74 (45.7%) 77 (48.4%)
Iliohypogastric 10 (6.2%) 68 (42.8%)

Nerves divided: Ilioinguinal 32 (19.8%) 32 (20.1%)


Genital 13 (8%) 16 (10.1%)
Iliohypogastric 10 (6.2%) 11 (6.9%)
aValues are mean (standard deviation)

common in the PA group (⊡ Table 38.4). There


⊡ Table 38.2. Pain at 12 months in the partially
absorbable (PA) and nonabsorbable (NA) groups
was no statistical difference between groups in
terms of occurrence of testicular atrophy, wound
Any paina Severe or very severe pain sinus, or contralateral hernia when examined at
PA 39.5% 3%
12 months.

NA 51.6% 4%
aDifference:
12.1% (95% confidence interval -23.1 to -1.0),
Costs to Health Service
p=0.033
In terms of costs, the PA mesh costs approximately
£14.32 more than the NA mesh, and these costs as
well as the costs of treating additional recurrences
Secondary End Points have been calculated in a United Kingdom context.
Given that about 70,000 inguinal hernias are re-
Return to normal activities was the same in both paired each year, this translates to a cost of about
groups (⊡ Table 38.3). There were six (3.7%) wound £1.4 million to the United Kingdom health service.
infections in the PA group and 10 (6.3%) in the NA This will increase to £6.4 million when the cost of
group. Hernia recurrence was significantly more treating the extra recurrences is factored in.
284 Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy Groin Pain?

⊡ Table 38.3. Time to normal activities in days; values are median (interquartile range)

PA group NA group p-value (log rank test)

Paid work 21 (14–42), n=82 26 (10–49), n=77 0.375

Housework 10 (5–24), n=161 10 (4–21), n=154 0.579

Social life 10 (5–21), n=161 10 (4–24), n=154 0.622

Sex 28 (14 to >365), n=161 28 (14 to >365), n=154 0.649

Hobbies 20 (10–40), n=161 14 (7–31), n=154 0.283

⊡ Table 38.4. Hernia recurrence at 12 months in the partially absorbable (PA) and nonabsorbable (NA) groups

Number Recurrencea p (Fisher’s exact test)

PA 142 8 (5.6%) 0.037

NA 142 1 (0.7%)
aAnalysis performed with respect to those who completed the postoperative assessments

Discussion pylene mesh, underestimated the consequence of


inadequate fixation with Vypro II. This may ex-
This study shows that there was no difference in plain why most of the recurrences–five of eight–
pain scores at rest or with movement between were observed in one of the participating centres.
patients randomised to PA or to NA mesh. There Surgeons in this centre admitted that they did not
was also no difference in severe pain between the adhere to taking suture bites of at least 1 cm with
two groups. It is likely that the small differences in the PA mesh.
all types of pain reported in favour of the PA group The PA mesh used in this study was among
reflected differences in mild and very mild pain the first of its type to be investigated in a ran-
in this study. This finding is in keeping with other domised clinical trial. The perceived advantage
studies in which patients were less likely to feel a of leaving about one-third of the amount of poly-
foreign body in their groin after inguinal hernia propylene in situ after the polyglactin compo-
repair with Vypro mesh [4]. nent is absorbed has been exploited in other
One of the disappointing results of this study products that maintain the tensile strength of
was a significant increase in recurrence rates in the absorbable component for a longer period
the PA group. Subsequent investigation revealed (e.g. Ultrapro [7]). These products may perform
that the reason for this was that the suture pull- better than Vypro II but need to be evaluated in
out force in the knitted direction of the mesh a similar fashion. Meshes with less polypropyl-
38 was low (⊡ Fig. 38.4). This may have caused or ene and a larger pore size, 3–4 mm, should also
contributed to the high recurrence rate in the be evaluated in randomised clinical trials. The
PA group. The manufacturer had stressed that in vitro performance of these products may not
suture bites of at least 1 cm were required with be matched by what happens in patients. New
its product. Surgeons used to taking smaller bites products, such as polyvinylidene fluoride, that
of mesh, as is routine with conventional polypro- have a similar weight to conventional polypro-
Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy
285 38

⊡ Fig. 38.4. Suture pull-out force

pylene meshes but a larger pore size also require ferent products in larger multicentre controlled
further careful evaluation in long-term follow-up clinical trials.
studies [8]. Biological products that are thought
to help stimulate growth of normal human blood
vessels and collagen have also had limited testing References
in inguinal hernia repair [6].
One of the drawbacks of the many new prod- 1. Bay-Neilson M, Perkins FM, Kehlet H. Pain and functional
impairment 1 year after inguinal herniorrhaphy: a nati-
ucts is the increased costs. Some of these products
onwide questionnaire study. Ann Surg 2001; 233:1–7
are several times more expensive than conven- 2. MRC Laparoscopic Groin Hernia Trial Group. Laparoscopic
tional polypropylene meshes. It follows, there- versus open repair of groin hernia, a randomised compa-
fore, that a dramatic improvement in the patients’ rison. Lancet 1999; 354:185–190
quality of life, with similar or reduced recurrence 3. Lagenbach MR, Schmidt J, Zirngibl H. Comparison of
biomaterials in the early postoperative period. Polypro-
rates, would be required to justify their routine
lene meshes in laparoscopic inguinal hernia repair. Surg
use in inguinal hernia repair. While this seems Endosc 2003; 17:1105–1109
unlikely, the cost to the health service of a product 4. Post S, Weiss B, Willer M, Neufang T, Lorenz D. Ran-
would be reduced if proven advantages resulted in domised clinical trial of lightweight composite mesh
increased use. for Lichtenstein inguinal hernia repair. Br J Surg 2004;
91:44–48
This study demonstrates no clinical advantage
5. Junge K, Klinge U, Rosch R, Klosterhalfen B, Schumpelick
for using a PA mesh in inguinal hernia repair. The V. Functional and morphological properties of a modi-
significant reduction in mild discomfort that was fied mesh for inguinal hernia repair. World J Surg 2002;
observed warrants further investigation with dif- 26:1472–1480
286 Chapter 38 · Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy Groin Pain?

6. Lichtenstein IL, Shulman AG, Amid PK, Willis PA. Hernia had mistakes here, and we have to make more
repair with polypropylene mesh, an improved method. overlap. The question to Bringman was that with-
AORN J 1990; 52:559–565
out enough overlap at the pubic bone, we have
7. Cobb WS, Kercher KW, Heniford BT. The argument for
lightweight polypropylene mesh in hernia repair. Surg problems. We need an optimized technique for
Innov 2005; 12:63–69 these new meshes.
8. Klinge U. Mesh for hernia repair. Br J Surg 2008; 95:539– O’Dwyer: We need a product that is forgiving.
540 Simons: How can there be 60 randomized in one
group and only 48 in the other?
What kind of randomization system did you have?
Discussion O’Dwyer: It was a computer-generated randomiza-
tion by our statisticians. Every single patient was
Montgomery: You mentioned the mesh weight, entered again as a new entry—it was not a block
and you said there was a middleweight mesh of randomization.
85 g. I just wondered whether this group here has
a consensus on what is a lightweight mesh and
what a heavyweight mesh. Should we use or call
anything midweight meshes?
O’Dwyer: Just out of interest, one of our group
has decided that less than 40 g/m2 is truly light-
weight and between 40 and 80 is middleweight,
and if it’s greater than 80 it is heavyweight. But
you could also say that if it is lighter than 60 g/
m2 it’s light weight, and if it’s greater than 60, it is
heavyweight.
Montgomery: Is anyone here having sort of a
consensus on this topic? And should we count the
mesh weight together with the composite part of
it?
Hegarty: We have to distinguish between mesh
weight and pore size, don’t we? I am not bothered
about how much it weighs or about the diameter of
the filaments—I want a big-pore mesh.
Conze: I think it is not only the weight—forget
about the weight. There are meshes that are cer-
tainly more heavy than polypropylene. Say, PVDF
is more heavy. If you take a PVDF mesh with the
same size and the same pore size as a polypropyl-
ene mesh, it is going to be a heavyweight mesh. We
should focus more on pore size and even more on
surface area. And by doing that, we will get to a
new classification.
O’Dwyer: I think that makes sense. Pore size and
38 filament type are perhaps more important. Unfor-
tunately, we have gone down this route for the last
10 years.
Schumpelick: The question is if we need a new
technique for these lightweight flexible meshes.
We have learned that with the ventral hernia we
39

New Understanding of the


Causes and Surgical Treatment
of Postherniorrhaphy Inguinodynia
and Orchialgia
P. K. Amid
288 Chapter 39 · New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy Inguinodynia

Introduction than dividing the nerve as it emerges from the


internal oblique muscle, as was our practice previ-
Advances in inguinal hernia repair, such as the use ously, the nerve was followed and severed proxi-
of prosthetic materials and new techniques, have mal to the surgical field of the original hernia
markedly reduced the postherniorrhaphy recur- repair. In 21 of those patients, the intramuscular
rence rate. However, chronic pain after hernia segment of the iliohypogastric nerve was scarred
repair is of continuing concern. According to the by perineural fibrosis or entrapped by sutures
Swedish Hernia Registry, the incidence of chronic placed when the so-called conjoined tendon was
pain postherniorrhaphy is greater than that of her- sutured to the inguinal ligament, plug, or flat
nia recurrence [1]. We have previously described mesh, depending on the method of the original
the causes, prevention, and surgical treatment of hernia repair. In less than 5% of patients, the il-
postherniorrhaphy chronic pain [2]. iohypogastric nerve is under the internal oblique
The current study of groin neuroanatomy has aponeurosis in the inguinal region. During hernia
resulted in new understanding of certain features repair in these patients, the subaponeurotic course
of postherniorrhaphy inguinodynia and orchialgia. of the nerve must be determined by noting the
Our series now stands at 465 patients who have
undergone operation for chronic post hernia repair
groin pain intractable to nonsurgical pain manage-
ment treatment. Recent observations of groin neu-
roanatomy have prompted a modification of our
neurectomy technique to include a more extensive
resection of the iliohypogastric nerve and, for pa-
tients with orchialgia, resection of nerves within
the lamina propria of the vas deferens as well.
These observations also illustrate methods to avoid
nerve injuries in the original hernia operation.

Methods
⊡ Fig. 39.1. Intramuscular segment of the iliohypogastric
Between 1995 and 2008, the triple neurectomy nerve exposed by splitting the muscle fibers (with sutures
operation was performed on 465 patients who retracting the edges of split)
did not respond to nonsurgical pain management
treatment. These patients either did not have pain
prior to their original hernia repair or, if they
did, their postoperative pain was different from
their preoperative pain and had the characteristic
features of neuropathic pain according to the In-
ternational Association for the Study of Pain. The
interval between the original hernia repair and
triple neurectomy was 2–5 years. In 210 patients
who underwent triple neurectomy from 2004 to
2008, attention was focused on the intramuscular
segment of the iliohypogastric nerve, the most vul-
39 nerable neural structure within the operative field.
A slit was made in the internal oblique muscle ⊡ Fig. 39.2. Point of simultaneous passage of a subaponeu-
fibers to expose the intramuscular segment of the rotic iliohypogastric nerve from both external and internal
iliohypogastric nerve (⊡ Fig. 39.1). Then, rather oblique aponeurosis
Chapter 39 · New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy
289 39
location of its exit at the small point of attach-
ment between the internal and external oblique
aponeuroses (⊡ Fig. 39.2), and the surgeon should
avoid placing sutures or staples below the above-
mentioned point because the course of the nerve
under the internal oblique aponeurosis is inferior
and lateral (⊡ Fig. 39.3). During triple neurectomy,
the subaponeurotic iliohypogastric nerve can be
identified by splitting the internal oblique aponeu-
rosis immediately below the aforementioned point
(⊡ Fig. 39.3).
In early 2005, a patient was referred with
chronic groin pain and orchialgia, and a magnetic
⊡ Fig. 39.3. Subaponeurotic iliohypogastric nerve exposed by
resonance scan showed the vas deferens entrapped
splitting the internal oblique aponeurosis
by a plug (⊡ Fig. 39.4). At operation, the plug com-
pletely encircled the vas deferens (⊡ Fig. 39.5). Be-
cause the patient had undergone an earlier va-
sectomy, the entrapped segment of the vas was
resected during the triple neurectomy. Postopera-
tively, the patient’s groin pain and orchialgia disap-
peared, which was contrary to our experience with
other patients with both groin pain and orchialgia
who had undergone triple neurectomy alone. His-
tological study showed fibrosis and foreign body
reaction around the paravasal nerves within the
lamina propria of the vas (⊡ Fig. 39.6).
In 11 subsequent patients with groin pain and
orchialgia combined, a 2-cm segment of the lamina
propria of the vas was resected (without resecting
the vas) as proximal to the internal ring as pos-
sible. Histology showed perineural fibrosis in these ⊡ Fig. 39.4. Magnetic resonance image showing entrapment
patients as well. of vas deferens by a plug

Results

From 1995 to 2008, 460 patients with chronic


postherniorrhaphy pain underwent surgical treat-
ment at the Lichtenstein Hernia Institute in Santa
Monica, California. In 180 patients who had most
recently undergone triple neurectomy, particular
attention was paid to the intramuscular portion
of the iliohypogastric nerve. Adding resection of
the intramuscular segment of the iliohypogastric
nerve improved the success rate of triple neurec-
tomy compared with division of the iliohypogas-
tric nerve at the point of its emergence from ⊡ Fig. 39.5. Explanted plug along with the entrapped seg-
the internal oblique muscle. Furthermore, adding ment of vas from Fig. 39.4
290 Chapter 39 · New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy Inguinodynia

⊡ Fig. 39.6. Perineural fibrosis of paravasal nerves corresponding to Figs. 39.4 and 39.5

resection of the lamina propria of the vas to triple neurectomy. Although a firm conclusion should
neurectomy eliminated testicular pain. not be drawn from such a small number of cases,
it seems that resection of the paravasal nerves is a
useful addition to triple neurectomy for patients
Discussion with orchialgia associated with inguinodynia.
Pain after placement of mesh in the parietal
The definition of chronic inguinodynia, its diag- compartment of the preperitoneal space (during
nostic criteria, preoperative workup, and intraop- both open and laparoscopic hernia repair) presents
erative verification, as well as the surgical treatment special problems. The main trunk of the gen-
and postoperative follow-up, have been described itofemoral nerve, the preperitoneal segment of its
previously [2]. Triple neurectomy is a proven sur- genital branch, and its femoral branch located
gical treatment for chronic postherniorrhaphy in the parietal compartment of the preperitoneal
pain that is intractable to multidisciplinary pain space have no fascial coverage to protect them
management. According to three major series, the from direct contact with nerves. This is in contrast
success rate of the operation ranges from 80% [3] to the nerves in front of the transversalis fascia,
39 to 95% [2, 4]. Resecting the intramuscular portion where the ilioinguinal and iliohypogastric nerves
of the iliohypogastric nerve, instead of severing the are covered by the investing fascia of the internal
nerve at the point of its emergence from the inter- oblique muscle, and the inguinal segment of the
nal oblique muscle, improves the outcome of triple genital branch is covered by the deep cremasteric
Chapter 39 · New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy
291 39
fascia. These covering layers protect the nerves Failing to identify and protect the nerves during
by acting as a barrier against the mesh. There is hernia repair significantly increases the incidence
experimental evidence that direct contact of mesh of postherniorrhaphy pain [6–8]. Yet this issue
with the nerves leads to certain ultrastructural has not received due attention. According to the
changes in the nerves; this evidence is consistent Netherlands Hernia Registry, only 32% of surgeons
with the preliminary results of our ongoing study identified the iliohypogastric nerve during hernia
of the structural changes of nerves in patients repair, and only 36% identified the genital branch
suffering from postherniorrhaphy pain. Also, be- of the genitofemoral nerves. As has been reported
cause the nerves within the preperitoneal space are by many authors [9], identification and careful at-
not easily accessible during operative exploration, tention to the groin nerves during hernia repair re-
surgical treatment of inguinodynia and orchial- duce the incidence of chronic pain to less than 1%.
gia after preperitoneal hernia repair is less likely
to improve the patient’s symptoms. Therefore, we
reserve triple neurectomy for pain after laparo- References
scopic hernia repair for patients in whom staples
or tacks were used and for those in whom com- 1. Franneby U, Sandblom G, Nordin O, Gunnarsson U (2006)
Risk factors for long-term pain after hernia surgery. Ann
puted tomography or magnetic resonance imaging
Surg 244:212–219
shows meshoma. Recently we proposed a possible 2. Amid PK (2004) Causes, prevention, and surgical treat-
treatment for neuropathy following open and lap- ment of postherniorrhaphy neuropathic inguinodynia:
aroscopic preperitoneal repair by transabdominal triple neurectomy with proximal end implantation. Her-
retroperitoneal transection of periinguinal nerves nia 8:343–349
3. Madura JA, Copper CM, Worth RM (2005) Inguinal neurec-
over the psoas muscle [5]. This approach, which
tomy for inguinal nerve entrapment: an experience with
can be referred to as transabdominal retroperito- 100 patients. Am J Surg 189:283–287
neal triple neurectomy, is currently used for lap- 4. Starling JR, Harms BA (1994) Ilioinguinal, iliohypogastric,
aroscopic aortic surgery. In light of these new find- and genitofemoral neuralgia. In: Bendavid R (ed) Pros-
ings, the following recommendations are added to theses and abdominal wall hernia. RG Landes, Austin, pp
351–356
those previously suggested for preventing posth-
5. Amid P, Hiatt JR (2008) Surgical anatomy of the preperito-
erniorrhaphy inguinodynia [2]: neal space. J Am Coll Surg 207:295
1. Avoid passing sutures through the internal 6. Alfieri S, Rotondi F, Di Giorgio A, et al. (2006) Influence
oblique muscle. of preservation versus division of ilioinguinal, iliohypo-
2. Avoid suturing the upper edge of the mesh to gastric, and genital nerves during mesh herniorrhaphy:
prospective multicentric study of chronic pain. Ann Surg
the internal oblique muscle during Lichten-
243:553–558
stein tension-free hernia repair. 7. Wijsmuller AR, van Veen RN, Bosch JL, Lange JFM, Klein-
3. Avoid mesh implantation in the parietal com- rensink GJ, Jeekle J, Lange JF (2007) Nerve management
partment of the preperitoneal space; within during open hernia repair. Br J Surg 94:17–22
the inguinal canal a layer of fascia acts as a 8. Aasvang EK, Mohl B, Bay-Nielson M, Kehlet H (2006) Pain
related sexual dysfunction after inguinal herniorrhaphy.
barrier between the nerves and the mesh, but
Pain122:258–263
in the parietal compartment of the preperi- 9. Kingsnorth AN, Bowley DMG, Porter C (2003) A prospec-
toneal space, there is no investing fascia to tive study of 1000 hernias: results of the Plymouth Hernia
protect the nerves from direct contact with the Service. Ann R Coll Surg Engl 85:18–22
mesh.
4. Avoid removing the cremasteric layer in order
to protect the inguinal segment of genital and Discussion
paravasal nerves from direct contact with the
mesh and thereby avoid postherniorrhaphy Klinge: Why do you believe that a proper fixation
inguinodynia, orchialgia, and the possibility can prevent the development of mesh shrinkage
of infertility due to direct contact between the or mesh migration or meshoma? We have seen so
mesh and the vas deferens. many meshes after some times, despite thousands
292 Chapter 39 · New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy Inguinodynia

of tacks. Why do you think that some sutures can


prevent this development?
Amid: You are right. This usually happens in the
preperitoneal space, because the fixation is not
complete and the surface is not completely smooth.
Very rarely you can see these meshomas in front of
the transversalis fascia. And maybe light meshes
could prevent that. I do not know. But theoreti-
cally, it makes sense to assume that light meshes,
by creating less fibrotic tissue, may prevent me-
shoma formation.
Kehlet: You have operated on 460 patients now.
Do you find these abnormalities every time you
operate? What is the specific indication for these
operations? Secondly, neurosurgeons have done
neurosurgery for chronic pain for many years—
always disappointing. What is the follow-up here?
What happens with time? Do you really think that
you have solved the problem in the long term?
Amid: First, I tell you about the follow-up: We see
these patients 1 week and 1 month after the op-
eration and then up to 6 months. We contact them
by phone, and that is the end of our follow-up. I
admit, this is not a complete follow-up. After the
last telephone conversation—and they tell us they
are satisfied—if their pain comes back or becomes
more, they would contact us. I agree, that is not
scientific enough.
How often we find these pathologies? Almost all of
the time! The least thing that we find is very dense
fibrotic tissue—histologically, perineural fibrosis.
Now we study the structural changes of the nerves.
Penkert: With your large experience in these cases,
I wonder that you have success in all cases. So, we
must estimate preoperatively what kind of pain it
is. If it is neuroma pain, it works. But if it really is a
neuropathic pain, it is quite another thing. I am in
doubt. That is my comment.
Amid: The best indication for this operation is
when the previous operation is an anterior repair
without manipulation of the preperitoneal space.
If the preperitoneal space is manipulated, even by
placement of a plug or by placement of a PHS or
by a preperitoneal repair, then the pain could be
39 related to the nerves in front of the transversalis
fascia or behind the transversalis fascia. And there
is no way to find out what part is belonging to the
front and what part belongs to behind.
40

Surgery for Chronic Inguinal Pain:


Neurectomy, Mesh Explantation,
or Both?
G. D. Arlt, U. Huhn, C.C. Kersten
294 Chapter 40 · Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both?

Introduction
⊡ Table 40.1. Results of neurectomy for chronic groin
pain after inguinal hernia repair
Chronic inguinal pain is a rare but severe compli-
cation of inguinal hernia repair, with a prevalence n Mesh Success Follow-up
of disabling pain from 3% to 9% (Kehlet et al. Stulz and 23 0 70% ?
2002, Aroori and Spence 2007). Its exact cause and Pfeiffer 1982
lack of evidence-based treatment path presents
Starling et al. 30 0 83% ?
problems in the effective management of this sur- 1987
gical complication. Most cases may be treated con-
servatively with repeated injections of cortisone Kennedy et 23 0 63% 36–144
al. 1994 months
and a local anesthetic for a permanent local nerve
block. About 70–80% of the patients respond to Bower et al. 15 0 80% 66
the infiltration therapy to the point of maximum 1996 months
tenderness (Aroori and Spence 2007, Palumbo et Skandalakis 6 0 100% ?
al. 2007). In the others, different treatment strate- 1996
gies have been proposed, such as analgesics and
Heise and 9 100% 56% 16
antidepressants, transcutaneous electrical neural
Starling 1998 months
stimulation, or recurrent surgery with neurolysis
and neurectomy with or without removal of the Amid 2004 225 100% 80% –
mesh. Although the necessity of repeated surgery
Madura et al. 100 27% 72% 1–60
for chronic pain after mesh repair may be rather 2005 months
low, at about 0.35% (Delikoukos et al. 2008), there
Ducic et al. 19 100% 84% 12
is major disagreement concerning both the selec-
2008 months
tion criteria for recurrent surgery and the type of
surgery itself.
Considering the chronic postherniorrhaphy
pain syndrome in detail, two types of pain can In cases of chronic pain after mesh repair
be distinguished: 1) neuropathic pain caused by which cannot be assigned to a distinct nerve, the
entrapment of the ilioinguinal, iliohypogastric, or considered surgical approach is mesh removal with
genital branch of the genitofemoral nerve, and 2) or without additional neurectomy. Two small se-
nonneuropathic pain, which might be triggered by ries of mesh removal for pain after groin hernia
staples to the periosteum and/or compression and surgery have been published. In 1998 Heise and
scar formation around the implanted mesh materi- Starling described transinguinal mesh removal in
als. The latter type of pain may be further differ- 20 patients with severe groin pain following Lich-
entiated into nociceptive or somatic pain induced, tenstein or laparoscopic mesh repair. The outcome
for example, by staples, and visceral pain such as was excellent or good in 12 (60%) of the 20 cases.
dysejaculation or testicular pain (Loos et al. 2007, Aside from a tendency to see better results after
Kehlet 2008). additional neurectomy during mesh removal, they
In patients with neuropathic pain, a surgical were unable to identify other factors that could im-
approach with neurectomy of the involved nerves prove postoperative results or help select better pa-
seems rational. Several studies have been published tients for surgery (Heise and Starling 1998). Rosen
reporting the results of dual or triple neurectomy et al. presented their experience with mesh explan-
for chronic groin pain following inguinal hernia tation on the basis of 10 cases selected from 1998
surgery. Success rates vary from about 60% to 80% to 2004. The indication was chronic groin pain
in most series (⊡ Table 40.1). Unfortunately, several not responding to local anesthesia of the inguinal
of these studies are judged to be of poor quality nerves. The index operation was a Lichtenstein
due to nonstandardized selection criteria, short procedure in nine of the 10 cases. In contrast to
40 follow-up, and small sample sizes. Heise and Starling, they used a combined surgical
Chapter 40 · Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both?
295 40
procedure with transinguinal removal of the mesh mesh procedure had been done in 29 patients, and
and laparoscopic repair of the hernia defect. Re- 25 had had a mesh repair.
sults were good or excellent in nine of 10 patients The nonneuropathic pain group consisted of
(Rosen et al. 2006). 33 patients (26 male, seven female) with an average
Our own experiences with indications, opera- age of 48 (range 14–71) years. They were offered
tive technique, and results of revision surgery for a mesh removal procedure. The mesh procedures
chronic groin pain after inguinal hernia repair are done previously were a transabdominal preperito-
presented here. neal or totally extraperitoneal repair in 23 patients,
a Lichtenstein repair in five, and a mesh-plug re-
pair in another five cases.
Patients and Methods Several attempts at conservative treatment on
an outpatient basis had been made for all of the pa-
Patient Selection tients. In some cases, psychosomatic therapy had
been recommended. Patients with mild or moder-
Patients with persistent or recurrent disabling pain ate symptoms responding to conservative therapy
interfering with daily activities 3 months after the were not included in this series.
index operation were judged as chronic pain cases.
Pain of other origin, including hernia recurrence,
was ruled out by pain history, clinical and ultra- Operative Technique
sound examination, and, in some cases, magnetic
resonance imaging. Initial treatment was conserva- In patients dedicated for neurectomy, the lateral
tive and consisted of oral analgesics and infiltra- part of the skin scar in the groin was opened and
tion therapy with local anesthetics and steroids. the deep inguinal ring exposed. After exclusion of
Those who did not respond to this treatment were a recurrent hernia, the ilioinguinal and iliohypo-
candidates for surgery. Patients with neuropathic gastric nerves were identified lateral to the deep
pain responding to diagnostic nerve block with ring. Both nerves were resected, and a 1-cm strip
local anesthetics (10 ml of Xylocaine 1% at the of nerve tissue was harvested for histologic ex-
anterior superior iliac spine) were offered revision amination. The proximal ends of the nerves were
surgery with dual or triple neurectomy. Those with embedded in the internus muscle. In cases with
nonneuropathic pain exhibiting no significant pain triple neurectomy, the genital branch of the gen-
relief after nerve block were candidates for mesh itofemoral nerve was identified at the »blue line«
removal and neurectomy. near the deep ring and was resected together with
the external spermatic vessels. The surgical tech-
nique of mesh removal has been described before
Patients (Arlt et al. 2003).

From October 1998 to December 2007, 87 patients


with chronic groin pain not responding to conser- Perioperative Care and Follow-Up
vative treatment were referred for further surgery
at the surgical department of the Park-Clinic in Informed consent was given by all patients regard-
Berlin-Weissensee, Germany. ing an increased risk of intraoperative and post-
Fifty-four patients with severe neuropathic operative complications (estimated percentage of
complaints following an inguinal hernia repair ischemic orchitis about 5%, vascular injury about
were identified for recurrent surgery with double 5%, and recurrent hernia up to 10%). A single-shot
or triple neurectomy: 34 men and 20 women with antibiotic prophylaxis was used in all operations.
an average age of 47 (range 14–77) years. Thirty- All patients were mobilized within 4–6 h postop-
one cases presented after primary repair, and 23 eratively. Patients were discharged according to
patients had had several hernia repairs. A non- their own wishes between days 2 and 10. Physical
296 Chapter 40 · Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both?

activity was restricted for 2 weeks after hospital sified as having a fair result. In seven cases, the
discharge. pain persisted or returned within 6 months after
All patients were followed for at least 6 months the operation.
postoperatively. The last follow-up examinations Detailed analysis of the cases with intermittent
with clinical assessment and ultrasound were done or persisting pain showed that an adverse outcome
in June 2008, with the follow-up interval ranging (fair or bad) was more likely in younger patients
from 6 to 86 months. Results were classified as and those who had repair for a recurrent hernia
good for satisfied patients with complete pain re- (⊡ Table 40.2). Further surgery with a triple neurec-
lief and no need for further analgesic medications. tomy or a secondary mesh removal was done in
Satisfied patients with some pain during physical six patients. Consideration of the risk of further
activity and the need for painkillers on demand surgery with mesh removal in patients with neu-
not more than once or twice a week were classified ropathic pain and a mesh repair in their history
as having a fair result. A bad outcome was quoted showed a 20% risk for additional operations in this
in dissatisfied cases with persisting or recurrent subgroup (five of 25 cases).
disabling pain after the revision surgery.

Mesh Removal
Results
In the group receiving mesh removal, complete
Neurectomy or near total explantation of the foreign body was
achieved in 32 of 33 patients. In one man with a
In the group having neurectomy surgery, no se- previous Lichtenstein repair, the mesh removal was
vere intraoperative or postoperative complications impossible due to extended scar formation at the
occurred. All 54 patients could be followed at cord, indicating a high risk for testicular atrophy.
least 6 months postoperatively. Forty-two patients The surgery was restricted to a dual neurectomy
showed a good result with no complaints and no with a fair result 6 months after the operation.
analgesic medication at the follow-up examina- In the other 32 patients, one case each of par-
tion after 6 months. Another five patients were tial resection of the bladder, resection of the small
also satisfied with the surgery but reported in- bowel, suture of the femoral vein, seroma forma-
termittent pain during physical activity requiring tion, and ischemic orchitis with testicular atrophy
analgesics once or twice a week. They were clas- were the major intraoperative and postoperative
complications. Reconstruction of the posterior
wall was done with a two-layer Shouldice proce-
dure in 25 cases and a Lichtenstein repair using a
⊡ Table 40.2. Results of neurectomy in 54 patients lightweight mesh (Vypro II /Ultrapro) in six cases.
with neuropathic pain; cases with intermittent or per- In a 57-year-old woman, the excision of the mesh–
sisting pain (fair or bad results of surgery) were sum-
fascia–muscle specimen resulted in a large defect
marized as nonresponders
of the posterior wall, which had to be closed by a
Nonresponders 12/54 (22%) Rives procedure with a Vypro II mesh.
Macroscopically, all mesh specimens showed
After primary repair 3/31 (10%)
extended folding and shrinkage of 50–70% of
After recurrent repair 7/25 (28%) the surface (⊡ Figs. 40.1 and 40.2). Analysis of the
Age >50 years 3/25 (12%) mesh material and the histopathologic examina-
tion of the explanted foreign bodies showed that
Age <50 years 7/29 (24%) 30 meshes were heavyweight (>90 g/m2) polypro-
Further surgery 6/54 (11%) pylene meshes and two were polyester meshes.
Chronic inflammation and apoptosis were regular
40 Secondary mesh removal 5/25 (2%)
findings at the mesh–tissue interface.
Chapter 40 · Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both?
297 40
At follow-up 6 months to a maximum of 86
months postoperatively, two recurrent inguinal
hernias were found. Twenty-two patients had no
complaints and were completely satisfied (69%
good results). In seven cases, the patients were
satisfied but had intermittent pain during physi-
cal activity (22% fair results). In one of these
patients, a recurrence was found and repaired.
During further follow-up, this patient again had
a fair outcome. Three patients were dissatisfied
(9% bad results). One developed a testicular atro-
phy, another a symptomatic recurrent hernia, and
another complained of persisting disabling pain
(⊡ Table 40.3).

Conclusion
⊡ Fig. 40.1. Polypropylene Hernia System prosthesis from a
17-year-old girl 11 months after implantation
The series of 87 patients surgically treated for
chronic postherniorrhaphy pain shows that a good
or fair clinical result with a satisfactory outcome
can be achieved in up to 85% of cases. An impor-
tant supposition is careful selection of patients.
Indication should be restricted to cases with con-
servatively intractable symptoms. At present, the
distinction between neuropathic and nonneuro-
pathic pain on the basis of local nerve blocks can
be recommended.
The mesh removal operation is challenging,
and the surgeon should also be experienced in her-
nia and vascular surgery. Informed consent from
the patient concerning the increased risk of tes-
ticular and vascular complications is necessary. To
⊡ Fig. 40.2. Heavyweight small-pore polypropylene prosthe-
develop a standardized surgical approach regard-
sis 18 months after a transabdominal preperitoneal repair
ing chronic groin pain after hernia repair, a large
multicenter study would be indispensable.

⊡ Table 40.3. Results of mesh removal for chronic


pain: follow-up at 6–86 months
References
Follow-up in June 2008 (clinical n=32
exam/ultrasound) Amid PK (2004) Causes, prevention, and surgical treatment
of postherniorrhaphy neuropathic inguinodynia: triple
Recurrent hernia n= 2
neurectomy with proximal end implantation. Hernia
No complaints/satisfied n=22 (69%) 8:343–349
Arlt G, Lamm T, Klosterhalfen B (2003) Mesh removal in ingui-
Pain during physical activity n=7 (22%) nal hernia repair. Eur Surg 35:42–44
Aroori S, Spence RA (2007) Chronic pain after hernia sur-
Dissatisfied (testicular atrophy/ n=3 (9%)
gery–an informed consent issue. Ulster Med J 76:136–
recurrence/persistent pain)
140
298 Chapter 40 · Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both?

Bower S, Moore BB, Weiss SM (1996) Neuralgia after inguinal your residents to just approximate the mesh to
hernia repair. Am Surg 62:664–667 whatever structure you are using, if you have the
Delikoukos S, Fafoulakis F, Christodoulidis G et al. (2008) Re-
poor luck of having a nerve in between, it is not
operation due to severe late-onset persisting groin pain
following anterior inguinal hernia repair with mesh. Her- going to be strangled, and the patient will not have
nia 12:593–595 pain. Because otherwise, going after those nerves
Ducic I, West J, Maxted W (2008) Management of chronic post- is difficult. Again, the technique is a very impor-
operative groin pain. Ann Plast Surg 60:294–298 tant aspect for having good results.
Heise CP, Starling JR (1998) Mesh inguinodynia: a new clinical
Schumpelick: I congratulate you. I think it is one
syndrome after inguinal herniorrhaphy? J Am Coll Surg
187:514–518 of the ugliest operations of all. You must inform
Kehlet H (2008) Chronic pain after groin hernia repair. Br J your patients about the loss of sensitivity, bleeding
Surg 95:135–136 of the vein, about the big hole you left and that
Kehlet H, Bay-Nielsen M, Kingsnorth A (2002) Chronic posth- you have to close maybe with a new mesh. And
erniorrhaphy pain–a call for uniform assessment. Hernia
you must give him the message that at least 20%
6:178–181
Kennedy EM, Harms BA, Starling JR (1994) Absence of mal- will have pain. If patients agree with that, he really
adaptive neuronal plasticity after genitofemoral-ilio- must have pain. Even in younger people. In my
inguinal neurectomy. Surgery 116:665–670; discussion personal experience, they will even come if you say
670–671 that they might lose their testes. We have at least
Loos MJA, Roumen RMH, Scheltinga MRM (2007) Classifying
once a month such a patient.
postherniorrhaphy pain syndromes following elective in-
guinal hernia repair. World J Surg 31:1760–1765 Champault: Two years ago, I saw a young man
Madura JA, Madura JA II, Copper CM, Worth RM (2005) Ingui- with pain. I explained the risk of infertility because
nal neurectomy for inguinal nerve entrapment: an experi- he had a hernia on the other side when he was
ence with 100 patients. Am J Surg 189(3):283–287 2 years old. So he said okay, and he came back
Palumbo P, Minicucci A, Nasti AG et al. (2007) Treatment for
2 weeks ago with a young boy. To sum up, he post-
persistent chronic neuralgia after inguinal hernioplasty.
Hernia 11:527–531 poned the operation for one girl and one boy.
Rosen MJ, Novitsky YM, Cobb WS, Kercher KW, Heniford BT Kehlet: Apparently you did a local anesthetic block
(2006) Combined open and laparoscopic approach to to divide your indication toward neurectomy or
chronic pain following open inguinal hernia repair. Her- mesh removal. What is the rationale for that, be-
nia 10:20–24
cause if you think the pain is coming from the
Skandalakis JE, Skandalakis LJ, Colborn GL (1996) Testicu-
lar atrophy and neuropathy in herniorrhaphy. Am Surg mesh, a local anesthetic block should also help?
62:775–782 Arlt: I do not believe that the pain always origi-
Starling JR, Harms BA, Schroeder ME, Eichman PL (1987) Di- nates from the mesh.
agnosis and treatment of genitofemoral and ilioinguinal Kehlet: Why did you remove it?
entrapment neuralgia. Surgery 102:581–586
Arlt: Only in those cases where they had a me-
Stulz P, Pfeiffer KM (1982) Peripheral nerve injuries resulting
from common surgical procedures in the lower portion of shoma, because when we started this series we
the abdomen. Arch Surg 117:324–327 followed strictly the idea of having responders to
local anesthesia [receive] nerve cutting and non-
responders [receive] mesh removal. We saw that
we had five patients with pain responding to local
Discussion anesthesia who had to have a third operation to
take out the meshoma.
Deysine: It is evident that these are sometimes Kehlet: But my question is, if you believe that the
true catastrophes, implying very difficult surgery. pain is coming from the mesh or the meshoma,
I am not surprised about the complications that why shouldn’t a good anesthetic block work?
you have. Referring to your paper and the paper of Arlt: Yes, it works, but only for some hours. It was
Dr. Amid, there is an alternative thing that we can a diagnostic local anesthesia. We also do this injec-
teach to our residents when we do this hernia sur- tion therapy, and we have at least 60–70% of pa-
gery: that you do not need to tie knots extremely tients we do not have to operate on. Thirty percent
40 hard so that you strangulate the tissue. If you teach come again and again, despite injection therapy.
41

Results of Tailored Therapy for Patients


with Chronic Inguinal Pain
M. Stumpf, D. Kämmer, U. Klinge
300 Chapter 41 · Results of Tailored Therapy for Patients with Chronic Inguinal Pain

The onset of chronic inguinal pain has been in-


41 creasing in recent years, but therapeutic options
for these patients remain unclear. Different meth-
ods apart from conservative management have
been described for dealing with this problem.
These options include local revision of the scar
and the inguinal nerves, with the next step being
retroperitoneal triple neurectomy. Patients with an
implanted mesh have the option to have the mesh
material explanted, but this can sometimes be a
rather difficult operation.
We analyzed patients treated surgically for
chronic inguinal pain in the surgical clinic of the
University of Aachen (Germany) between 2005 ⊡ Fig. 41.1. Retroperitoneal triple neurectomy
and 2008. Thirty-three of these patients were in-
cluded in the study. All patients had to fill out a
structured pain questionnaire (Deutscher Schmer-
zfragebogen). In addition, immunohistochemi-
cal investigations of explanted nerves and meshes
were done. Most patients had experienced com-
plaints for more than 2 years. Seventy-five percent
of patients with chronic inguinal pain had had a
mesh repair in the past, mainly Lichtenstein or a
laparoscopic procedure.
The aim of the study was to analyze which
patients would benefit from an operative approach ⊡ Fig. 41.2. Explanted mesh plug and flat mesh
and to learn whether it is possible to distinguish
between two types of chronic inguinal pain and
whether there are any clinical implications for the
therapeutic strategy. ⊡ Table 41.1. Results after different operations
For treatment, we chose three different types
Local Explan- Neurec-
of surgery: local revision of the scar and nerves, revision tation tomy
retroperitoneal triple neurectomy (⊡ Fig. 41.1), or
explantation of the mesh. The explanted meshes Pain-free 0% 50% 25%
were mainly heavyweight flat meshes and plugs Improvement 50% 25% 50%
(⊡ Fig. 41.2).
Persistent pain 50% 25% 25%
The best results were achieved for patients
treated by complete mesh explantation: 75% were
pain free or had real improvement in their pain.
No patient was pain free after local revision, and those in group 2 had persistent pain after opera-
50% had persistent pain (⊡ Table 41.1). tion.
We then hypothesized that two types of Seventy percent of the male patients improved,
chronic inguinal pain exist. Type I is not curable but only 55% of the female patients did. There were
with operative intervention, but type II will pos- no statistically significant differences between the
sibly benefit from operative intervention. There- two groups with regard to age, obesity, duration of
fore, a differentiation was made among the pa- pain, days of hospital stay, or number of previous
tients: Group 1 patients were pain free or had an operations (⊡ Table 41.2). Looking at the types of
improvement in their pain after operation, and explanted meshes, it is interesting that all patients
Chapter 41 · Results of Tailored Therapy for Patients with Chronic Inguinal Pain
301 41
Stumpf: We fix the hernia as well. It depends on
⊡ Table 41.2. Differences between patients who
improved after surgery and those with persistent pain the age of the patients. If you have a young patient
with comparable stable tissue we do a Shouldice
Improvement Persistent repair. But after a TAPP or TEP hernia repair you
Age 51.16±13.93 43.17±13.97 mainly have a large defect of the abdominal wall.
In those cases we usually use large pore and low
Obese 8 4
weight meshes to fix it again.
Duration of pain 25±19.4 45±51.5 Köckerling: How do exclude a recurrence? And do
(months) you use a diagnostic laparoscopy?
Days at hospital 12.9±14.2 11.42±6.5 Stumpf: We use the ultrasound in every patient
with inguinal pain. However at first we try to
Former 1.8±1.0 1.58±1.0 diagnose a recurrence clinically followed by an
operations (n)
ultrasound. In case of an experienced investigator
you can objectify a recurrence very exactly. A diag-
nostic laparoscopy was used in some cases, but we
didn’t use it routinely.
with plug repairs were pain free after mesh explan-
tation. Both groups showed significant differences
in the immunohistochemical expression of CD68
and matrix metallopeptidase 2 (MMP2) at the
nerve tissue, which may hint at existing differences
in the ultrastructure of the two types of patients.
In conclusion, patients receive only minor ben-
efits from local revision of the scar and inguinal
nerves. The best results, yielding a high number of
pain-free patients after the revision, were reached
after mesh explantation. All patients who under-
went plug removal were pain free.
There might be a correlation between the type
of patient and the benefit experienced; patients
who were pain free after their operation showed
differences in immunohistochemical markers com-
pared with the patients who did not benefit from
surgery. Further investigation will be necessary
to elucidate these interesting findings concerning
chronic inguinal pain after hernia surgery.

Discussion

Gryska: When you do an explantation, are not also


doing at least a partial neurectomy?
Stumpf: Indeed, if you are doing a reoperation fol-
lowing a Lichtenstein hernia repair to also remove
the ilioinguinal nerve while the mesh explantation if
the nerve wasn’t dissected while the first operation.
Gryska: What are you doing with the hernia after
explantation of the mesh?
IV

IV Risk for Adhesion

42 Adhesion as a Chronic Inflammatory Problem?


Risk for Adhesions, Migration, and Erosions? – 305

43 Biological Tissue Graft: Present Status – 317

44 IPOM Results of 344 Consecutive Patients with a


PVDF-Derived Prosthesis – 323

45 Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia


Repair: 14 Years of Patient Data Accrual – 331

46 Tissue Ingrowth, Adhesion, and Mesh Contraction – 345

47 Effect of Different Mesh Materials on Adhesion Forma-


tion – 353

48 Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh


Materials: An Updated Review of the Literature – 365

49 Porosity and Adhesion in an IPOM Model – 375

50 Benefit of Lightweight and/or Titanium Meshes? – 381

51 ePTFE Prostheses and Modifications – 393

52 The Role of Stem Cells in Abdominal Wall Repair – 401


42

Adhesion as a Chronic Inflammatory


Problem? Risk for Adhesions,
Migration, and Erosions?
M. Binnebösel, K. Junge, C. D. Klink, J. Serno, J. Otto, J. Conze, A. P. Öttinger,
V. Schumpelick
306 Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration, and Erosions?

Introduction well-vascularized proliferating tissue, indicating a


dynamic and persistent remodeling [8, 9]. Besides
Peritoneal adhesions are common and develop plasmin, plasminogen activator, and plasminogen
42 postoperatively in more than 90% of patients fol- activator inhibitor, other factors–including trans-
lowing abdominal surgery. Most adhesions are not forming growth factor beta, matrix metallopro-
symptomatic, however. Even years after surgery, teinases, tissue inhibitors of metalloproteinases,
adhesions can lead to undesirable outcomes such insulin-like growth factor 1, and platelet-derived
as small bowel obstruction, infertility, abdomi- growth factor–have been revealed to be important
nopelvic pain, and difficult reoperative procedures mediators involved in peritoneal healing, all inter-
[1–3]. In addition, adhesions have a substantial acting with each other (⊡ Fig. 42.1) [10]. Currently,
impact on the national health economy. In a cur- the impact of inflammatory stimulants–including
rent Swedish survey, the annual cost of adhesion- chemoattractants [interleukin (IL)-8, monocyte
related problems was estimated to be €39.9–59.5 chemotactic protein-1] and cytokines (tumor ne-
million, and the cost of inpatient readmissions was crosis factor alpha, IL-1β, IL-6)–as products of
almost equal to that for gastric cancer [4]. invaded polymorphonuclear granulocytes, mono-
The peritoneum is the largest serous mem- cytes, and leucocytes is increasingly discussed as
brane, with a surface of 2 m2. It covers the vis- an important factor in adhesiogenesis [1–13].
ceral organs (visceral peritoneum) and lines the The aim of the first study was to investigate
abdominal cavity (parietal peritoneum) [5]. The whether human peritoneal adhesions reveal in-
peritoneum is composed of a monolayer of me- flammatory activity and whether persistent ad-
sothelial cells of mesenchymal origin, resting on a hesions reflect a disturbed peritoneal cell dif-
continuous basement membrane supported by the ferentiation, proliferation, and migration. To test
submesothelium. The submesothelial layer consists this hypothesis, we focused on the appearance
of the extracellular matrix made up of different of macrophages (CD68), B-lymphocytes (CD20),
types of collagen, glycoproteins, glycosaminogly- and T-lymphocytes (CD45) as main representa-
cans, and proteoglycans [5]. Diffusion and resorp- tives of the cellular immune response. Further-
tion of fluid occur freely through the mesothelium more, we measured the occurrence of cycloox-
and submesothelial stroma. The luminal surface ygenase-2 (COX-2) as a pivotal component of
of mesothelial cells has numerous microvilli, in- inflammatory cell activity. Finally, we analyzed
creasing the peritoneal surface area up to 40 m2 the expression profiles of Notch-3, ß-catenin, and
for exchange between mesothelial cells and the c-myc as important mediators of cell differen-
peritoneal cavity. Overall, the peritoneum must be tiation, proliferation, and migration involved in
regarded as an organ that has a protective function wound healing.
for the contents of the abdominal cavity. The aim of the second study was to investi-
Peritoneal defects during surgical procedures gate the kinetics of peritoneal adhesions in a rat
result in a reduced supply of oxygen and nutrients model with special regard to the cellular immune
as well as an impaired ability to remove metabolic response [T-lymphocytes (CD3) and macrophages
byproducts [6]. Correspondingly, it has been sug- (CD68)], inflammatory cell activity (COX-2), and
gested that adhesions may act as vascular grafts cell differentiation, proliferation, and migration
between healthy organs and areas of ischemic tis- (ß-catenin and c-myc).
sue, reflecting the body’s attempt to overcome local
damage [7]. It is generally supposed that peritoneal
adhesions reflect a kind of modified regeneration Patients and Methods
of the peritoneal surface, initially as tender and
fibrinous bands that are transformed to inert scar Study I: Patient Information
tissue with fibroblasts and collagen bundles [1].
In accordance with Epstein et al. [8], we found Adhesions were prospectively collected from 40
human peritoneal adhesions to be highly cellular, patients undergoing laparotomy at the surgical
Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration
307 42

⊡ Fig. 42.1. Elementary steps and complementary factors involved in the adhesion formation process according to Duron [10]
(PA plasminogen activator; PAI plasminogen activator inhibitor; TGF transforming growth factor; FSP fibrin split products; MMP
matrix metalloproteinase; ECM extracellular matrix)

department of the RWTH Aachen University Study II: Animal Model and Surgical
Hospital, Germany. The study was approved by Procedure
the local ethics committee, and patients gave
written informed consent to participate in the The animal experiment was approved by the Ani-
trial. The clinical parameters acquired included mal Care and Use Review Committee of the Rus-
age, gender, diagnosis, and surgical and medical sian State Medical University, Moscow. All animals
history. Adhesion maturity was calculated from were housed in accordance with the requirements
the date of the last previous abdominal surgery, of the German Animal Protection Act. For the
according to Herrick et al. [14]. In each patient, experiment, 60 male Sprague–Dawley rats with a
one sample of 5–10 mm was excised from the mean body weight of 380 g were used. All ani-
visceral peritoneum close to the intestine, and mals were kept under standardized conditions:
another sample of 5–10 mm was excised from temperature 22–24°C, relative humidity 50–60%,
the parietal peritoneum distant from the perito- and 12 h of light following 12 h of darkness. The
neum. Tissue specimens were immediately fixed animals had free access to food and water. Food
in 4% paraformaldehyde and embedded in paraf- was withdrawn 12 h before and after surgery. All
fin wax. operations were carried out under general anesthe-
308 Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration, and Erosions?

sia and aseptic and sterile surgical conditions. The mary antibody 1:100 (Dako), and as secondary
surgical procedure (explantation of the adhesion antibody we used rabbit antimouse 1:300 (Dako).
tissue) was done at the Joint Institute for Surgical Cyclooxygenase-2 (COX-2) detection was carried
42 Research of the Russian State Medical Univer- out by a 1:100 rabbit monoclonal antibody from
sity in Moscow. After introduction by isoflurane, DCS (Hamburg, Germany), with microwave pre-
general anesthesia was achieved with a subcuta- treatment three times, citrate buffer pH 6, and goat
neous mixture of 0.3 mg/kg medetomidine and antirabbit 1:300 (Dako) as secondary antibody. For
100 mg/kg ketamine hydrochloride. The rats were Notch-3 staining, we used a 1:50 rabbit polyclonal
weighed, and their skin was shaved and disinfected antibody from Santa Cruz Biotechnology (Santa
with a polyvidone–iodine solution. The animals Cruz, CA, USA), with microwave pretreatment
were fixed in a supine position. Laparotomy was three times, citrate buffer pH 6, and goat antirabbit
performed by a 4-cm midline incision, and then a 1:500 (Dako) as secondary antibody. Beta-catenin
standardized peritoneal defect with a diameter of was analyzed by a ready-to-use rabbit polyclonal
2 cm at the cecal area was created. The abdominal antibody from Spring Bioscience (Pleasanton, CA,
wall and skin were separately closed with continu- USA) and goat antirabbit 1:500 (Dako) as second-
ous absorbable 4/0 polyglactin sutures (Vicryl). No ary antibody. Furthermore, c-myc expression was
additional antibiotic treatment was given before or investigated by a 1:50 rabbit polyclonal antibody
during the experimental setting. (Santa Cruz Biotechnology) and goat antirabbit
On postoperative days 3, 5, 14, 30, 60, and 1:500 (Dako) as secondary antibody.
90, 10 animals, respectively, were sacrificed and The expression of immunohistochemical pa-
weighed for morphological, histological, and im- rameters was classified by two independent,
munohistochemical observations. In each animal blinded observers using a semiquantitative im-
the developed adhesion tissue, including parietal munoreactivity score according to the method of
and visceral peritoneum, was explanted, and tis- Remmele and Stegner [15]. Intensity of staining
sue specimens were immediately fixed in 4% para- was scored as 0 (negative), 1 (weak), 2 (medium),
formaldehyde and embedded in paraffin wax. or 3 (intensive). The extent of staining was scored
as 0 (0%), 1 (1–20%), 2 (21–50%), 3 (51–80%), or
4 (81–100%), indicating the percentage of positive
Histological Assessment staining in adhesion tissue. Multiplication of the
intensity score (0–3) and the extent score (0–4) re-
Histological and immunohistochemical investiga- sulted in the immunoreactivity score, ranging be-
tions were done at the Surgical Department of the tween 0 and 12. Sections were examined by stan-
RWTH Aachen University Hospital, Germany, and dard light microscopy (Olympus BX51, Hamburg,
were performed on paraffin-embedded 3-μm sec- Germany). For each sample, six regions (×400,
tions using peroxidase-conjugated, affinity-isolated area 100×100 μm) were captured by a digital cam-
immunoglobulins. All sections were routinely era (Olympus C-3030, Hamburg, Germany).
stained with hematoxylin and eosin (H&E) and were
processed at the same time to reduce internal stain-
ing variations. Briefly, immunohistochemistry was Results
done subject to the avidin–biotin complex method
and according to the manufacturer’s instructions. Study I: Human Peritoneal Adhesion
Macrophages (CD68) were identified by a 1:50 Tissue
mouse monoclonal antibody from Dako (Glostrup,
Denmark), with microwave pretreatment three The mean patient age was 55±19 years, and 17
times, citrate buffer pH 6, and rabbit antimouse female and 23 male patients were included in the
1:300 (Dako) as secondary antibody. For the detec- study. Eighteen of the 40 patients had had one
tion of B-lymphocytes (CD20) and T-lymphocytes previous abdominal operation, and 22 patients had
(CD45, CD3), we used a mouse monoclonal pri- had two or more. The parameters measured were
Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration
309 42

a b

c d

⊡ Fig. 42.2. Immunohistochemical features of peritoneal adhesion specimens demonstrating specific nuclear staining for T-
lymphocytes (CD45) and macrophages (CD68). T-lymphocytes were evident in peritoneal adhesions younger than 12 months
(a) and even in adhesions older than 12 months (b) without significant differences. Views c and d illustrate the specific nuclear
staining of macrophages (CD68), with significantly higher expression in adhesions <12 months (c) compared with adhesions
>12 months (d). (Magnification ×400)

not significantly affected by the gender or age of the rophages) compared with adhesions >12 months
patients or by the number of previous operations. (p<0.05). The expression of CD45 revealed no sig-
nificant differences regarding adhesion maturity
T-lymphocytes (CD45) and Macrophages (p>0.05). (See ⊡ Fig. 42.2.)
(CD68)
Investigation of the H&E-stained sections revealed Analysis of COX-2, ß-catenin, c-myc,
extended infiltrates of mononuclear round cells. and Notch-3
Subtyping of these cells by CD68 and CD45 dis- COX-2 showed a positive cytoplasmic staining
played predominant macrophages and T-lympho- with a mean score of 3±2.4. Similarly, ß-catenin
cytes. They were colocalized within the entire spec- was expressed in the cytoplasm of endothelial
imen, and the appearance of these cells correlated cells of blood vessels and fibroblasts (mean score
significantly with each other (r=0.624, p<0.001). 3.5±1.9). C-myc (mean score 3.1±1.8) showed pos-
Adhesions with an age <12 months showed a sig- itive nuclear staining, both in mononuclear round
nificantly elevated expression level of CD68 (mac- cells and in fibroblasts predominantly surrounding
310 Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration, and Erosions?

42

a b c

d e f

⊡ Fig. 42.3. Immunohistochemical features representing protein expression levels in peritoneal adhesions. Expression of
Notch-3 (a), ß-catenin (b), and c-myc (c) in adhesions <12 months. Expression of Notch-3 (d), ß-catenin (e), and c-myc (f) in peri-
toneal adhesions >12 months. (Magnification ×400)

a b

⊡ Fig. 42.4. Percentage of CD3-positive-stained cells representing a continuous infiltration of macrophages in visceral (a) and
parietal (b) peritoneal adhesions
Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration
311 42

a b

⊡ Fig. 42.5. a Percentage of CD68-positive-stained cells demonstrating a significantly higher expression in visceral adhesions
on postoperative days 3 and 5. b A significantly higher infiltration of macrophages was measured in parietal adhesions on post-
operative days 60 and 90

blood vessels. Expression of Notch-3 (mean score with the parietal site. At postoperative days 60 and
6.3±3.4) was pronounced in all specimens. Posi- 90, significantly more macrophages were detect-
tive staining was detected in the nucleus as well as able in parietal adhesions compared with visceral
in the cytoplasm of both mononuclear round cells adhesions (⊡ Fig. 42.5).
and fibroblasts (⊡ Fig. 42.3).
Cyclooxygenase-2, ß-catenin, and c-myc
A significant expression of COX-2 was evident in all
Study II: Experimental Data adhesions, both at the parietal and visceral sites of
the adhesions even 90 days after the operation. Over
During the observation period, none of the rats the course of time, COX-2 was significantly reduced
died or exhibited signs of infection. All rats devel- from the 3rd to the 90th postoperative days. The
oped peritoneal adhesions. expression of COX-2 at the visceral site of the adhe-
sions was significantly higher on postoperative days
T-lymphocytes (CD3) and Macrophages 3, 5, and 14 compared with the parietal adhesion
(CD68) sites. The expression of COX-2 was significantly
Both at the parietal and the visceral sites of the elevated at the parietal site of the adhesions on post-
adhesions, T-lymphocytes could be detected. The operative days 30, 60, and 90 compared with the
expression profile of CD3 was stable even until the visceral site (⊡ Fig. 42.6). Both ß-catenin and c-myc
90th postoperative day. Neither over the course of were detected at the visceral site of the adhesions.
time nor when comparing the parietal to the vis- Over time, the expression profile of both param-
ceral site were significant differences seen regard- eters showed no significant differences even 90 days
ing the expression of CD3 (⊡ Fig. 42.4). Likewise, following the operative procedure (⊡ Fig. 42.7). At
macrophages were detectable until the 90th post- the parietal site of the adhesions, ß-catenin was evi-
operative day. At postoperative days 3 and 5, the dent without significant differences over the course
infiltration of macrophages was significantly ele- of time. However, c-myc was not detectable at the
vated at the visceral site of the adhesions compared parietal site (⊡ Fig. 42.7).
312 Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration, and Erosions?

42

a b

⊡ Fig. 42.6. Collectively, there was a continuously marked expression of COX-2 until the 90th postoperative day. a In visceral
adhesions, the expression was significantly higher on postoperative day 3, 5, and 14. b A significantly higher expression was
measured in parietal adhesions on postoperative days 30, 60, and 90

a b

⊡ Fig. 42.7. a Persistent expression of ß-catenin and its target c-myc in visceral adhesions. b A persistent expression of ß-catenin
was detected in parietal adhesions, although no expression of c-myc was found distant to the intestine

Discussion ological wound healing and with lack of infection,


a time-dependent termination of the inflammatory
Traumatic peritoneal defects are presumed to ini- activity and a transformation of transient perito-
tiate adhesion formation, whereas the causation neal adhesions into scar tissue has been suspected
of maintaining peritoneal adhesions has not been [20, 21]. Analysis of human peritoneal adhesions
previously revealed [16–19]. Analogous to physi- demonstrated that they were cell-rich, well-vascu-
Chapter 42 · Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration
313 42
larized, and innervated tissue. In a previous study in situ regeneration of the peritoneal surface [32].
we also found them to be high in adipose tissue, Notch-3, ß-catenin, and c-myc are well-known
fibroblasts, and mononuclear round cells such as mediators in cell signaling pathways of prolifera-
macrophages and T-lymphocytes, irrespective of tion and differentiation responses during normal
the adhesions’ maturity [3]. development and wound healing [33, 34]. Notch
In 2007 Hoshino et al. demonstrated that peri- proteins are single-pass transmembrane receptors,
toneal macrophages trigger the development of playing a critical role in control and cell-fate deci-
peritoneal adhesions via the chemokine receptor 8 sions during developmental processes [35]. Notch
(CCR8) and its target, the chemokine ligand 1 favors cell proliferation and opposing cell differen-
(CCL1) [22]. Concordantly, we detected mac- tiation and is closely connected to Wnt signaling.
rophages in long-lasting peritoneal adhesions both ß-catenin and its target c-myc are crucial media-
in a rat model and even in mature human peri- tors of Wnt signaling and are thereby involved in
toneal adhesions. The evidence of a significantly the regulation of cell growth, cell differentiation,
higher infiltration of macrophages in the early and tissue remodeling [36–39]. Activation of the
postoperative period supports the assumption that ß-catenin/c-myc pathway contributes to impaired
macrophages trigger the development of peritoneal healing by inhibiting cell migration and altering
adhesions. In quantity and quality, T-lymphocytes cell differentiation [40]. In accordance, a marked
were found to have no significant differences re- expression of Notch-3, ß-catenin, and c-myc could
garding adhesion maturity. Consequently, an on- be verified even in mature human peritoneal adhe-
going persistent inflammatory process with a func- sions, indicating disturbed differentiation, migra-
tional impact of T-lymphocytes or T-lymphocyte- tion, and proliferation of mesothelial cells. Like-
synthesized chemokines in maintaining peritoneal wise, ß-catenin and c-myc were detected in the
adhesion may be suspected. rat model of adhesion formation, confirming the
Cyclooxygenase-2 (COX-2) is a regulatory assumption of a disturbance in peritoneal wound
factor in the biosynthesis of prostanoids such as healing.
prostaglandins, prostacyclin, and thromboxanes In conclusion, peritoneal adhesions should be
[23–25]. COX-2 expression is induced by a variety regarded as a consequence of continuously mal-
of growth factors and cytokines, and the expres- functioning cell differentiation and proliferation
sion increases rapidly in response to inflamma- within a chronic inflammatory process. It remains
tory stimuli and tissue damage [26–30]. During unclear whether the chronic inflammatory process
physiological wound healing, expression of COX-2 or the malfunctioning differentiation/prolifera-
regularizes within weeks after injury [31]. Saed et tion is causative in adhesiogenesis. Influencing the
al. measured significantly higher levels of COX-2 individual inflammatory response to peritoneal
in vitro in adhesion fibroblasts compared with nor- trauma seems to be necessary to avoid or at least
mal peritoneal fibroblasts and assumed an altered reduce the formation of postoperative peritoneal
cell regulation in peritoneal wound healing [30]. adhesions.
In accordance with these findings, we detected an
expression of COX-2 in human peritoneal adhe-
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STKE 2006;2006(335):re4
hesions and whether there is a correlation to pain.
34. Rodewald HR. Making a Notch in the lymphocyte kit. Eur
J Immunol 2006;36(3):508–11 Binnebösel: In our investigation we found no cor-
35. Deregowski V, Gazzerro E, Priest L, Rydziel S, Canalis E. relation to pain. Interestingly, previous publica-
Notch 1 overexpression inhibits osteoblastogenesis by tions showed that the amount of adhesions will
suppressing Wnt/beta-catenin but not bone morpho- increase with the number of previous operations—
genetic protein signaling. J Biol Chem 2006;281(10):
but this was different in our investigation. At the
6203–10
36. Schneikert J, Behrens J. The canonical Wnt signalling
moment, it seems unpredictable.
pathway and its APC partner in colon cancer develop- Smeds: Do you think it is a mechanical traction
ment. Gut 2006; 56(3):417–25 of the peritoneum and the adhesion that promotes
37. Luu HH, Zhang R, Haydon RC, Rayburn E, Kang Q, Si W, the pain?
Park JK, Wang H, Peng Y, Jiang W, He TC. Wnt/beta-catenin Binnebösel: Yes, this is a possible explanation for
signaling pathway as a novel cancer drug target. Curr
Cancer Drug Targets 2004;4(8):653–71
the pain.
38. Dihlmann S, von Knebel DM. Wnt/beta-catenin-pathway Montgomery: Where did you get the biopsies? I
as a molecular target for future anti-cancer therapeutics. think it is difficult to get reproductive biopsies?
Int J Cancer 2005;113(4):515–24 Binnebösel: Yes, this is a limitation of our study,
39. Bhatia N, Spiegelman VS. Activation of Wnt/beta-catenin/ because we randomly took two biopsies in every
Tcf signaling in mouse skin carcinogenesis. Mol Carcinog
patient. It is very difficult to define macroscopi-
2005;42(4):213–21
40. Stojadinovic O, Brem H, Vouthounis C, Lee B, Fallon J, cally where it is best to take the biopsies.
Stallcup M, Merchant A, Galiano RD, Tomic-Canic M. Mo-
lecular pathogenesis of chronic wounds: the role of beta-
catenin and c-myc in the inhibition of epithelialization
and wound healing. Am J Pathol 2005;167(1):59–69

Discussion

Franz: Even on the surface of the skin, it is difficult


to define what a chronic wound is. One way is to
look at the fibroblasts. For example, what about the
fibroblast function?
Binnebösel: But how should we investigate the
function of the fibroblasts? We have not done it.
Of course, it is a very important subject, but when
we looked at these adhesions there was a small
amount of fibroblasts.
Franz: So when you said »cell-rich,« you mainly
meant inflammatory cells?
Binnebösel: Yes
Schumpelick: Is the adhesion story a one-way
story, or is there a way back to normal tissue?
Binnebösel: At the moment, we just do not know.
We do not know whether peritoneal adhesions are
a reaction of everybody, and we do not know why
in some patients adhesions dissolve and in some
patients they do not. And we have to find a solu-
tion for this problem.
43

Biological Tissue Graft: Present Status


C. Bellows
318 Chapter 43 · Biological Tissue Graft: Present Status

Overview of the Disease antibiotics and thereby ensures their long-term


survival and leads to chronic infection of the her-
Reconstruction of abdominal wall defects is a chal- nia wound [10]. The increased morbidity and costs
lenging problem that many surgeons face, not only associated with infected mesh are so dire that sur-
in the elective setting but also during emergency geons avoid placing permanent mesh in grossly in-
surgery. Deficiencies of the abdominal wall can fected fields. Moreover, surgeons are now avoiding
43 be acute or chronic in nature and can result from placing permanent mesh in clinical circumstances
trauma, cancer, infection, or hernia disease. In- in which the risk of infection is increased, such
cisional hernias are the most common cause of a as in patients with a prior wound infection. Pre-
chronic abdominal wall defect. Despite advances dictably, strategies to address these complications
in medical technology, treatment of these defects related to the implantation of synthetic materials
remains controversial. In fact, the repair of ab- are now the focus of intense research by hernia
dominal wall defects continues to be imperfect surgeons. An extensive search is ongoing for al-
and costly, resulting in serious, chronic healthcare ternative materials with which to not only achieve
problems. Current practice guidelines and medical tension-free repair of an abdominal wall defect in
evidence support the use of a permanent pros- a single-stage operation (especially in the setting
thetic mesh for the repair of hernias as a means to of a contaminated wound) but also to achieve a
reduce the risk of recurrent hernia. Patients who functional abdominal wall and a better quality of
are not repaired with mesh, either owing to clinical life for the patient after repair. This search has led
complications or by surgeon choice, have a much to an era of acellular biological tissue grafts (e.g.,
higher incidence of recurrent hernia compared derived from natural materials).
with patients who are repaired with mesh [1–3].
Consequently, multiple prosthetic meshes with
a variety of characteristics have been developed. Rationale and Indications for Using
However, no single material has gained universal Biological Tissue Grafts
acceptance or preference, and a number of compli-
cations have been associated with the use of these The art and science of using tissue grafts from ani-
permanent synthetic materials [4–8]. mal (xenogenic) and human (allogenic) sources for
Most synthetic mesh strengthens the abdomi- abdominal wall reconstruction is nascent. However,
nal wall by inciting an intense fibroplastic response during the past few years, several biological tissue
to form a strong scar-plate interface. Although this grafts have been introduced and are available for
works well, the inflammatory response incited by hernia repair. The rationale for using a biological
the plastic meshes can lead to potentially serious tissue graft for abdominal wall reconstruction is to
complications such as bowel fistulation, mesh con- avoid acute and chronic mesh infection, unwanted
traction, intraperitoneal adhesions, erosion into chronic inflammation, and scar tissue formation,
the abdominal viscera, a sensation of being able which occur frequently in response to permanent
to feel the mesh, and increased stiffness of the synthetic materials after implantation. The poten-
abdominal wall with loss of compliance. Addition- tial benefits of these new materials are extremely
ally, the U.S. Food and Drug Administration has attractive and include superior biocompatibility
received numerous reports of other complications (i.e., minimum inflammatory response), reduced
associated with mesh, including chronic pain and adhesion formation, early vascular ingrowth, and
infection [9]. Indeed, mesh infections are one of decreased risk of infection in contaminated or po-
the most commonly reported complications and tentially contaminated surgical fields.
represent a potential nightmare. An infection is From a pathophysiological viewpoint, there
traumatic for the patient and time-consuming to are two different indications for biological tissue
treat. Bacteria adhere avidly to the mesh polymers grafts: One is to repair an acute abdominal wall
and immediately lay down a biofilm, which pro- defect created by trauma, cancer, or infection, and
tects them from host immunological defenses and the other is to repair a chronic, progressive ab-
Chapter 43 · Biological Tissue Graft: Present Status
319 43
dominal wall defect (i.e., hernia disease) resulting believe that this chemical cross-linking leads to
from a presumed defective collagen metabolism nonincorporation and preclusion of immune cell
or impaired wound healing (such as in steroid us- penetration, making these grafts unable to par-
ers). Whereas acute wound defects can be repaired ticipate in normal tissue remodeling. Instead, im-
with a biological tissue graft as a scaffold to induce mune cells encapsulate the grafts, consistent with a
normal tissue regeneration, such an approach may foreign body response.
lead to an inadequate and weak scar in patients Based on the variety of tissue origins as well
with chronic abdominal wall defects after remod- as distinct processing and sterilization procedures,
eling is complete. However, as is the case with any experimental studies have demonstrated that cur-
new medical device or product introduced into rently available biological tissue grafts vary in per-
clinical practice, experience and time will ulti- formance characteristics, such as cellular response,
mately define the utility and limitations. strength, biodegradability, susceptibility to infec-
tion, and tendency to transmit diseases from donor
to recipient after implantation [13]. Therefore, the
Types of Biological Tissue Grafts: use of biological tissue grafts for treating hernia
Distinguishing Features disease needs to be considered on a product-by-
product basis as additional knowledge from clini-
Biological tissue grafts are rendered acellular cal trials and clinical experience accumulates.
through various methods of preservation and
fabrication and are offered as collagen-rich scaf-
folding that allows cellular ingrowth and tissue Biological Tissue Grafts: Clinical Data
remodeling and revascularization, thereby setting
the stage for an intact hernia repair. However, The first biological tissue graft was approved for
the specific manufacturing processes that yield soft tissue reconstruction in 1999. Since that time,
modified collagen matrices vary significantly from the number of different products and the use of
one product to another. Therefore, each product these materials in clinical practice have grown
can be classified according to the material source, rapidly for want of a better solution for difficult
type of tissue, presence or absence of collagen hernia repairs. Currently, over 13 biological tissue
cross-linking, decellularization methods, and ter- grafts are commercially available. However, after
minal sterilization methods. Currently, the dif- many years on the market, some biological graft
ferent donor species grafts, including human and materials have been the subject of dozens of peer-
animal (porcine, bovine), are made of one of three reviewed publications, whereas a number of other
types of tissue: dermis, small intestine, or peri- products have been reported on in few or no publi-
cardium. The various decellularization methods cations–clinical or preclinical–indexed in Medline.
include physical (dissection, agitation, sonication, For example, a recent Medline search revealed 33
pressure, freeze–thaw), chemical (detergents, ionic published articles on small intestinal submucosa
solutions, acid/bases), and enzymatic methods. grafts, 32 on acellular human dermis grafts, and
The various terminal sterilization methods include 13 on cross-linked porcine dermis grafts [14]. In-
gamma irradiation, ethylene oxide gas, and hydro- terestingly, most of this published experience with
gen peroxide plasma. A few materials also employ biological grafts is in clean field cases rather than
a chemical cross-linking method in the preser- in infected fields.
vation/processing of their collagen tissue grafts. Despite some encouraging early results, several
Experimental studies have demonstrated that col- clinical complications have been reported follow-
lagen cross-linked with glutaraldehyde imparts a ing the use of these biological materials to recon-
high degree of stability to the collagen against the struct abdominal wall defects, including degrada-
activity of the degrading enzyme, collagenase [11, tion, laxity, lack of integration, and recurrence.
12], thereby slowing or stopping the degradation Although the companies developing and market-
of the donor collagen. However, some investigators ing biological tissue grafts make various claims for
320 Chapter 43 · Biological Tissue Graft: Present Status

the superiority of their product over others, as of these data suggest that the use of biological tissue
this writing, there are no prospective, randomized grafts may not be justified unless primary wound
clinical trial data comparing one biological tissue closure can be achieved.
graft to another and no data demonstrating the
superiority of one particular biological tissue graft
over a synthetic graft. Summary and Conclusions
43 Despite this lack of data, there is growing con-
cern that not all biological tissue grafts perform Abdominal wall integrity may be lost after trauma,
uniformly after implantation in humans. Clini- infection, herniation, or surgical resection. The
cal data suggest that outcomes may be related in surgical repair of these abdominal wall defects has
part to the material source and the processing changed considerably over the last decades. Cur-
method of these different biological tissue grafts. rently, a wide variety of new implantable acellular
For example, a recent systematic review reported a biological tissue grafts have been developed and
failure rate of 8% at 19 months for small intestinal introduced into the clinical market for the repair
submucosa grafts when used for ventral hernia of tissue defects. The sudden and rapid emergence
repair [14]. By comparison, an aggregate failure of these grafts has provided surgeons with an im-
rate of 15% at 12 months was reported for non- portant new tool in their surgical armentarium
cross-linked acellular human dermis grafts and 8% for treating abdominal wall defects, especially in
at 15 months for cross-linked porcine dermis [14]. contaminated or infected surgical fields.
These results may also be related to the implant When the complexity of the patients and the
scenarios, the implantation technique, a relatively implant scenarios is taken into consideration, bio-
short duration of follow-up for many of these stud- logical grafts have demonstrated a good overall
ies, and underreporting of complications related success rate. However, at present the data from
to the use of these products. For example, it is well prospective trials and case series are limited, with
documented that using biological tissue grafts in mostly short-term follow-up of patients treated
infected fields results in significantly higher fail- with biological tissue grafts for abdominal wall
ure rates than when they are implanted in clean reconstruction. More clinical work is necessary to
fields. Not only do these patients tend to be more determine which patients would benefit the most
emergent or critically ill, but patients with infected from repair using a biological tissue graft. To date,
fields also present the additional factor of material the best clinical outcomes reported with biologi-
digestion by bacterial enzymes that may weaken a cal tissue grafts for abdominal wall reconstruction
biological graft. Importantly, there have been more occur in patients in the absence of gross infection
reports on acellular human dermis grafts used in and when the graft is used as a fascial reinforce-
infected fields compared with small intestinal sub- ment. However, these first-generation biological
mucosa grafts [14]. tissue grafts are far from ideal.
The techniques used are also very important The ideal biological tissue graft may take one of
in hernia repair outcomes, and implantation tech- a number of possible forms in the near future. The
niques appear to be especially important with bio- most economical and proficient graft would be
logical grafts. Currently, several publications have one derived from a plentiful source, thus making
reported on the use of acellular human dermal ma- it affordable. In addition, the ideal graft material
trix in hernia repair, suggesting that recurrences should have an adequate shelf life so that it can be
are highest (80%) when the product is used as a taken off the shelf and used immediately; it should
fascial bridge to repair the defect [15]. By com- be 100% biocompatible; and it should resist infec-
parison, when the same biological tissue graft is tion. Degradation and replacement of the graft
used to reinforce a primary reapproximation of the material by host tissue should ultimately occur in a
fascia, utilizing the component separation tech- manner that maintains or increases the strength of
nique, recurrence rates as low as 0–5% have been the abdominal wall repair. It may also be hypoth-
reported at 2-year follow-up [16]. Taken together, esized that the composition of an ideal biological
Chapter 43 · Biological Tissue Graft: Present Status
321 43
tissue graft is able to restore normal wound healing 6. Morris-Stiff GJ, Hughes LE. The outcomes of nonabsor-
in hernia formers and thereby strengthens the re- bable mesh placed within the abdominal cavity: literature
review and clinical experience. J Am Coll Surg 186:352–
sulting scar. No biological tissue graft has yet been
367 (1998)
shown to possess all of these ideal characteristics. 7. Welty G, Klinge U, Klosterhalfen B, Kasperk R, Schumpelick
There is increasing evidence that biological V. Functional impairment and complaints following incis-
tissue grafts will become more customized or in- ional hernia repair with different polypropylene meshes.
dividually tailored for specific needs. An animal Hernia 5:142–147 (2001)
8. Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze
can have its own tissues (such as myofibroblasts J, Schumelick V. Impact of polymer size on interface scar
or stem cells) harvested and seeded onto extracel- formation in a rat model. J Surg Res 103:208–214 (2002)
lular matrices prior to being transplanted back 9. Robinson TN, Clarke JH, Schoen J, Walsh MD. Major mesh
into its body. This approach primes or precondi- related complication following hernia repair: events re-
ported to the Food and Drug Administration. Surg En-
tions the biological tissue graft with the intended
dosc 19:1556–1566 (2005)
recipient animal’s own progenitor cells. Such an 10. Jansen B, Schumacher-Perdreau F, Peters G, Pulverer
approach could add to the overall effectiveness of a G. New aspects in the pathogenesis and prevention of
biological tissue graft, making it more resistant to polymer-associated foreign-body infections caused by
bacterial colonization and accelerating the deposi- coagulase-negative staphylococci. J Invest Surg 2:361–
380 (1989)
tion of collagen, which may more rapidly increase
11. Oliver RF, Grant RA, Cox RW, Hulme MJ, Mudie A. Histo-
the strength profile [17]. Strategies to accelerate logical studies of subcutaneous and peritoneal implants
neovascularization of transplanted biological tis- of trypsin prepared dermal collagen allografts in rats. Clin
sue grafts after implantation will facilitate their Orthop 115:291–302(1976)
engraftment through the early delivery of oxygen, 12. Oliver RF, Barker H, Cooke A, Grant RA. Dermal collagen
implants. Biomaterials 23:38–40 (1982)
nutrients, host immune cells, and antibiotics. The 13. Sandor M, Xu H, Connor J, Lombardi J, Harper JR, Sil-
preseeding of stem cells or progenitor cells into verman RP, McQuillan DJ. Host response to implanted
tissue grafts could also offer an advantage with porcine-derived biologic materials in a primate model
respect to the need for rapid revascularization, as of abdominal wall repair. Tissue Eng Part A 14:2021–231
these cells are resistant to low oxygen conditions. (2008)
14. Hiles M, Record Ritchie RD, Altizer AM. Are biologic grafts
All of these approaches to create a »designer extra- effective for hernia repair? A systematic review of the
cellular matrix« are within reach in the near future. literature. Surg Innov 16:26–37 (2009)
Perhaps such an approach will be called »smart 15. Jin J, Rosen MJ, Blatnik J, McGee MF, Williams CP, Marks J,
biological tissue grafts.« Ponsky J. Use of acellular dermal matrix for complicated
ventral hernia repair: does technique affect outcomes? J
Am Coll Surg 205:654–660 (2007)
16. Espinosa-de-los-Monteros A, de la Torre JI, Marrero I, An-
References drades P, Davis MR, Vásconez LO. Utilization of human
cadaveric acellular dermis for abdominal wall reconstruc-
1. Luijendijk RW, Hop WC, van den Tol MP, et al. A compari- tion. Ann Plast Surg 58:264–267 (2007)
son of suture repair with mesh repair for incisional hernia. 17. Lai JY, Chang PY, JN Lin. Body wall repair using small
N Engl J Med 343:392–398 (2000) intestinal submucosa seeded with cells. J Pediatr Surg
2. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaas- 38:1752–1755 (2003)
donk EG, Jeekel J. Long term follow-up of a randomized
controlled trial of suture versus mesh repair of incisional
hernia. Ann Surg 4:578–585 (2004)
3. Sanchez LJ, Bencini L, Moretti R. Recurrence after lapa- Discussion
roscopic ventral hernia repair: results and critical review.
Hernia 8:138–143 (2004)
4. Carbonell AM, Harold KL, Mahmutovic AJ et al. Local Read: This is an excellent paper. We need more of
injection for the treatment of suture site pain after these, and I think your suggestions are excellent.
laparoscopic ventral hernia repair. Am Surg 69:688–691
Falagas: I was impressed by the fact that there
(2003)
5. Leber GE, Garb JL, Alexander AI, Reed WP. Long term com-
are 13 FDA-approved biological grafts. If it were
plications associated with prosthetic repair of incisional a medication or drug, the FDA would need two
hernias. Arch Surg 133:378–382 (1998) randomized controlled trials with about 1,000 pa-
322 Chapter 43 · Biological Tissue Graft: Present Status

tients to show the usefulness of the new product. first introduction of the material in the early ’90s.
But for a biological graft—how does the FDA ap- Actually, there is an FDA Web site where volun-
prove them? There were no randomized controlled tarily reported complications with these biological
trials? tissue grafts are recorded in a database. And the
Bellows: It takes a couple of animal experiments number one graft that has the most reported com-
to show that the material is safe, not carcinoge- plications was actually Permacol.
43 netic….Alloderm gets away with it because it is Schumpelick: There was a big difference with re-
a minimally processed tissue. But there are some gard to laparoscopic or open surgery. Is it because
companies now that are taking proactive stents, the abdomen is a black box and we do not see the
and actually they are doing prospective random- results, or is it because of different milieus?
ized trials, comparing the biologics to the synthet- Bellows: I do not think we have the answer yet.
ics in humans—but they are also selling the prod- Most people are not using these products lap-
ucts at the same time. aroscopically. Often the data is very rare and the
Falagas: Would you like to see comparisons of follow-up is very short, so I cannot make any con-
these materials before approval, or are you okay clusions on this subject.
with a few animal experiments?
Bellows: Of course not. If the companies do not
have any data, I do not use such materials.
Ma: Two years ago in Suvretta I presented data
about biological meshes in inguinal hernia repair.
But afterwards I realized two problems: First, can
we use biological meshes if the patient has a col-
lagen deficiency or a family history or a recurrent
hernia? Second: What about the bowels, e.g., pa-
tients with FAP?
Bellows: To your first question, yes, that is some-
thing that we need to know—whether these meshes
are indicated in patients with collagen disorders.
We do not have enough data. The inguinal hernia
stuff is a small number of patients. Second, I think
it is an indication for a biologic tissue graft. It is an
individual decision for each patient, taking into ac-
count whether there might be a contamination or
reoperation. Again, we do not have all the answers.
That is why we need prospective trials with com-
parisons of the different materials.
Kukleta: Among those first 250 reports to the FDA
about adverse effects of artificial materials, there
are quite a few on SIS. The first paper, as I remem-
ber, of 46 cases implanted in humans led to such
chaos that they went back to the manufacturer and
asked what was wrong with it and if it is really true
that it can be used in humans. And now, all of a
sudden, everybody thinks that things are getting
better. Do you have any explanation?
Bellows: I know Surgisis had a lot of problems, as
you mentioned. And they went back to the draw-
ing board and performed different types since the
44

IPOM Results of 344 Consecutive


Patients with a PVDF-Derived Prosthesis
D. Berger, M. Bientzle
324 Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis

Introduction
⊡ Table 44.1. Demographic and surgical data of
patients with incisional hernias
Incisional hernias frequently occur after major ab-
dominal surgery [1, 2]. Today the repair should  Median age: 65 years (22–92)
 Median body mass index: 29 (17–58)
be based on mesh augmentation of the abdominal
 Median hernia size: 122.5 cm2 (2–420)
wall because suturing alone has proved to be inef-  Median mesh size: 600 cm2 (80–2,115)
fective [3–5]. Conventional techniques mainly use  Median operating time: 77.5 min (30–230)
meshes in an onlay or sublay position and some-  Median hospital stay: 8 days (2–36)
44 times intraperitoneally. The laparoscopic approach  Median follow-up: 24 months (6–48 in
251/297=84%)
is characterized by the intraperitoneal placement
of meshes and therefore requires a special kind
of mesh material. These meshes should provide
strong incorporation on one side and prevent ad- ⊡ Table 44.2. Demographic and surgical data of
hesions to visceral organs on the other side. patients with parastomal hernias
One approach is the use of a material that al-
 Median age: 69 years (54–92)
lows the production of a foil with a smooth and a  Median body mass index: 28 (18–57)
rough surface, such as expanded polytetrafluoro-  Median hernia size: 155 cm2 (12–400)
ethylene (ePTFE), which was used in most cases  Median mesh size: 825 cm2 (525–1,425)
of laparoscopic ventral hernia repair reported in  Median operating time: 115 min (65–230)
the literature [6]. Another possibility is to cover  Median hospital stay: 10 days (6–66)
 Median follow-up: 20 months (6–48 in 43/47=91%)
a mesh made of polyester or polypropylene with
a resorbable film that prevents adhesions [7, 8].
A third approach is represented by DynaMesh
IPOM, which is made of polyvinylidene fluoride were clinically examined after 1, 3, 6, and 12
(PVDF) containing polypropylene on the parietal months and yearly thereafter.
side. An inert material such as PVDF, which does
not induce adhesions to visceral organs, can be
applied as a real mesh structure, with large pores Surgical Technique
being a precondition of strong and rapid incorpo-
ration. The incorporation characteristics can be Patients were always treated in the supine position.
improved by adding a small amount of polypropyl- The pneumoperitoneum was established with a
ene on the parietal side [9, 10]. Veress needle in cases with an untouched upper
This prospective study included 297 consecu- quadrant. In all other cases, an open approach was
tive patients with incisional hernias and 47 patients preferred. Usually, three trocars in one flank and
with parastomal hernias treated laparoscopically. one trocar on the opposite side were introduced.
The primary targets were the evaluation of the re- Adhesiolysis was performed by sharp dissection
currence rate and mesh-related complications. without any energy-driven device. Bleeding control
was achieved by bipolar coagulation. Routinely, the
whole original incision was covered by the mesh. In
Patients, Materials, and Methods patients with upper midline incisions, the falciform
ligament was dissected, and the space of Retzius
Patients was opened as well in cases with lower midline in-
cisions. The mesh was fixed with six stay sutures at
Between May 2004 and January 2008, 297 unse- the corners and in the midline between the corners
lected patients with incisional hernias and 47 pa- in the longest extension. Furthermore, spiral tacks
tients with parastomal hernias were prospectively (Protack; Covidien, Mansfield, MA, USA) were
treated and followed. The demographic data are used every 3–4 cm. The overlap of the defect and
summarized in ⊡ Tables 44.1 and 44.2. The patients the whole original incision was at least 5 cm.
Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis
325 44
The parastomal hernias were repaired by the
⊡ Table 44.3. Clinical outcomes of laparoscopic repair
recently described sandwich technique [11]. Af- of incisional hernias
ter complete adhesiolysis of the whole abdominal
wall as described above, a 15×15-cm mesh was  Recurrences: 1/297 (0.3%)
 Trocar hernia: 1 (0.3%)
incised in a keyhole fashion and placed around the  Conversion: 1 (0.3%)
stoma. The mesh incision was closed by transfas-  Bladder laceration treated by Foley catheter: 1
cial sutures and tacks. A further mesh covering the  Relaparotomy due to bleeding: 1
midline incision and the stoma loop was also used.  Bowel fistula that healed after local revision and
vacuum-assisted closure therapy: 1
The stoma loop was finally placed between the two  Punctures due to seroma: 4, with 1 infection due to
meshes and lateralized for at least 5 cm. the puncture
A single dose of cefuroxime and metronidazole  Further revisions with resection of the hernia sac
was generally given prophylactically. because of persistent seroma or hematoma: 3, with
1 postoperative wound infection and 1 patient with
DynaMesh IPOM was used in all patients. intraoperative enterotomy leading to mesh explan-
It represents a real mesh structure that is warp- tation and recurrence
knitted from polyvinylidene fluoride. It contains  Delayed defecation: 5 patients
 Local revision of a stay suture: 1
a small amount of polypropylene on the parietal
 Strong pain and additional medical treatment over 3
side, providing good incorporation. months: 6 patients
 Patient deaths: 1 due to pulmonary embolism

Results

Incisional Hernia ⊡ Table 44.4. Clinical outcomes of laparoscopic repair


of parastomal hernias

⊡ Table 44.1 demonstrates the demographic data,  Recurrence: 1/47 (2%)


and ⊡ Table 44.3 summarizes the main surgical re-  Revisions because of stenosis of the stoma: 2, with a
consecutive wound infection in 1 patient
sults. Twenty-three percent (n=67) of our patients  Local revision because of abscess in the hernia sac
with an incisional hernia had undergone previous after puncture of a seroma: 1
repairs.  Conversion: 1 (2%)
Two patients developed a recurrence (0.6%).  Strong pain and delayed relief: 1 patient, but no
redo necessary because of pain
One recurrence occurred after explantation of the  No enterotomy
mesh. During surgical excision of the hernia sac,  No bleeding
because a persistent seroma caused pain, the mesh  No further delayed defecation
 No deaths
was incised and the small bowel opened. A formal
laparotomy was necessary to repair the bowel in-
jury, and the mesh was removed. Another patient
developed a hernia at the lower border of the with an unrecognized enterotomy had a complete
mesh, which was originally implanted because of recovery without persistent mesh infection.
a hernia after an upper midline incision. The new The only bladder injury healed after prolonged
defect was located in the midline between the um- transurethral drainage.
bilicus and the symphysis, despite a 5-cm overlap One patient died on the 7th postoperative day
of the lower end of the scar. because of pulmonary embolism.
A persistent seroma was observed in seven pa-
tients (2.1%) who had in common a small fascial
gap and a major hernia sac. Three of these seven pa- Parastomal Hernia
tients experienced major complications after punc-
ture or surgical removal of the sac: two infections Demographic data are given in ⊡ Table 44.2, and
and one mesh explantation. However, all patients the surgical results are shown in ⊡ Table 44.4. It
with a deep wound infection as well as the patient should be pointed out that 26% of the patients with
326 Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis

a parastomal hernia were primarily admitted with a The use of meshes made from polypropylene or
recurrent hernia. Only one patient (2%) developed polyester with an antiadhesive coverage represents
a recurrent hernia. One conversion was necessary a different approach. These meshes are effective
because no free abdominal cavity existed, and the in terms of incorporation and prevention of adhe-
pneumoperitoneum could not be established. sions. The shrinkage has been shown to amount to
The main problem, however, is the possibility about 20% [10, 13, 15]. No data exist concerning
of producing a stenosis of the stoma loop, which the incorporation behavior when two meshes are
occurred in two patients. In both cases, a preexist- used to overlap each other. Inert material that does
44 ing subcutaneous prolapse of the stoma loop was not adhere to visceral organs can be used as a real
associated with a sharp angulation at the fascial mesh structure, allowing an overlap of two or more
level, which was produced by the meshes. A lo- meshes. The meshes can be trimmed to the ideal
cal revision with shortening of the subcutaneous size, which is not possible when covered meshes
part of the stoma loop abolished the angulation are used.
and reestablished the passage. In one of these pa- PVDF is a very inert material that has long
tients, the intraabdominal part of the stoma loop been used as a suture material. Its long-term sta-
was perforated digitally. A formal laparotomy was bility is even better than that of polypropylene.
necessary for repair. The patient developed a deep The inflammation reaction on a cellular level is
wound infection around the stoma as well as in reduced, and the amount of fibrotic tissue is lower
the midline incision. With subsequent vacuum-as- compared with any other mesh material. The
sisted closure (VAC) therapy, the infected meshes shrinkage is comparable to that for covered poly-
could be preserved. propylene structures [9, 10, 16]. From an experi-
Another patient developed an abscess in the mental point of view, PVDF-based meshes may be
hernia sac after a persistent seroma was punctured. clinically useful.
Again, VAC therapy led to final preservation of the This prospective study demonstrating clinical
mesh and cure of the infection. results in 297 patients with incisional hernias re-
veals promising results. The recurrence rate was
very low compared with the literature. This may be
Discussion explained by the size of the meshes used through-
out, which was more than double that described by
The precondition for laparoscopic intraperitoneal other authors [6, 17].
onlay mesh (IPOM) repair of incisional and paras- One patient developed a recurrence after ex-
tomal hernias is the availability of meshes that plantation of the mesh. Another recurrence can
can be incorporated into the abdominal wall but only be explained by a suture-associated fascial
also prevent adhesions between the visceral organs defect, which has not been described in the litera-
and the mesh itself [12]. Up to now, most patients ture. The pathogenesis may be similar to the tack-
reported in the literature were treated with ePTFE- associated hernias described by LeBlanc [18].
derived meshes [6]. The visceral side, prevent- The laparoscopic repair of parastomal hernias
ing adhesions, is smooth, and the parietal side is also showed very good results. As we recently
rough or covered with polypropylene to provide demonstrated, the sandwich technique, which
strong incorporation into the abdominal wall. Ex- was used in the patients in the present study, is
perimental data, however, sometimes demonstrate superior compared with the original Sugarbaker
strong adhesions between bowel and mesh [10, technique [11]. Despite some promising results in
13]. Furthermore, mesh shrinkage is pronounced, the literature, our own series clearly showed that
leading to a 50% reduction of the original sur- the one-mesh technique according to Sugarbaker
face area [10, 14]. Also, an overlap of two ePTFE is sufficient only for medial defects of the fascia
meshes does not make any sense because the scar [19–21]. In cases of lateral or combined defects,
cannot grow through the meshes, which are in fact two meshes are needed to stabilize the abdominal
a real foil. wall. A precondition of the sandwich technique is
Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis
327 44
the availability of a mesh material that allows the needed to be punctured because of complaints.
meshes to overlap each other, with stable incorpo- Three patients underwent surgical excision of the
ration of both meshes; ePTFE-derived meshes are hernia sac because of a persistent seroma. These
foils that completely prevent any ingrowth of scar patients had a major hernia sac and a small fascial
tissue in both meshes. On the other hand, the key- defect less than 30 cm2. According to the literature,
hole technique seems to be an attractive and tech- seroma or hematoma often occurs, but only ultra-
nically easier alternative. In fact, there is one study sonography reveals the real rate of that complica-
with promising results [22], but the follow-up was tion [6, 17, 28].
only 6 weeks. These results, however, could not be Further complications are summarized in Ta-
confirmed in other studies [21, 23, 24]. ble 44.4 and proved to be rare. The low overall
Therefore, the sandwich technique seems to be complication rate supports the view that laparo-
the most effective approach for the repair of paras- scopic repair of incisional and parastomal hernias
tomal hernias. The only recurrence in our series with modern meshes such as DynaMesh IPOM is
was due to a surgical correction of a preexisting an effective and safe technique. The results seem to
subcutaneous prolapse of the stoma loop. Dur- be better than those obtained by open approaches
ing a local revision, the subcutaneous part of the [17]. At the least, the open repair of parastomal
stoma loop was shortened, and the intraabdominal hernias is much more effective compared with
part with adherent small bowel loops was pulled conventional techniques [29, 30].
between the two meshes. After that procedure, the In summary, DynaMesh IPOM was shown to
patient suffered from strong pain starting immedi- be a safe and effective mesh for the laparoscopic
ately after any oral intake. repair of incisional and parastomal hernias. The
Another major issue concerns the resistance of possibility of overlapping two or more meshes
meshes against infection. ePTFE-derived meshes provides an ideal overlap of the abdominal wall
must usually be removed if an infection occurs [25, in almost all situations and opens the way to the
26]. To our knowledge, nothing is known about sandwich technique for parastomal hernia repair,
the behavior of infected meshes covered with an which seems to be the best approach today. Infec-
antiadhesive barrier. Four patients in our series tious complications occurring in our study dem-
developed a deep wound and mesh infection after onstrated the resistance of PVDF against infec-
puncture or early surgical revision. In all cases, the tions. Experimental data exhibit excellent results
meshes were preserved. Recently we published a with regard to shrinkage and adhesion formation.
series of 25 patients prophylactically treated with Overall, the described technique for laparoscopic
a PVDF-derived three-dimensional mesh. One pa- incisional and parastomal hernia repair using Dy-
tient of this series underwent early relaparotomy naMesh IPOM provided satisfying results with no
because of an enterotomy leading to stercoral peri- mesh-related complications to date.
tonitis. After 5 days of daily revisions, the abdomi-
nal wall could be closed, and the intraperitoneal
mesh could also be preserved [27]. References
One patient developed a secondary bowel leak
due to unrecognized small bowel laceration with 1. Franz MG (2008) The biology of hernia formation. Surg
Clin North Am 88:1–15
a fistulization through the mesh, which healed
2. Millikan KW (2003) Incisional hernia repair. Surg Clin
uneventfully after VAC treatment. Enterotomies North Am 83:1223–1234
that had not been recognized during the primary 3. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC,
procedure occurred in about 2% of patients after Braaksma MM, IJzermans JN, Boelhouwer RU, de Vries BC,
laparoscopic incisional hernia repair. Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J (2000) A
comparison of suture repair with mesh repair for incisio-
Seroma or hematoma can be observed in al-
nal hernia. N Engl J Med 343:392–398
most 100% of our patients because we perform 4. Vrijland WW, Jeekel J (2003) Prosthetic mesh repair should
routine ultrasonography after 3–5 days. In a very be used for any defect in the abdominal wall. Curr Med
few patients (n=4) in this series, these seromas Res Opin 19:1–3
328 Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis

5. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk parastomal hernia repair using a nonslit mesh technique.
EG, Jeekel J (2004) Long-term follow-up of a randomized Surg Endosc 21:1487–1491
controlled trial of suture versus mesh repair of incisional 21. LeBlanc KA, Bellanger DE, Whitaker JM, Hausmann MG
hernia. Ann Surg 240:578–583 (2005) Laparoscopic parastomal hernia repair. Hernia
6. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE (2008) 9:140–144
Minimally invasive ventral herniorrhaphy: an analysis of 22. Hansson BM, de Hingh IH, Bleichrodt RP (2007) Lapa-
6,266 published cases. Hernia 12:9–22 roscopic parastomal hernia repair is feasible and safe:
7. Chelala E, Thoma M, Tatete B, Lemye AC, Dessily M, Alle early results of a prospective clinical study including 55
JL (2007) The suturing concept for laparoscopic mesh consecutive patients. Surg Endosc 21:989–993
fixation in ventral and incisional hernia repair: mid-term 23. Muysoms F (2007) Laparoscopic repair of parastomal her-
44 analysis of 400 cases. Surg Endosc 21:391–395 nias with a modified Sugarbaker technique. Acta Chir
8. Palanivelu C, Rangarajan M, Parthasarathi R, Madanku- Belg 107:476–480
mar MV, Senthilkumar K (2008) Laparoscopic repair of 24. Safadi B (2004) Laparoscopic repair of parastomal hernias:
suprapubic incisional hernias: suturing and intraperito- early results. Surg Endosc 18:676–680
neal composite mesh onlay. A retrospective study. Hernia 25. Heniford BT F, Park AF, Ramshaw BJ, Voeller G (2003) Lapa-
12:251–256 roscopic repair of ventral hernias: nine years’ experience
9. Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpe- with 850 consecutive hernias. Ann Surg 238:391–400
lick V (2002) PVDF as a new polymer for the construction 26. Berger D, Bientzle M, Muller A (2002) Postoperative com-
of surgical meshes. Biomaterials 23:3487–3493 plications after laparoscopic incisional hernia repair. Inci-
10. Junge K, Binnebosel M, Rosch R, Jansen M, Kammer D, dence and treatment. Surg Endosc 16:1720–1723
Otto J, Schumpelick V, Klinge U (2008) Adhesion forma- 27. Berger D (2008) Prevention of parastomal hernias by pro-
tion of a polyvinylidenfluoride/polypropylene mesh for phylactic use of a specially designed intraperitoneal onlay
intra-abdominal placement in a rodent animal model. mesh (Dynamesh IPST). Hernia 12:243–246
Surg Endosc 23:327–333 28. Susmalain S, Gewurtz G, Ezri T, Charuzi I (2001) Seroma
11. Berger D, Bientzle M (2007) Laparoscopic repair of pa- after laparoscopic repair of hernia with PTFE patch: is it
rastomal hernias: a single surgeon’s experience in 66 really a complication? Hernia 5:139–141
patients. Dis Colon Rectum 50:1668–1661 29. Carne PW, Robertson GM, Frizelle FA (2003) Parastomal
12. Berger D, Bientzle M (2006) Principles of laparoscopic hernia. Br J Surg 90:784–793
incisional hernia repair. Eur Surg 38:393–398 30. McLemore EC, Harold KL, Efron JE, Laxa BU, Young-Fadok
13. McGinty JJ, Hogle NJ, McCarthy H, Fowler DL (2005) A TM, Heppell JP (2007) Parastomal hernia: short-term out-
comparative study of adhesion formation and abdominal come after laparoscopic and conventional repairs. Surg
wall ingrowth after laparoscopic ventral hernia repair in a Innov 14:199–204
porcine model using multiple types of mesh. Surg Endosc
19:786–790
14. Johnson EK, Hoyt CH, Dinsmore RC (2004) Abdominal wall
Discussion
hernia repair: a long-term comparison of Sepramesh and
Dualmesh in a rabbit hernia model. Am Surg 70:657–661
15. Demir U, Mihmanli M, Coskun H, Dilege E, Kalyoncu A, Deysine: How did you prove the low adhesion
Altinli E, Gunduz B, Yilmaz B (2005) Comparison of pros- activity?
thetic materials in incisional hernia repair. Surg Today
Berger: These are only some experimental data.
35:223–227
16. Conze J, Junge K, Wei BC, Anurov M, Oettinger A, Klinge U,
And the PVDF is used for bacterial filtration. And
Schumpelick V (2008) New polymer for intra-abdominal you can only use bacterial filters with low adhe-
meshes–PVDF copolymer. J Biomed Mater Res B Appl sions of bacteria to the filter. If you do a sterile
Biomater 87:321–328 filtration, you can use PVDF as material for the
17. Pierce RA, Spitler JA, Frisella MM, Matthews BD, Brunt filter.
LM (2007) Pooled data analysis of laparoscopic vs. open
Kukleta: You saw less pain after the implantation.
ventral hernia repair: 14 years of patient data accrual. Surg
Endosc 21:378–386 Don’t you think it is the number of the fixation
18. LeBlanc KA (2003) Tack hernia: a new entity. JSLS 7:383– points that you use now? Do you use less than you
387 used before?
19. Sugarbaker PH (1985) Peritoneal approach to prosthetic Berger: In fact, I use the same number of sutures,
mesh repair of paraostomy hernias. Ann Surg 201:344–
but I do not use as many tacks as in previous
346
20. Mancini GJ, McClusky DA, Khaitan L, Goldenberg EA, times.
Heniford BT, Novitsky YW, Park AE, Kavic S, Le Blanc KA, Klinge: Some years ago we did experimental stud-
Elieson MJ, Voeller GR, Ramshaw BJ (2007) Laparoscopic ies with our microbiologists and looked at the
Chapter 44 · IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis
329 44
attachment of bacteria to different materials. We
quantified the amount of genetic material from the
bacteria of standard meshes that had been in con-
tact with various strains of bacteria. PVDF was not
free but belonged to materials where the amount of
genetic material was lowest.
Schumpelick: You used fewer tacks. Why?
Berger: The incorporation is better than with
ePTFE. At the beginning I was convinced that we
needed a permanent fixation. When I saw these
incredibly shrunken dual meshes of up to 75% and
all the tacks wandered with the mesh, I stopped
believing in any permanent fixation. I only want to
fix the mesh for a few days.
Schumpelick: How does it look after 2 years? Are
there long-term results available?
Berger: We have done some relaparoscopies and
relaparotomies and measured the mesh and found
shrinkage up to 10%—not more—and the mesh
was covered completely by a peritoneal layer.
Peiper: The material of the mesh is one thing. The
material of the fixation device is another thing.
Many adhesions occur not at the mesh area but
at the tacks. Do you have any experience with ab-
sorbable tacks?
Berger: I have started with absorbable tacks for
incisional hernia repair and always use absorbable
tacks for umbilical hernias. But the company sells
them for a very high price, and therefore I could
not decide to completely change to absorbable
tacks.
Kukleta: I was using Easy tacks for 3 years. If you
see adhesions, they are always at the tack, and the
adhesions will even pull out the tacks. So it is ex-
actly the same reaction that we have seen before.
I use the absorbable tacks now—maybe we can
afford a little more—but at the moment we do not
have any results, as they have been used only for 2
or 3 months.
45

Pooled Data Analysis of Laparoscopic


vs. Open Ventral Hernia Repair:
14 Years of Patient Data Accrual
B. D. Matthews, R. A. Pierce, M. M. Frisella, L. M. Brunt
332 Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual

Introduction tral hernia, incisional hernia, umbilical hernia, and


diastasis recti were identified and pooled. A similar
Incisional hernia is a common complication or con- search was also done on the broad-based keyword
sequence of abdominal surgery. In recent published laparoscopy. These two groups were combined to
series, the rate of incisional hernia after midline isolate those references common to both and were
laparotomy has been as high as 20% [23, 26, 29, 33]. further limited to studies conducted in humans
Due to recurrence rates as high as 30%, incisional and published in English. This final limitation pro-
hernias are not only associated with significant duced a total of 330 publications and their accom-
morbidity but may represent a significant financial panying abstracts. A manual review of the bibliog-
strain on the healthcare system [10, 11]. Over the raphies of several recent publications dealing with
last decade, mesh-based repair techniques have re- laparoscopic ventral hernia repair did not identify
45 placed primary suture repair for most incisional any additional citations within the defined time
hernia repairs because of an unacceptably high fail- frame that were missed. Studies were excluded
ure rate after primary repair [1, 6, 18, 19]. Neverthe- from consideration if they contained fewer than 20
less, open incisional hernia repair is often a major laparoscopic cases or if laparoscopic ventral hernia
operation, with the associated risks of wound- and repair was not the primary focus of the article. As a
mesh-related infections and hernia recurrence. As result, 78 published series that contained at least 20
an alternative approach, laparoscopic incisional her- subjects each and dealt primarily with laparoscopic
nia repair was developed and first reported in 1991 ventral hernia repair were further analyzed.
[16]. This technique is now increasingly used in the These 78 studies were separated into series that
management of patients with uncomplicated as well compared patients who had undergone laparoscopic
as more complex incisional hernias. or open ventral hernia repair within a given institu-
Thus far, nearly 100 studies have been published tion (»paired« studies) and series that described
on laparoscopic ventral hernia repair, although most only patients who had undergone laparoscopic ven-
represent small series of patients in uncontrolled tral hernia repair (»unpaired« studies). If a single
and nonrandomized trials from single institutions. group or institution had published multiple studies,
The aggregate data from these studies have not been then the largest series from the group was chosen
carefully analyzed on a large-scale basis, and only a for inclusion unless the studies involved distinct,
single meta-analysis involving a total of eight stud- nonoverlapping patient populations. If a group had
ies has been published [13]. Prospective random- published both a paired and an unpaired study, then
ized trials comparing laparoscopic and open ventral the paired study was chosen for analysis. Each of
hernia repair are ongoing in the United States and the 78 studies was then independently evaluated
Europe. To better understand the current status by two of three reviewers. Data extracted from
of laparoscopic ventral hernia repair and critically each selected report included patient demographics,
compare it with open techniques, we examined the hernia etiology characteristics, perioperative details,
published literature to evaluate studies reporting on postoperative complications, and hernia recurrence.
laparoscopic ventral hernia repair alone or in com- All studies that provided sufficient detail regarding
parison with open ventral hernia repair. complications and recurrences were included in the
analysis, even if some variables (e.g., mean hernia
size) were missing. Any discrepancies were resolved
Methods by consensus of all investigators after reviewing the
primary data again. This process led to the final
Study Selection selection of 45 total studies (14 paired, 31 unpaired),
which are listed in Appendices 45.1 and 45.2.
A Medline search was performed to identify all Intraoperative parameters that were evaluated
publications involving laparoscopic ventral her- included operating time, hernia and mesh sizes,
nia repair from January 1996 through January open hernia repair technique (mesh vs. primary
2006. Publications containing the keywords ven- suture), open conversion for laparoscopic cases, and
Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair
333 45
complications. Postoperative information on hos- laparoscopic or open ventral hernia repair in these
pital length of stay (LOS), complications, follow-up studies would have been selected from the same
duration, hernia recurrence, mortality, and cost of respective patient populations. In addition, com-
hospitalization were all recorded. Complications re- paring the results of the paired analysis to those
lated to the surgical procedure, including wound derived from the tenfold larger laparoscopic ven-
problems, mesh infection, trocar site hernia, seroma, tral hernia repair group used for the pooled analy-
and need for early reoperation, were evaluated. sis allows for external validation and extrapolation
Other postoperative complications were classified to a more global patient population.
into the following categories: cardiac, pulmonary, In several series, the patient populations were
gastrointestinal, genitourinary, thromboembolic, split into smaller subpopulations, and mean values
septic, neurologic/psychiatric, prolonged pain, and were given for these subgroups. In these instances,
miscellaneous. The perioperative mortality rate was a conglomerate weighted mean was calculated and
analyzed independently, but the principal cause of used in the final analysis. Likewise, many of the
death was also included as a complication. studies did not report standard deviations in their
statistical analyses, so weighted means were used to
perform the calculations. Accordingly, a two-tailed
Statistical Methods t-test was used to compare differences in these
weighted means, and any studies that had missing
Statistical analysis was performed by an indepen- data points were taken into account when per-
dent statistician. Two separate data sets were ana- forming the analysis. Because the raw numbers of
lyzed (paired studies comparing laparoscopic to complications, recurrences, and deaths were avail-
open ventral hernia repair and unpaired studies of able in all the studies that were evaluated, these pa-
laparoscopic ventral hernia repair only). Data from rameters were amenable to more thorough statisti-
the paired studies were analyzed as the primary cal analyses. Thus, totals for these data points were
evaluation and designated the »paired« analysis. calculated for both the laparoscopic and open ven-
Additionally, data from the unpaired laparoscopic tral hernia repair groups, and differences between
ventral hernia repair studies were combined with them were determined using chi-square analysis.
the laparoscopic ventral hernia repair data from the Alternatively, Fisher’s exact test was used in the
paired studies to create a pooled laparoscopic ven- event that the number of data points was too small
tral hernia repair group. These pooled laparoscopic to allow for use of a chi-square algorithm.
ventral hernia repair data were then compared
with the open ventral hernia repair data from the
paired studies and designated the »pooled« analy- Results
sis. In three instances, a given group had published
both a paired study as well as a more recent, larger A total of 45 reports met the inclusion criteria,
unpaired study that appeared to incorporate the including 14 paired and 31 unpaired studies. The
laparoscopic ventral hernia repair cases from the majority of these studies were retrospective (n=33;
smaller paired study. In these situations, the lap- 73%), whereas three of the paired and nine of the
aroscopic ventral hernia repair cases in the paired unpaired studies were done in a prospective fashion
study were included in the paired analysis, but they (12 total; 27%). These reports encompassed a total
were excluded from the combined analysis in lieu of 5,340 patients, including 4,582 (86%) who had
of the larger unpaired cohort. undergone laparoscopic ventral hernia repair and
The strategy behind this dual analysis (paired 758 (14%) who had open ventral hernia repair. Of
and pooled) was that the paired analysis should those 4,582 patients who underwent laparoscopic
have the greatest amount of internal validity, as the ventral hernia repair, 619 (14%) were reported in
same groups of surgeons were performing both the paired studies and 87% were from unpaired studies.
open and laparoscopic cases and so it was much Demographic data from the 45 studies are shown
more likely that the patients undergoing either in ⊡ Table 45.1. The mean patient age was 55.3 years
334 Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual

in the pooled laparoscopic group, 52.9 years in the paired studies and 28.5% of cases from the com-
paired laparoscopic group, and 56.1 years in those bined laparoscopic group. Two paired studies [12,
receiving open repairs (not significant). Only 19 34] that focused solely on umbilical hernias were in-
series reported the body mass index (BMI), five of cluded in the analysis. Both were paired studies, and
which were paired studies. In the five paired series, all of their open repairs were done using mesh. Con-
the weighted mean BMI was 30.5 for laparoscopic versely, two other paired studies [15, 28] reported
cases and 29.5 for the open cases (not significant). repairing some of their smaller ventral hernias using
In the pooled group, the laparoscopic repair patients a primary sutured technique. However, these 24
had a somewhat higher mean BMI of 32.6 compared cases of primary closure represented only 4.4% of
with the open repair patients (p=0.0026). the total number of open repairs. All laparoscopic
Each study was also examined for the num- repairs were done using intraperitoneal mesh.
45 bers of primary vs. incisional hernias and recurrent Operative data are shown in ⊡ Table 45.2. The
hernias. Few series included all three data points; mean operating time for the laparoscopic cases in
however, 12 of the 14 paired and 27 of the 31 un- the paired studies was 119.6 min, and 100.3 min
paired studies documented the number of recurrent when all the laparoscopic procedures are consid-
hernias that were operated. Among the open group, ered. The mean operating time for open repairs falls
25.2% of the hernias were recurrent, compared to between these two times at 104.5 min. The hernia
27.5% of those done laparoscopically in only the defect size (70.8 cm2) and the size of the mesh used

⊡ Table 45.1. Patient demographics

Open Paired p-valuea Pooled p-valueb


repairs laparoscopic cases laparoscopic cases
Patient number (n) 758 619 4,582
Percent male 49 49 44
Age (years) 56.1 52.9 0.13 55.3 0.49
Body mass index 29.5 30.5 0.57 32.6 0.003
Length of stay (days) 4.3 2.4 0.015 2.4 0.0004
Follow-up time (months) 20.2 16.9 0.47 25.5 0.16
aCompares open group to paired laparoscopic ventral hernia repair group
bCompares open group to pooled laparoscopic ventral hernia repair group

⊡ Table 45.2. Operative data

Open Paired p-valuea Pooled p-valueb


repairs laparoscopic cases laparoscopic cases
Operating time (min) 104.5 115.0 0.40 100.3 0.61
Recurrent hernias (%) 25.2 27.5 28.5
Hernia size (cm2) 70.8 87.9 0.40 103.4 0.025
Mesh size (cm2) 170.1 260.9 0.27 295.2 0.009
Enterotomy rate (%) 1.2 2.9 0.022 2.1 0.11
Conversion rate (%) 3.9 3.5
aCompares
open group with paired laparoscopic ventral hernia repair group
bCompares
open group with pooled laparoscopic ventral hernia repair group
Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair
335 45
for repair (175.5 cm2) were smallest in the patients nia repair (2.9% vs. 1.2%). Postoperative LOS was
undergoing open repair. The values are somewhat significantly shorter for the laparoscopic repairs, av-
larger (87.9 cm2 and 260.9 cm2) when compared di- eraging 2.4 days in both paired and pooled laparo-
rectly to the patients undergoing laparoscopic repair scopic ventral hernia repair groups compared with
in the same set of paired studies. However, the larger 4.3 days after open ventral hernia repair (p=0.015
hernia and mesh sizes become even more apparent and 0.0004, respectively).
when all the laparoscopic cases in the pooled group Total complication rates were significantly
are considered (103.4 cm2, p=0.025 and 295.2 cm2, higher with open ventral hernia (41.6%) compared
p=0.009, respectively). The enterotomy rate was to laparoscopic ventral hernia repair for both pooled
significantly higher in paired laparoscopic ventral (22.7%) and paired (25.5%) analyses (p<0.0001;
hernia repair cases compared to open ventral her- ⊡ Fig. 45.1). In the analysis of complications by or-

45
40
35 * p<0.0001
30
Incidence (%)

25 * *
20
15
10
5
0
OPEN PAIRED LAP POOLED LAP ⊡ Fig. 45.1. Total complications

⊡ Table 45.3. Organ system complications (NS not significant)

Open repairs (%) Paired p-valuea Pooled p-valueb


laparoscopic cases (%) laparoscopic cases (%)
Gastrointestinal 5.9 4.0 0.11 2.6 <0.0001
Cardiac 0.5 0 0.13 0.2 0.10
Pulmonary 1.7 0.8 0.14 0.6 0.0013
Septic 0 0 NS 0.02 1.0
Thromboembolic 0.3 0.2 1.0 0.1 0.20
Genitourinary 1.6 1.1 0.47 0.9 0.10
Neurological 0.1 0 1.0 0.02 0.26
Prolonged pain 0.9 1.0 0.93 2.0 0.047
Miscellaneous 1.9 1.0 0.18 0.7 0.0011
complicationsc
Mortality 0.3 0.3 1.0 0.1 0.32
aCompares
open group with paired laparoscopic ventral hernia repair group
bCompares
open group with pooled laparoscopic ventral hernia repair group
cIncludes fever, superficial thrombophlebitis, and psychiatric complications
336 Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual

gan system, the pooled laparoscopic ventral hernia pain rates were similar for the open and laparo-
repair studies reported significantly fewer wound, scopic ventral hernia repair paired series. Mortality
pulmonary, and gastrointestinal complications rates were also similar between groups. Wound
compared to the open ventral hernia repair series infection rates were 4.6–8-fold higher in the open
(⊡ Table 45.3). Only total and wound complication versus laparoscopic ventral hernia repair series for
rates were significantly different in the paired study both pooled and paired study comparisons and
comparison. No significant differences were noted accounted for most of the wound-related complica-
for rates of cardiac, thromboembolic, urologic, tions (⊡ Table 45.4). The number of mesh infections
or neurologic complications between any of the was also significantly higher with open ventral her-
study groups. In the pooled laparoscopic ventral nia repair for all comparisons. Interestingly, the
hernia repair group, prolonged postoperative pain incidence of postoperative seroma was similar for
45 was reported in a significantly greater percentage both open and laparoscopic series.
of patients (1.9%) compared to the open ventral The rate of hernia recurrence (⊡ Fig. 45.2) was
hernia repair group (0.92%); however, prolonged significantly lower with laparoscopic ventral her-

14

12

10
Incidence (%)

8 * p<0.0001
6

4 * *
2

0
⊡ Fig. 45.2. Hernia recurrence OPEN PAIRED LAP POOLED LAP

⊡ Table 45.4. Wound complications

Open repairs (%) Paired p-valuea Pooled p-valueb


laparoscopic cases (%) laparoscopic cases (%)

Wound infection 10.4 2.3 <0.0001 1.3 <0.0001

Total wound 16.8 5.3 <0.0001 3.8 <0.0001


complicationsc

Mesh infection 3.2 1.5 0.039 0.9 <0.0001

Seroma 12.0 12.1 0.95 11.5 0.66

Trocar hernia 0 0.4


aCompares
open group with paired laparoscopic ventral hernia repair group
b
Compares open group with pooled laparoscopic ventral hernia repair group
cIncludes wound hematoma/bleeding, cellulitis, dehiscence, and fat necrosis in addition to wound infection
Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair
337 45
nia repair for both the pooled (4.3%) and paired of internal consistency for comparison with open
(3.1%) study cohorts compared to the paired ventral hernia repair (the paired studies only), as
open ventral hernia repair series (12.1%, both well as a significantly larger group (the pooled
p<0.0001). Small variations existed in the length studies) that should give a broader view of the
of follow-up reported in the three groups of stud- field as a whole; this approach has proven useful
ies (25.5 months for pooled laparoscopic ventral in similar past analyses [33].
hernia repair, 16.9 months for paired laparoscopic In our analysis, we found the patient popula-
ventral hernia repair, 20.2 months for open ven- tions in both the pooled and paired laparoscopic
tral hernia repair), but these differences were not groups, as well as in the open surgery group, to be
significant. The reported incidence of trocar site demographically similar. All cohorts show a simi-
hernia in the laparoscopic series was only 0.35%. lar gender distribution, and the mean patient ages
across the groups of studies show little variation.
The vast majority of patients in the reported series
Discussion were clinically overweight or obese, not surprising
given that obesity is a strong predictive factor in
Large, single, and multi-institutional series have re- hernia formation and recurrence [24, 30, 31].
ported excellent results with few complications and The analysis of perioperative data showed that
recurrence rates of generally <10% after laparo- operative times were not significantly different for
scopic ventral hernia repair [3, 4, 8, 14, 17, 22, 27, open or laparoscopic approaches. However, there
32]. However, only one prospective, randomized, was considerable variation across studies in the
controlled trial comparing laparoscopic to open laparoscopic operative technique used, with some
incisional hernia repair [7] and one looking at lap- groups employing transfixion sutures routinely
aroscopic versus open repair of Spigelian hernias and others using them in a limited fashion or
have been reported [21]. Despite the growing body using only tacks. The variability in laparoscopic
of knowledge in the field of laparoscopic ventral technique and the fact that most series included
hernia repair, published overviews of the topic are cases that were part of the institution’s early experi-
largely review papers that have not pooled the data ence limit any definite conclusions about operative
and critically analyzed it as a whole [9]. A single time comparisons. The measured size of the hernia
meta-analysis evaluating eight studies and three defect and the size of mesh used, however, were
data sets (perioperative complications, operating greater in the laparoscopic reports than for the
time, and hospital LOS) has been published [13]. open patients, although these differences were sig-
The most stringent statistical method for ana- nificant for the pooled laparoscopic studies only.
lyzing any published data from multiple sources Possible explanations for these findings are that pa-
is a meta-analysis, requiring completeness and tients with larger defects are being selected for lap-
uniformity in the data reporting methods. Any aroscopic repair, the laparoscopic series are mea-
studies that lack a data point of interest, or that suring sizes of all the combined defects whereas
fail to report standard deviations along with their open reports describe the size of the largest defect
means, must be excluded from analysis. Such only, additional defects are being detected and re-
an approach in the area of ventral hernia repair paired with laparoscopic ventral hernia repair, or a
would exclude many potentially informative stud- combination of these variables. Similarly, it is not
ies because of the variable reporting methods used surprising that a larger mesh size was used with
in these reports. A pooled-data analysis of lap- laparoscopic ventral hernia repair because of the
aroscopic ventral hernia repair was performed in technique of covering all defects with a single piece
order to encompass a broad range of papers and of mesh without needing to dissect large tissue
achieve a more complete overview of the results flaps as with open ventral hernia repair.
and outcomes. Dividing the study population into Postoperative LOS for both the pooled and
»paired« and »pooled« groups allowed us to ex- paired laparoscopic groups averaged only 2.4 days
amine one cohort that should have a high degree compared to 4.3 days for the open group. The
338 Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual

reasons for shorter hospitalization with the laparo- hernia repair, during open ventral hernia repair
scopic approach are unclear but could be related the prosthetic mesh is more likely to contact the
to fewer complications, as discussed below, among patient’s skin, with the potential for seeding by
other variables. A shorter hospitalization could residual dermal flora.
also be a factor in the potential economic impact There was no difference in the rate of clinically
of laparoscopic ventral hernia repair, as recently significant seroma formation between the laparo-
addressed by Earle et al. [11]. scopic and open ventral hernia repair groups.
The primary outcome parameters were periop- One complication that occurred somewhat
erative complications and hernia recurrences. The more frequently in the laparoscopic group in the
analysis demonstrates that laparoscopic ventral paired analysis was enterotomy (2.9% laparoscopic
hernia repair was associated with a significantly vs. 1.2% open). Enterotomy during ventral hernia
45 lower overall complication rate compared to open repair is a major complication with potentially life-
ventral hernia repair in the paired analysis. This threatening consequences if unrecognized. The en-
difference was due primarily to more wound com- terotomies recorded in this analysis included both
plications in the open ventral hernia repair series. those that were recognized at the time of surgery
Some differences were also seen in other organ sys- as well as those discovered later due to a subse-
tem complications when the pooled laparoscopic quent complication. The occurrence of enterotomy
ventral hernia repair data were compared to open is probably related to multiple variables, including
ventral hernia repair for gastrointestinal, pulmo- surgeon experience, but most likely the primary
nary, and miscellaneous other complications such risk variable is the extent of intraabdominal adhe-
as fever and thrombophlebitis; however, these dif- sions. The presence of prior mesh hernia repair
ferences did not reach statistical significance in the may also be a factor in the risk for enterotomy dur-
paired comparison because of the smaller sample ing laparoscopic incisional hernia repair. In one
size. Another explanation for the differences in recent series, the incidence of enterotomy during
other organ system complications in the pooled laparoscopic ventral hernia repair in patients with
analysis is that groups reporting only on their lap- prior mesh placed was 11.4% compared with no
aroscopic experiences (i.e., studies included only in enterotomies in patients who had not had previous
the pooled analysis) may have accumulated more mesh repairs [25] .
extensive experience and achieved better outcomes Early postoperative pain was not evaluated in
with the laparoscopic procedure. this analysis, but prolonged pain was recorded in
One of the main potential advantages of lap- a somewhat higher percentage of patients in the
aroscopic incisional hernia repair is reduced pooled laparoscopic series compared to open, but
wound complications and mesh infections, and not in the paired analysis. These differences could
the results of our meta-analysis support this. The be accounted for in part by variable reporting
difference in wound complication rates between methods of prolonged pain as a »complication.«
laparoscopic versus open cases is largely a reflec- However, unlike most other laparoscopic proce-
tion of the decreased number of wound infections dures in which incisional pain is typically minimal,
seen in the laparoscopic group. Two major factors laparoscopic incisional hernia repair is associated
likely contribute to a reduced infection rate. First, with substantially more pain in the postoperative
open incisional hernia repair typically involves period because of the methods of mesh fixation.
extensive lateral dissection of tissue planes, with Specifically, the use of transfixion sutures for the
a large subcutaneous dead space and potentially mesh has been associated with increased pain after
altered blood flow. The mesh is often exposed to laparoscopic ventral hernia repair, but this issue
the subcutaneous space, with the potential for sub- was not addressed in our analysis.
sequent infection if a superficial wound infection The most important measure of an effective
occurs. With the laparoscopic approach, there is hernia operation is a low recurrence rate. In the
no flap dissection, and the mesh is placed intra- paired and pooled data sets, laparoscopic ventral
peritoneally. Second, unlike laparoscopic ventral hernia repair was associated with significantly
Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair
339 45
fewer hernia recurrences. These results do not than with open ventral hernia mesh repair. Hernia
appear to be explained on the basis of inadequate recurrence rates in short-term to medium-term
or short follow-up periods (mean 17–25 months), follow-up are acceptably low and are significantly
although longer-term studies with examination less than those reported in paired open ventral
at follow-up will ultimately be necessary to verify hernia cases. Studies with longer-term follow-up
these claims. Possible reasons for the lower recur- will be necessary to verify these results. Despite
rence rate with laparoscopic ventral hernia repair the limitations of this pooled-data analysis, it ap-
are that wide areas of tissue–prosthesis overlap pears that laparoscopic incisional hernia repair has
can be obtained. This broad interface should several distinct advantages over open approaches.
allow for better tissue–mesh integration and a Laparoscopic repair should be strongly considered
stronger repair with subsequent lower recurrence by surgeons with appropriate advanced laparo-
rates. A laparoscopic approach also provides a scopic expertise for patients with noncomplex in-
better opportunity to identify all hernia defects, cisional hernias.
some of which could be missed with an open ap-
proach.
It is important to consider some of the limita- Acknowledgments
tions of the data analysis. One potential shortcom-
ing of this study is the lack of complete statistical The authors wish to thank Dr. Yan-Yan in the
analysis of all data points studied. This, however, Department of Surgery and the Siteman Cancer
is largely due to inconsistent reporting of these Center, Washington University School of Medi-
data points across the studies evaluated. All the cine, Barnes-Jewish Hospital, St. Louis, Missouri,
examined series reported their total number of pa- for statistical support.
tients; greater than 95% reported mean patient age;
and approximately 85–90% gave information on
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2. Bageacu S, Blanc P, Breton C, Gonzales M, Porcheron J, Laparoscopic incisional and ventral hernioplasty: lessons
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342 Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual

20. Moreno-Egea DA, Martinez JA, Cuenca GM, Miquel JD, outcomes between open and laparoscopic [proce-
Lorenzo JG, Albasini JL, Jordana MC (2004) Mortality fol- dures], and you had to pull additional data without
lowing laparoscopic ventral hernia repair: lessons from
comparative analysis to make a strong point in
90 consecutive cases and bibliographical analysis. Hernia
8:208–212 favor of laparotomy.
21. Muysoms F, Daeter E, Vander MG, Claeys D (2004) Lap- Matthews: If you look at the pooled data, you
aroscopic intraperitoneal repair of incisional and ventral could say that is from laparoscopic experts, and is
hernias. Acta Chir Belg 104:705–708 that really applicable to the community surgeon
22. Parker HH, III, Nottingham JM, Bynoe RP, Yost MJ (2002)
who does everything? So you are right. If you look
Laparoscopic repair of large incisional hernias. Am Surg
68:530–533
at the paired analysis, everything looks very simi-
23. Perrone JM, Soper NJ, Eagon JC, Klingensmith ME, Aft lar in terms of those patient variables. Obviously,
RL, Frisella MM, Brunt LM (2005) Perioperative outcomes there were some differences with the complica-
45 and complications of laparoscopic ventral hernia repair. tions. You could argue that a laparoscopic ventral
Surgery 138:708–715 hernia repair should be done by an expert hernia
24. Reitter DR, Paulsen JK, Debord JR, Estes NC (2000) Five-
year experience with the »four-before« laparoscopic ven-
surgeon. In a meta-analysis, you can work the data
tral hernia repair. Am Surg 66:465–468 however you want it to come out.
25. Rosen M, Brody F, Ponsky J, Walsh RM, Rosenblatt S, Dup- Kukleta: Concerning the prolonged pain, in the
erier F, Fanning A, Siperstein A (2003) Recurrence after pooled group you found an increase on the lap-
laparoscopic ventral hernia repair. Surg Endosc 17:123– aroscopic side. Was there any possibility to take
128
a look at the technique of transfascial sutures and
26. Sanchez LJ, Bencini L, Moretti R (2004) Recurrences after
laparoscopic ventral hernia repair: results and critical re- the material used, because there are 25 U.S. papers
view. Hernia 8:138–143 where, in most, ePTFE was used. Here fixation
27. Szymanski J, Voitk A, Joffe J, Alvarez C, Rosenthal G (2000) must be stronger than everywhere else. Did you
Technique and early results of outpatient laparoscopic find any correlation?
mesh onlay repair of ventral hernias. Surg Endosc 14:582–
Matthews: You are absolutely right. Greater than
584
28. Toy FK, Bailey RW, Carey S, Chappuis CW, Gagner M, 90% of our pooled data used an ePTFE mesh. So
Josephs LG, Mangiante EC, Park AE, Pomp A, Smoot RT, there are some additional things that we can look
Jr., Uddo JF, Jr., Voeller GR (1998) Prospective, multicenter at.
study of laparoscopic ventral hernioplasty. Preliminary Schumpelick: Is it really justified to compare
results. Surg Endosc 12:955–959
laparoscopic versus an open approach without
29. Tsimoyiannis EC, Siakas P, Glantzounis G, Koulas S, Ma-
vridou P, Gossios KI (2001) Seroma in laparoscopic ven-
any functional results? After a laparoscopic ap-
tral hernioplasty. Surg Laparosc Endosc Percutan Tech proach, you have a defect of the muscles covered
11:317–321 by mesh. Sometimes there is a rectus diastasis in
30. Ujiki MB, Weinberger J, Varghese TK, Murayama KM, Joehl the midline, and in the open approach you close
RJ (2004) One hundred consecutive laparoscopic ventral
it. Therefore, we need a functional test of whether
hernia repairs. Am J Surg 188:593–597
31. Verbo A, Petito L, Pedretti G, Lurati M, D’Alba P, Coco C
there are differences or not. Have you seen such a
(2004) Use of a new type of PTFE mesh in laparoscopic test? The story of Reeves and Flament was to close
incisional hernia repair: the continuing evolution of tech- the hernia to increase the muscle stability of the
nique and surgical expertise. Int Surg 89:27–31 abdomen.
Matthews: More and more surgeons in the U.S.
do not use the laparoscopic approach on every pa-
Discussion tient—and in my practice as well—because, from a
functional standpoint, some patients benefit from
Deysine: If I were a reviewer of this paper, I would an abdominal reconfiguration or reconstruction.
address the need of a pooled data analysis. How- Flament: I was questioned about the selection of
ever, it is very difficult to compare unpaired data. patients. In Sevilla, Ramshaw said that hernias
So the valid comparison would be a data analysis with loss of domain are not suitable for laparo-
with paired groups. In the main table you pro- scopic treatment. Yesterday Predeep Chowbey said
duced, there was no major difference in several we have to select our patients, as laparoscopy is not
Chapter 45 · Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair
343 45
suitable for every patient. If so, the biggest hernias the large incisional hernias by the conventional
go to open surgery, and the smaller ones maybe go method, and when they come back with a recur-
to laparoscopic surgery. How can you introduce rence, which is usually a small hernia recurrence,
that in the analysis of the results? we handle it laparoscopically. That probably gives
Matthews: If you look at the results, the actual the best functional and anatomic results.
hernia size was much bigger in the laparoscopic
patients. So the selectivity, in terms of bigger ones
being done open and the smaller ones laparoscopi-
cally, did not really hold out in this analysis. I think
one of the things that actually really came out is
that, especially in the U.S., the average BMI of a
ventral hernia patient is morbidly obese—about
35—and so I have to consider that we are produc-
ing more morbidity and maybe increasing the
functional outcome, or is it a good trade-off? To
me, a lot of times that makes sense, and these are
the discussions I actually have with the patient.
We never discussed these things 5 or 6 years ago
with the patient. Selectivity has become more of
an issue.
Fitzgibbons: Actually, we are now usually recon-
structing the abdominal wall laparoscopically. I
routinely now close the defects. But to do that, of
course, you have to pick smaller hernias to some
extent. So we are individualizing. But you have
an enormous advantage of laparoscopy as you de-
crease the infection rate. In the right patient, it is
still a very good choice. And with regard to fixa-
tion with the tacks, my goal with the tacks is to seal
the polypropylene side of the prosthesis so that the
bowel cannot get in contact—not so much for the
fixation.
Deysine: You mentioned that patients were not
always operated by surgeons who were up to date
with the changes that have happened. You have
general surgeons doing this kind of operation,
sometimes with results that are not that great. The
essence of this conference should be spread to the
general surgical population until this becomes a
specialty.
Chowbey: As I mentioned yesterday, we have to
select the patients that we operate laparoscopically
or by conventional surgery with anatomical repair
reinforced by the mesh. And what we also empha-
size is that the recurrence after open surgery is
generally very small, and these small recurrences
can be very easily and comfortable managed lap-
aroscopically. That has been our policy. We treat
46

Tissue Ingrowth, Adhesion,


and Mesh Contraction
S. L. Bachman, A. Ramaswamy, B. J. Ramshaw
346 Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction

Introduction compared monofilament heavyweight polypropyl-


ene with lightweight multifilament polypropylene
As is the case with almost every medical interven- prosthetics. The heavyweight material had a more
tion, the use of surgical prosthetics for hernia repair intense inflammatory response with a correspond-
is a double-edged sword. While mesh has allowed for ing fibrosis. A dense plate of connective tissue com-
tension-free repairs and low recurrence rates, there pletely embedded the mesh. In comparison, the
has been a long learning curve regarding how to lightweight polypropylene material had a less pro-
appropriately fabricate and use these materials. The nounced inflammatory and fibrotic response, with
development of complications such as fistulas, pain, eventual formation of a thin scar framework and
mesh migration, and hernia recurrences are among fatty tissue interspersed within the mesh pores [2].
the complications our patients have suffered as mesh Mesh was laparoscopically inserted onto the
and placement techniques continue to evolve. abdominal wall in pigs and then examined at
It has become clear that mesh materials are 28 days by Jacob et al. [3]. They found that three-
46 not inert; they both stimulate a reaction in the dimensional (3D) polyester mesh took more force
organism and undergo changes over time while to be disrupted from the abdominal wall (4.15 N/
implanted [1]. This paper examines three interac- cm2) than oxidized regenerated cellulose-coated
tions between the body and mesh: tissue ingrowth lightweight polypropylene (3.11 N/cm2) or heavy-
into mesh and its effects, adhesions to mesh, and weight polypropylene (2.96 N/cm2). Histology was
mesh contraction in vivo. not quantified beyond demonstrating fibrous in-
growth between all mesh types [3].
A number of studies have looked at peel
Tissue Ingrowth strength as a proxy for integration. A comparison
in swine performed by McGinty et al. evaluated
»Ingrowth« of a mesh refers to the interdigitation heavyweight polypropylene, coated 3D polyester,
of the mesh with fibrous tissue. This was histori- and expanded polytetrafluoroethylene (ePTFE)
cally considered a positive property of a material, mesh. They found that the force of disruption was
as the ingrowth of collagen (scar) incorporates the 1.3 N/cm for ePTFE, 2.1 N/cm for heavyweight
mesh into the abdominal wall. However, it is also polypropylene, and 2.8 N/cm for polyester [4].
recognized that if ingrowth occurs on the visceral Additional histology demonstrated fibrous tissue
surface, such as on bowel or bladder, ingrowth is a between the pores of the polypropylene and poly-
negative effect that can lead to mesh contamina- ester weaves. There was fibrous tissue noted in the
tion and fistulas. micropores of the ePTFE surface, but there was no
Multiple studies have examined the ingrowth growth through the solid ePTFE [4].
of materials in animal models; the outcome mea- Gonzalez and Ramshaw reported on the histo-
sures of these studies are varied, including histo- logic differences between flat polyester, 3D polyester,
logic examinations of the tissue–mesh interface, and heavyweight polypropylene meshes 25 weeks
measurements of the force required to disrupt after implantation [5]. They found that fibrous en-
mesh from the abdominal wall, and sophisticated capsulation of the polypropylene was twice that
imaging models. of the polyester meshes, although polypropylene
Klinge et al. have demonstrated that mesh in- had less foreign body reaction than either polyester
corporation is the result of almost pure collagenous mesh. However, polypropylene had significantly less
tissue deposited around and between the mesh fi- connective tissue present than the polyesters did [5].
bers [2]. They demonstrated an acute inflammatory Histology demonstrated fibrous tissue within the
response after mesh insertion that peaked at 7–14 pores of the polypropylene and the polyester.
days, with concomitant fibroblast infiltration and The long-term ingrowth of mesh was studied by
a slow resolution of active cells in the wound bed Novitsky at al., who examined four types of mesh
until 90 days postoperative, when only a physiologic placed in an intraperitoneal location in rabbits [6].
cell turnover of <1% was noted [2]. This study Three barrier meshes–heavyweight polypropylene/
Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction
347 46
ePTFE composite, dual-sided ePTFE, and light- above, are a potential problem when the mesh is
weight polypropylene/oxidized regenerated cellu- exposed to the abdominal viscera. Polypropylene
lose (ORC) coating–were compared with macropo- and polyester have been used since the 1950s [9,
rous, uncoated, heavyweight polypropylene. The 10] and are two of the most frequently used types
strength of mesh incorporation into the abdominal of mesh in ventral hernia repair. They are struc-
wall was measured by three differentiated variable- turally macroporous and allow tissue, including
reluctance transducers. No significant difference chronic inflammatory tissue, to grow through the
was noted between the meshes in the force required pores. Macroporous meshes have been coated with
to disrupt the mesh from the tissue; however, the substances to place against the abdominal viscera
compliance of the surrounding tissue was signifi- to prevent ingrowth to bowel. However, when a
cantly higher in the lightweight polypropylene [6]. microporous (or solid) barrier is lacking between
Examination and measurement of the abdominal the viscera and the macroporous mesh, such as
wall after implantation of mesh in humans was per- when titanium is used as the coating substance,
formed by Welty et al. [7] using ultrasound and 3D there is potential for ingrowth of bowel.
stereography. Heavyweight monofilament polypro-
pylene mesh was compared to more elastic and low-
weight meshes. The patients with the heavyweight Human Studies
monofilament mesh had more complaints of par-
esthesias and abdominal discomfort, as well as more Evidence supports the contention that macropo-
recurrences (although not statistically significant). rous mesh should not be placed into the peritoneal
Three-dimensional stereography demonstrated in- cavity. Halm et al. [11] showed that reoperations
creased stiffness of all abdomens with mesh, but the following intraperitoneal polypropylene mesh
extent of the stiffness increased with mesh weight placement are much more difficult and dangerous
and decreased pore size [7]. These findings support than reoperations when mesh is placed outside the
the concept that a florid ingrowth around the mesh peritoneal cavity. There was a 76% complication
can be detrimental to a hernia repair. rate when operating on patients with mesh previ-
Thus, if the sequelae of fibrous reactions to mesh ously placed in the abdominal cavity, compared to
are considered more detrimental (extensive fibrosis, a 29% complication rate in patients who had mesh
loss of abdominal wall compliance, pain) than ben- placed outside the abdominal cavity. In this retro-
eficial, it would be helpful to understand which spective study of 66 patients, all eight bowel resec-
meshes will stimulate this reaction. An interesting tions and two enterocutaneous fistulas occurred in
study by Sanders et al. [8] took the concept beyond the group of patients who had mesh placed in the
pore size and investigated whether the size of mesh peritoneal cavity [11].
filaments affects the overall fibrotic ingrowth. Poly- A common mesh used for laparoscopic ventral
propylene fibers in four diameters ranging from hernia repair is ePTFE, which is designed for in-
2.0 μm to 27.0 μm were implanted in rat soft tissue traabdominal placement with a microporous side
for 5 weeks. After histology slides were obtained, the placed toward the abdominal cavity. A retrospective
thickness of the fibrous capsule surrounding each review reported the findings at reoperations in pa-
filament was calculated. Fibers that were smaller tients in whom ePTFE had been placed laparoscopi-
than 6.0 μm had no encapsulation in 87% of them, cally for ventral hernia repair [12]. The reoperations
and overall had significantly smaller capsules than in 65 patients showed that most patients (50/65) had
the fibers larger than 6.0 μm [8]. adhesions to the mesh; however, the adhesions were
mostly graded as easy to take down (44/50 were as-
signed a score of 1). It was also noted that no entero-
Mesh Adhesions tomies occurred during lysis of adhesions [12].
Another human study evaluated postoperative
The same factors that promote ingrowth of the adhesions using a dynamic ultrasound technique
muscular fascia of the abdominal wall, as described [13]. This study of 80 patients evaluated the inci-
348 Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction

dence of adhesion formation after open or laparo-


scopic ventral hernia repair using a polyester mesh
with an absorbable collagen coating designed for
intraperitoneal placement. Adhesions were present
at 1 year in 14% of patients by ultrasound exami-
nation [13].
The incidence of intestinal ingrowth when
using mesh coated with a solid microporous or
hydrogel-type barrier is unknown at this time.
Damage may occur during mesh manipulation or
fixation with tacks or sutures, which may strip off
the antiadhesive barrier and expose the macropo-
rous material to the abdominal viscera. ⊡ Fig. 46.1. Macroporous mesh being cut off the abdominal
46 wall but left on multiple loops of bowel due to ingrowth of
bowel into macroporous mesh
Animal Studies

There are numerous reports comparing mesh prod- operations mentioned earlier and can result in late
ucts placed in the abdominal cavity in animal ad- bowel obstructions and fistulas that can harm pa-
hesion models [4, 14–28]. Various animal models, tients (⊡ Fig. 46.2a, b). There are reports of fistulas
including rat, rabbit, and pig, have been studied to and bowel obstructions caused by intraperitoneal
look at mesh adhesions. In these animal models, placement of macroporous mesh up to 30 years
mesh is placed in the abdominal cavity and fixed to after implantation [28–32]. This evidence suggests
the peritoneal surface of the abdominal wall. The that even if macroporous mesh is no longer placed
peritoneum and/or abdominal contents, such as into the peritoneal cavity after today, we as surgeons
small bowel or cecum, are abraded to induce injury will continue to face difficult reoperations and will
that would simulate an abdominal wall hernia re- be managing enterocutaneous fistulas and bowel
pair in humans. By abrading the bowel, this injury obstructions due to macroporous mesh placed in
induces adhesion formation more reliably than if no the abdominal cavity for many more decades.
peritoneal damage were induced. Although slight
differences in the specific adhesion rates for each
type of mesh are observed when comparing these Mesh Contraction
studies, all of the studies show that the meshes de-
signed for intraabdominal placement (either with a Surgeons who have had the occasion to remove
solid microporous PTFE barrier or an absorbable mesh from patients will be familiar with the phe-
solid barrier) result in fewer adhesions compared nomenon of mesh contraction (⊡ Fig. 46.3a–c). The
with macroporous meshes, including lightweight acknowledgement of mesh contraction has led
macroporous meshes. to important changes in hernia repair technique.
An important concept when discussing adhe- An inadequate length of extension of mesh onto
sions to mesh is the fact that adherence alone is not healthy tissue may lead to recurrence if the mesh
a major problem for surgeons who must reoper- retracts away from the hernia.
ate on a patient with a previous mesh placement. The phenomenon of mesh contraction has been
An adhesion to mesh may rarely cause pain or documented in experimental models, such as that by
bowel obstruction for the patient, but long-term Klinge et al. [33]. This canine study established that
complications and difficult reoperations occur if mesh contraction occurs as early as within 4 weeks
there is ingrowth of the abdominal viscera into and after implantation. They noted that heavyweight
through the mesh (⊡ Fig. 46.1). This ingrowth of polypropylene was reduced to 54% of its original
viscera can lead to the difficult and dangerous re- size, and a reduced-weight polypropylene mesh was
Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction
349 46

⊡ Fig. 46.2. a A mesh designed for intraabdominal placement b


[heavyweight polypropylene/polytetrafluoroethylene (PTFE)
composite] was used in a laparoscopic ventral hernia repair.
b A stitch was placed in the center of the mesh to help posi-
tion the mesh laparoscopically. The stitch apparently caused a
defect in the expanded PTFE, and an enterocutaneous fistula
developed a year after the operation

66% of its implantation size [33]. Many other inves-


tigators have also documented shrinkage of pros-
thetics in vivo. Coda et al. found that prosthetics
would shrink or even expand in response to being
bathed in different types of fluids [34]. Gonzalez
et al. explanted mesh from swine abdominal walls c
3 months postoperatively and found that the mean
size of heavyweight polypropylene squares was 67% ⊡ Fig. 46.3. a A composite heavyweight/expanded polytetraflu-
of their original size, and flat polyester mesh was oroethylene (ePTFE) mesh immediately after being excised from
87% of its original size [35]. They also studied tissue the anterior abdominal wall. Note the scalloped edges that have
exposed the heavyweight component to the viscera. b An ePTFE
integration and found that a higher force was neces- explant after tissue has been removed. The mesh is stiff and
sary to distract the polyester mesh (mean 194 N) contracted into this twisted shape. c A composite heavyweight
versus the polypropylene (159 N) [35]. polypropylene/ePTFE mesh after explantation and cleaning
350 Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction

In another swine study, early explanation at the sequelae of scar plate formation around the
28 days demonstrated that 3D polyester mesh was mesh while still obtaining the ingrowth that helps
70.5% of its original size, heavyweight polypropyl- secure the mesh’s position, diminish contraction,
ene was 74.7%, and lightweight polypropylene with and prevent adhesions to the visceral surface of the
ORC was 66.4% of the initial size [3]. A study with mesh. We can expect to see more refinements of
4-week explants found that heavyweight polypro- the materials used in hernia repair in the future.
pylene was 94% of its original size, 3D polyester was
79%, and ePTFE was 63% of the original size [4].
At 1 year postoperative, Novitsky et al. found that References
ePTFE had contracted by a mean of 32.1%, ePTFE/
heavyweight polypropylene composite by 8.9%, 1. Costello CR, Bachman SL, Ramshaw BJ, Grant SA (2007)
heavyweight polypropylene by 4.6%, and lightweight Materials characterization of explanted polypropylene
polypropylene coated with ORC by 8.7% [6]. hernia meshes. J Biomed Mater Res B Appl Biomater
46 The early timeline of contraction implicates the
83B:44–49
2. Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze
immediate wound-healing inflammatory response J, Schumpelick V (2002) Impact of polymer pore size on
as the mechanism. The initial deposition of collagen the interface scar formation in a rat model. J Surg Res
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sue ingrowth and bowel adhesion formation in an animal
ing a daily low dose of steroid to swine with three
comparative study: polypropylene versus Proceed versus
types of mesh implanted on the anterior abdominal Parietex Composite. Surg Endosc 21:629–33
wall. A second group of animals did not receive the 4. McGinty JJ, Hogle NJ, McCarthy H, Fowler DL (2005) A
injection. Mesh was explanted at 3 months. There comparative study of adhesion formation and abdominal
was variable contraction between the groups, but all wall ingrowth after laparoscopic ventral hernia repair in a
porcine model using multiple types of mesh. Surg Endosc
three types of mesh in the steroid-treated animals
19:786–90
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untreated mesh (manuscript in preparation). integration between polyester and polypropylene pros-
Surveying the literature on mesh contraction theses in the preperitoneal space. Am Surg 69:471–6;
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6. Novitsky YW, Harrell AG, Cristiano JA, Paton BL, Norton
heavyweight polypropylene contracts more, some-
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Some researchers have hypothesized that the loca- growth, and textile properties of prosthetic meshes after
tion of the mesh in the abdominal wall will influ- long-term intra-abdominal implantation in a rabbit. J
ence contraction [36]. However, there does seem Surg Res 140:6–11
to be a trend that an increased load of foreign 7. Welty G, Klinge U, Klosterhalfen B, Kasperk R, Schumpelick
V (2001) Functional impairment and complaints follow-
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Mater Res 52:231–7
9. Usher FC, Ochsner J, Tuttle LL, Jr. (1958) Use of mar-
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10. Usher FC, Wallace SA (1958) Tissue reaction to plastics; a
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351 46
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352 Chapter 46 · Tissue Ingrowth, Adhesion, and Mesh Contraction

Discussion that there is some difference, but we do not know


what happens.
Deysine: The degradation is usually secondary to Ramshaw: I completely agree. Polypropylenes are
white cell proximity. I was wondering whether, in not the same; there are a lot of differences in the
some of the specimens that you removed, you tried way they are constructed; there is a high variability
to analyze the contained bacteria as the orthope- in the degree of degradation. Potential variables
dists do with their prostheses. They could not find are the length of time implanted, the bacterial mi-
the bacteria by normal ways. lieu, more degradation with infection, the different
Ramshaw: That is an excellent point. There will be types of fibers themselves. We are going to try to
an accelerated amount of oxidation in infection. In look at it as we start to correlate all of the variables
the infected meshes, we have not done any evalu- together in this large database.
ation of the bacteria. This is one of the things we
want to look at. We also want to look at the clinical
46 correlations from infection, chronic pain, recur-
rence, etc., and the patient characteristics such as
smoking, diabetes, and age. All we have done is
assess clinical signs of infection.
Franz: I particularly liked the distinction between
surface adhesion and ingrowth. With regard to bi-
ologics, if patients have a contaminated abdomen
or after failed synthetics, they are not interested in
another synthetic. Technique aside, do you think
cross-linking is good or bad?
Ramshaw: I could certainly give you the market-
ing point of view on it: If it’s a company without
cross-linking, cross-linking is bad because you
want regeneration, and the cross-linking will pre-
vent some of that cellular ingrowth or differentia-
tion. Companies that have cross-linking say that
non-cross-linking is bad because it is a risk for
early degradation. I think the answer is that we
have a lot of first-generation biologics, and we
really have not solved the real issue of getting
those cells to come in and differentiate into the
right types of material in the right patient. And
that is what I think the next generation of biolog-
ics may actually be better designed to do for our
patients.
Klinge: You described the degradation of polypro-
pylene. Usually, pure polypropylene is not suitable
to make filaments, and there are a lot of additives
and other substances which are mixed to the poly-
propylene. Unfortunately, we do not know what
these additives are. Did you see any differences in
the degradation process between the various poly-
propylenes? Some years ago, we saw in histological
analysis that some of the propylene heavyweight
meshes behaved better than expected. I believe
47

Effect of Different Mesh Materials


on Adhesion Formation
S. Morales-Conde, J. Martín-Cartes, M. Socas
354 Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

Introduction Factors Related to Adhesion Formation


with Prosthetic Materials
Because of the necessity of placing prosthetic
materials to reduce the high rate of recurrence The formation of adhesions is an extremely complex
associated with conventional hernia repair with- process that has not yet been completely explored.
out mesh, aggressive dissection of tissues occurs As a result, many of the studies on this phenom-
during conventional open repair. Laparoscopic enon are still empirical, but the results published so
surgery has introduced a new technique for re- far are promising. It is possible that we will be able
pairing defects of the anterior abdominal wall to control this process in the near future, whether
in order to avoid this large dissection, which is stimulating or inhibiting it, depending on the cir-
associated with discomfort, the use of drains, cumstances. The consequence of this could be the
the possibility of contamination and infection of possibility of applying these prosthetic materials for
the meshes used, and a long hospital stay for the intraabdominal use in laparoscopic surgery of the
patient. These effects have led surgeons to accept abdominal wall with no risk of creating adhesions
the laparoscopic approach as a valid option for and their subsequent consequences, such as fistulas
47 our patients [1]. and bowel occlusion.
Laparoscopic surgery and its application in In the meantime, while we try to determine
the treatment of ventral hernia have produced a the different factors involved in adhesion forma-
change in surgeon mentality. Before the advent of tion, the ideal materials and substances to prevent
this technique, surgeons always avoided placing adhesions are still far from being found. Different
foreign materials in contact with intraabdominal studies performed so far have proved that it is pos-
viscera in order to avoid adhesions. sible to reduce the quantity and the quality of these
Laparoscopic repair of ventral hernias is as- adhesions but not to prevent them completely. Full
sociated with the use of intraabdominal pros- tissue integration without adhesion formation is
theses. This has improved the evolution of these still a challenge in the use of intraabdominal mesh
materials toward better ingrowth to the anterior materials.
abdominal wall, but at the same time it has re- Different factors have been associated with the
duced the possibility of creating adhesions and process of adhesion formation, but the need of the
their potential complications, such as fistulas and bowel and intraperitoneal organs to isolate foreign
bowel occlusion [2]. agents (prosthetic materials, sutures, bacteria, etc.)
The ideal mesh for intraperitoneal placement seems to play an important role. However, during
has yet to be found. It should follow the principles laparoscopic repair of ventral hernia, the presence
for any prosthetic material, such as being steril- of intraperitoneal adhesions is a result not just
izable, noncarcinogenic, chemically inactive, and of the material itself; experimental studies have
resistant to physical manipulation, and it should related adhesions to the surgical technique used.
cause no inflammation, change in mesh character- Spiral tacks, improper placement and fixing of the
istics, altered tissue contact, or allergic or hyper- mesh, and exposure of the sides of these materials
sensitivity reaction. Moreover, the optimal mesh to the intraabdominal viscera could be related to
should have certain characteristics when placed adhesion formation [3].
intraabdominally: minimal pain and adhesion for- We also lack information about the healing
mation, excellent tissue ingrowth with minimal process involved in adhesion formation. It would
shrinkage, no formation of fistula or infection, and be interesting in the future to determine the criti-
minimal seroma formation. It is also important cal moment when adhesions to prosthetic mate-
that the prosthetic material cause no change in ab- rials are formed. For that reason, some authors
dominal compliance while at the same time being have designed different studies using sequential
easy to manipulate. laparoscopy to monitor the real-time adhesion for-
mation process and the critical period when most
adhesions form [4, 5].
Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation
355 47
If we analyze the factors involved in adhesion [20] has demonstrated the influence of the
formation when a mesh in placed intraperitone- surgical technique of mesh placement during
ally, we can determine the following: laparoscopic ventral hernia repair (LVHR). In
▬ Material: Different studies [6–12] have shown this study, most of the adhesions to the ePTFE
that the porosity of the material is one of the meshes were observed at the edges, compared
most important factors related to adhesion with the central part of this prosthetic mate-
formation and ingrowth. Large porosity has rial. The potential reasons for these adhesions
been related to an increased number of ad- were analyzed, and it could be seen how ad-
hesions. Polypropylene mesh (PPM) is con- hesions formed to the undesired exposition of
sidered a high-porosity prosthetic material the parietal face of the prosthesis or to tacks
that creates an important scar tissue involved improperly introduced into the mesh. These
in adhesion formation. On the other hand, a issues demonstrate the need for a meticulous
low-porosity material, such as expanded po- technique to avoid complications related to
lytetrafluoroethylene (ePTFE) [6–9, 13, 14], adhesions, such as bowel occlusion and perfo-
produces a tissue capsule that covers the mesh ration. The mesh must be properly extended
with a low rate of adhesions. Therefore, we so that the parietal face is not exposed to the
can conclude that the pore size of the mesh is bowel, and tacks should be introduced all the
critical in the development and maintenance way into the mesh to avoid their hanging from
of abdominal adhesions and tissue ingrowth. the anterior abdominal wall.
It has been demonstrated, however, that re- ▬ Fixation: As stated previously, adhesions to
ducing the amount of material and increasing spiral tacks may occur, and we have observed
the pore size result in better mesh biocompa- these in experimental studies. Recent clinical
tibility, with a potential reduction of adhesion papers have even reported cases of obstruction
formations [15, 16], as some have tried to and/or perforation of the small bowel resulting
demonstrate with the new lower-weight PPM. from a band adhesion caused by a displaced
These large-pore PPMs in the intraabdominal spiral tack [21, 22].
position have shown a reduced inflammatory ▬ Surgical trauma: Surgical trauma to the bowel
tissue reaction, so they could be considered an or to the peritoneal surface of the anterior ab-
alternative for the development of intraperi- dominal wall during the process of adhesioly-
toneal onlay meshes [17]. In fact, new studies sis has some influence in adhesion formation,
with reduced-weight PPM have demonstrated even if the ideal intraabdominal mesh is used.
less change in the adjacent tissue’s pliability/ Adhesions result from the normal peritoneal
compliance and less adhesion than conventio- wound-healing response and develop during
nal PPM [18]. the first 5–7 days after injury. Adhesion forma-
In the future, these factors should also be ana- tion and adhesion-free reepithelialization are
lyzed with regard to the pore size of other alternative pathways. These both begin with
materials, such as PTFE. The larger-pore, thin- coagulation, which initiates a cascade of events
ner meshes such as condensed PTFE (cPTFE) resulting in the buildup of a fibrin gel matrix.
have led to better tissue integration compared If not removed, the fibrin gel matrix serves as
with the other PTFE-based meshes or PPM. the progenitor to adhesions by forming a band
Through hydrophobic chemistry, a low pro- or bridge when two peritoneal surfaces coated
file, and increased pore size, cPTFE balances with it are opposed [23]. The band or bridge
the rapid resolution of the inflammatory and becomes the basis for the organization of an
wound-healing response to resist adhesion for- adhesion, especially if a foreign body reaction
mation, with efficient integration within the is added to the process when a mesh is placed
surrounding abdominal tissue [19]. intraabdominally, becoming of great impor-
▬ Surgical technique for placing the mesh: An tance to the surgical trauma on the bowel sur-
experimental study conducted by our group face [24].
356 Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

Analysis of the Influence of sion formation. This study clearly points to very
Different Prosthetic Materials few mesh-related complications after a proper
on Adhesion Formation mesh is placed intraperitoneally and shows that
experimental studies and theoretical consider-
Many prosthetic materials to be placed intraab- ations may argue for using a covered mesh (a
dominally during LVHR are available on the mar- composite mesh or ePTFE) for LVHR in humans,
ket, and new meshes are introduced regularly. although it is stressed that no human data at the
However, experimental and clinical documenta- moment support this. The only clinical informa-
tion on safety, including information on adhe- tion available in the literature based on reopera-
sions, fistulas, bowel occlusion, infection, and ef- tive findings concerning adhesions to prosthetic
ficacy, are often not available to the clinician. materials placed intraabdominally was published
The choice of mesh may therefore be difficult in by Koehler et al. in 2003 [26]. They reported on
clinical practice. a multi-institutional study of adhesions to im-
Regarding adhesion formation, different planted ePTFE mesh at reoperation in patients
experimental studies on animals show differ- who had previously undergone laparoscopic in-
47 ent results (⊡ Table 47.1), and a mesh superior cisional hernia repair done with the same mesh
to another in terms of adhesion formation in implantation technique. In this large series of
one study may be inferior to the same mesh in reoperations after LVHR, no or minimal adhe-
another study. If we analyze the different stud- sion to implanted ePTFE mesh was observed in
ies, the problem might be related to the fact that 91% of cases, and no severe cohesive adhesions
they involved different implantation techniques were found.
and were carried out in different animal mod- Regarding the two types of prosthetic materials
els. In addition, the different factors analyzed accepted for intraabdominal placement, it is im-
previously–such as manipulation of the abdomi- portant to consider the following factors:
nal viscera, fixation technique, size of the mesh, ▬ ePTFE: Traditionally, ePTFE is one of the
size of the visceral face of the mesh in relation to most widely used prosthetic materials for
the parietal face (overlap), and management of repairing abdominal wall defects, but it has
the abdominal wall area where the mesh is to be been suggested that its behavior with respect
placed–may influence the results of the various to the reparative process may depend on its
studies, but in most cases, these factors are not structure and that this factor should be con-
even described in the text. sidered to determine the capability to form
A current review of the literature has been adhesions.
published regarding safety measures such as ad- ▬ Composite materials: Composite biomate-
hesions, fistulas, and infections after LVHR [25]. rials designed for repairing abdominal wall
The only real concern based on this analysis defects are usually composed of a reticular
is about using pure PPM in the intraperitoneal component and a second component, or
position. The use of intraperitoneal PPM to re- barrier, which is laminar (absorbable or
pair incisional hernias has been demonstrated in nonabsorbable) and placed in contact with
clinical and experimental studies to carry the risk the visceral peritoneum. Results on the
of adhesion and damage to the intraabdominal effectiveness of these membranes cover-
viscera. Polypropylene is a material widely used ing PPM or polyester mesh are related to
in surgery, but because of its association with the the membranes’ composition, but they are
formation of enterocutaneous fistulae and adhe- contradictory: Studies with PPM covered
sions, direct contact between mesh and intestine with materials such as polyglactin 910 mesh
is avoided. But, as has been analyzed previously, (PGM), with the aim of avoiding contact
the use of PPM may be reevaluated based on the between the PPM and the intraabdominal
new studies of lightweight macropore meshes viscera, demonstrated that the interposition
to determine whether it could influence adhe- of PGM did not alter adhesion formation
Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation
357 47
[27]. On the other hand, other studies de- to prevent or reduce adhesions have largely been
signed to evaluate how the composition of unsuccessful, hindered by the empirical basis,
this second component affects the biological the biochemical complexities of adhesiogenesis,
behavior of the biomaterial and the forma- and the lack of good predictive animal models.
tion of adhesions have shown that physical The two major strategies for adhesion preven-
barriers seem to induce similar adhesions, tion or reduction consist of adjusting surgical
while adhesions formed to prostheses with technique, as already proposed, and applying
chemical barriers can vary considerably, adjuvants.
possibly depending on the chemical compo- Different studies have been published that
sition of the barrier [28]. Finally, the same used a variety of substances to prevent adhesion
amount of adhesion despite the presence of formation to the prosthetic materials, with vary-
different protective barriers has been de- ing results. Hyaluronic acid/carboxymethylcellu-
monstrated with other polypropylene-based lose (HA/CMC) membranes have been used as
meshes [29]. an effective measure to prevent PPM-induced
adhesions; taurolidine 2% solution has been pro-
In conclusion, it is difficult to make a final state- posed as a cost-effective alternative to HA/CMC
ment because the results of different studies are so membranes when a PPM is placed in direct con-
contradictory. Whereas some studies have demon- tact with the abdominal viscera [36]; hyaluronate
strated the superiority of some composite meshes sodium in the form of a bioresorbant membrane
over ePTFE [30–33], others showed ePTFE to be has been demonstrated to significantly reduce
related to less adhesion formation [18, 29, 34], and the development of intraabdominal adhesions
there are even studies in which the two types of found after implantation of a PPM in the con-
mesh are similar [35]. The literature cannot give text of surgical hernia repair [37]; and a colla-
general recommendations for the choice of mesh gen foil has also been used to reduce adhesion
based on randomized controlled trials. The final formation [38].
choice of mesh for LVHR will therefore typically Looking for a cost-effective alternative to re-
be based on cost and the surgeon’s preference duce adhesion formation to mesh placed intraab-
while we await further data from randomized con- dominally during LVHR, we have conducted stud-
trolled clinical trials. ies with two substances that can guarantee good
coverage of the complete surface of the mesh, even
if a large prosthetic material is used [39, 40]. These
Reducing Adhesion to Prosthetic two substances are fibrin glue (Tissucol; Baxter
Materials Biosurgery, Vienna, Austria) and hyaluronidase
cream.
As already mentioned, meticulous technique is Both substances were able to decrease, in
one of the most important factors involved in an animal model, the number and quantity of
reducing adhesion formation: Avoid unnecessary adhesions with PPM and ePTFE meshes. The
surgical trauma on the surface of the peritoneum adhesion reduction with hyaluronidase cream is
and the serosa of the bowel; avoid exposing the a consequence of an acceleration in the normal
parietal face of the mesh to the abdominal cav- healing process needed to create adhesions. This
ity; and avoid letting spiral tacks hang from the factor may also influence the reduction of adhe-
mesh because of improper introduction through sions with fibrin glue, but it may be related to
the prosthetic material. other factors, such as the mechanical barrier that
But because these circumstances are not usu- the fibrin glue produces 3–5 min after its applica-
ally present, due to the process of adhesiolysis or tion and the capsule of new tissue created by the
to a defect location that makes placement of the fibrin glue through a healing process different
mesh or tacks difficult, alternative methods to from the inflammatory process necessary to cre-
avoid adhesion are under investigation. Efforts ate an adhesion.
47
358

⊡ Table 47.1. Experimental studies comparing adhesion formation of different prosthetic materials (lap laparoscopic; PP polypropylene mesh; ePTFE expanded polytetrafluoro-
ethylene; PHD glycerol-preserved human dura mater; PGA polyglycolic acid; PVDF polyvinylidene fluoride)

Year Author Animal N Meshes Open / lap Fewer adhesions More adhesions Time

1983 Jenkins et al. [41] Rats 196 PP (Marlex) Open Vicryl PP (Marlex ) 1, 2, 4, and 8 weeks
Vicryl PP (Marlex) + Gelfilm
ePTFE (STP)
Silastic
PHD
PP (Marlex) + Gelfilm

1993 Naim et al. [42] Rats PP + ePTFE (STP), Open PP + Interceed –


PP + Interceed
PP + Poloxamer

1996 Bellón et al. [43] Rabbits 24 PP (Marlex) Open ePTFE (Mycromesh) PP (Marlex) 14, 30, 60, and 90 days
ePTFE (MycroMesh)

1997 Baykal et al. [44] Mice 72 PGA Open PGA PP 5 and 14 days
PP

1998 Dasika and Widmann Rats 47 PP Open Vicryl PP 1, 2, and 3 months


[45] Vicryl PP +Vicryl
PP +Vicryl

1999 Bellón et al. Rabbits 48 ePTFE (STP) Open ePTFE (STP) – 14, 30, 60, and 90 days
[46] PP (Marlex) Lyodura
Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

PP (Prolene)
Lyodura

2000 Vrijland et al. Rats 44 PP Open PP + Fluorosoft PP + Vicryl 60 days


[47] PP + Vicryl
PP + Fluorosoft

2000 Bellón et al. [48] Rabbits 8 ePTFE (MycroMesh) Open PP (Marlex) 3 and 7 days
ePTFE (DualMesh)
ePTFE (STP)
PP (Marlex)

2002 Bellón et al. [49] Rabbits 14 ePTFE (DualMesh) Open ePTFE (DualMesh) ePTFE (CV-4) 14 days
ePTFE (CV-4)

2002 Zieren et al. [50] Rats 40 ePTFE (DualMesh) Open No differences No differences 14 and 90 days
▼ PolyesterComposite
2003 Van ’t Riet et al. [51] Rats 91 PP Open Sepramesh PP 7 and 30 days
PP + Icodextrine Parietex PP + Icodextrine
Sepramesh
Parietex

2003 Matthews et al. [14] Rabbits 30 ePTFE (DualMesh) Open ePTFE (DualMesh) PP (Marlex) 1, 3, 9, and 16 weeks
PP (Marlex)

2004 Borrazzo et al. [52] Pigs 21 PP Lap Sepramesh 28 days


ePTFE (DualMesh)
Sepramesh

2004 González et al. [53] Rats 80 PP (Parietene) Open Parietex Composite PP (Parietene) 21 days
Parietex Composite Parietene Composite Sepramesh
Parietene Composite Composix E/X
Composix E/X ePTFE (DualMesh)
Sepramesh
ePTFE (DualMesh)

2004 Butler and Prieto [54] Guinea 19 PP (Prolene) Open PP (Prolene) + AlloDerm 4 weeks
pigs PP (Prolene) + AlloDerm

2005 Kayaoglu et al. [35] Rats 60 PP (Surgipro) Open Sepramesh 4 weeks


Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

ePTFE (DualMesh) ePTFE (DualMesh)


Sepramesh
Vypro II
Parietex Composite

2005 Matthews et al. [29] Rabbits 30 ePTFE (DualMesh) Open ePTFE (DualMesh) 1, 3, 9, and 16 weeks
Composix E/X
Sepramesh

2005 Demir et al. [55] Rats 30 PP (Bard Mesh) Open PP (Bard Mesh) + 14 days
Composix E/X Interceed
PP (Bard Mesh) + Inter-
ceed
359

2005 McGinty et al. [30] Pigs 8 PP (Prolene) Lap Parietex Composite 28 days
ePTFE (DualMesh)
Parietex Composite

2005 Konstantinovic Rats 48 PP (Marlex) Open PP (Marlex) (30 days) 30 and 90 days
▼ et al. [56] Surgisis Surgisis (90 days)
47
47
360

⊡ Table 47.1. Continued

Year Author Animal N Meshes Open / lap Fewer adhesions More adhesions Time

2006 Sikkink et al. [31] Rats 60 PP (Prolene) Open Sepramesh PP (Prolene) 2 months
PP (Prolene) + Hyalobar-
rier gel
PP (Prolene) + Tissucol
ePTFE (DualMesh)
Sepramesh
Parietene Composite

2006 Dilege et al. [57] Rats 30 PP (Prolene) Open PP + Interceed PP (Prolene) 28 days
PP + Interceed Sepramesh
Sepramesh

2006 Burger et al. [32] Rats 200 PP (Prolene) Open Sepramesh 7 and 30 days
ePTFE (DualMesh) Parietex Composite
Ultrapro
Timesh
Sepramesh
Parietex Composite
Proceed
Tutomesh

2006 Harrell et al. [34] Rabbits 60 ePTFE (DualMesh) Sequential ePTFE (DualMesh) PP (Marlex) 16 weeks
Composix E/X lap
Proceed
Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

PP (Marlex)

2007 Kiudelis et al. [58] Rabbits 42 PP (Prolene) Open ePTFE Bard PP (Prolene) 30 days
Mersilene Proceed Mersilene
PP + Vicryl PP + Vicryl
ePTFE Bard
Proceed

2007 Jacob et al. [59] Pigs 10 Proceed Lap Parietex Composite PPL 28 days
Parietex Composite
PP

2007 Voskerician et al. [19] Rats cPTFE (MotifMESH) Open cPTFE (MotifMESH) PP (Marlex) 1 and 3 months
ePTFE (DualMesh) Composix
Composix
PP (Marlex)
▼ Proceed
2007 Novitsky et al. [18] Rabbits 20 PP (Marlex) Open ePTFE (DualMesh) PP (Marlex) 1 year
ePTFE (DualMesh)
Composix E/X
Proceed
2007 Bellón et al. [4] Rabbits 24 Parietex Composite Sequential Parietex Composite, Sepramesh 3, 7, and 14 days
Sepramesh lap PPL-PU 99
PP-PU 99
2008 Marcondes et al. [60] Rabbits 24 PP (Surgipro Mesh) Lap Sepramesh PP (Surgipro Mesh) 28 days
Sepramesh
Composix E/X
2008 Junge et al. [33] Rats 40 PVDF+PP (Dyna.Mesh) Open Parietene Composite PP 30 days
Parietene Composite
ePTFE (DualMesh)
PP
2008 Conze et al. [17] Rabbits co-PVDF Lap No differences No differences 7, 21, and 90 days
PP (Prolene)

 AlloDerm – Decellularized human dermis (LifeCell, Brachburg, NJ, USA)  Parietex Composite – Collagen-oxidized film-treated mesh (Sofradim, Trévoux, France)
 co-PVDF – Automanufactured mesh woven with PVDF polymer (Solvay, Brussels, Belgium)  Poloxamer – Triblock copolymers consisting of a central hydrophobic block of polyethy-
 Composix – Nonwoven ePTFE (Davol, Cranston, RI, USA) lene glycol flanked by two hydrophilic blocks of polyethylene glycol
 Composix E/X – PP mesh sewn with PP stitching to a thin sheet of ePTFE (Davol, Bard,  PolyesterComposite – Polyurethane-covered Dacron mesh (Braun, Melsungen, Ger-
Murray Hill, NJ, USA) many)
Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

 cPTFE (MotifMESH) – Nonwoven macroporous condensed PTFE (Proxy Biomedical, Gal-  PP (Marlex) – PP mesh (Bard, Murray Hill, NJ, USA)
way, Ireland)  PP (Surgipro) – Monofilament PP mesh (AutoSuture, Norwalk, CT, USA)
 ePTFE (CV-4) – Automanufactured mesh woven out of ePTFE suture thread CV-4 (Gore &  PP-PU 99 – Autodesigned prosthesis composed with a reticular PP mesh and a nonab-
Associates, Flagstaff, AZ, USA) sorbable 26-μm-thick polyurethane film
 ePTFE (DualMesh) – ePTFE (Gore & Associates, Flagstaff, AZ, USA)  Proceed – PP–polydioxanone composite with oxidated cellulose coating (Ethicon, So-
 ePTFE (STP) – Gore-Tex Soft Tissue Patch, ePTFE with two laminar microporous surfaces merville, NJ, USA)
(Gore & Associates, Flagstaff, AZ, USA).  Prolene – PP mesh (Ethicon, Somerville, NJ, USA)
 Fluorosoft – Fluoropassivated polyester (Sulzer Vascutek, Renfrewshire, Scotland)  PVDF + PP (DynaMesh) – Two-component (PP mesh and PVDF) monofilament mesh
 Gelfilm – Pharmacia & Upjohn, a subsidiary of Pharmacia, Kalamazoo, MI, USA (FEG Textiltechnik, Aachen, Germany)
 Hyalobarrier gel – Sterile, transparent, and highly viscous gel obtained by condensation  Seprafilm – Bioabsorbable translucent membrane composed of carboxymethylcellulose
of hyaluronic acid (Fidia Advanced Biopolymers SRL, Abano Terme, Padova, Italy) and hyaluronic acid (Genzyme, Cambridge, MA, USA)
 Icodextrine – Iso-osmolar biodegradable –1,4-linked glucose polymer solution (Extra-  Sepramesh – PP mesh coated on one side with a bioresorbable adhesion barrier (Sepra-
361

neal, Baxter Healthcare, Vienna, Austria) film; Genzyme, Cambridge, MA, USA)
 Interceed – Oxidized regenerated cellulose (Johnson & Johnson Medical, New Bruns-  Silastic – Polydimethylsiloxane prosthesis (Dow Corning, Midland, MI, USA)
wick, NJ, USA)  Surgipro Mesh – Single-layer PP mesh (U.S. Surgical, Norwalk, CT, USA)
 Lyo-dura – Lyophilized dura mater (Braun-Dexon, Barcelona, Spain)  Surgisis – Derived from porcine small intestine submucosa (Cook, Strombeek-Bever,
 Mersilene – Polyethylene terephthalate (Johnson & Johnson, Somerville, NJ, USA) Belgium)
 MycroMesh – ePTFE (Gore & Associates, Flagstaff, AZ, USA)  Tissucol – Fibrin glue (Baxter Healthcare, Vienna, Austria)
 Parietene Composite – PP mesh bonded on one side to a collagen-oxidized film (Sofra-  Vicryl – Polyglactin 910 (Johnson & Johnson, Somerville, NJ, USA)
dim, Trévoux, France)  Vipro II – PP/polyglactin 910 composite mesh (Johnson & Johnson, Somerville, NJ, USA)
47
362 Chapter 47 · Effect of Different Mesh Materials on Adhesion Formation

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abdominal wall reconstruction. Plast Reconstr Surg. Morales-Conde: No.


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2008;12(1):58–61

Discussion

Kukleta: Did you observe in the last study more


seromas because you completely sealed the space
between the mesh and the defect?
Morales-Conde: The amount of glue is not even
2 cc for a 15×19 mesh. We are injecting this ex-
tra glue inside the sac. We saw a decrease of the
seroma.
Klinge: You mentioned that the fixation is respon-
sible for the pain. What do you think about the
importance of elasticity?
Morales-Conde: You have to think about the elas-
ticity of the mesh and of the capsule around the
mesh. We do not have that data as we never mea-
sured the elasticity of the abdominal wall in the
pigs.
Klinge: I think it is not only the capsule, but the
ePTFE without the capsule is not elastic at all.
Gryska: I am glad to see you recognizing that the
tackers can cause pain. Do you have experience
with gluing only without tacks?
48

Tissue Ingrowth and Laparoscopic


Ventral Hernia Mesh Materials:
An Updated Review of the Literature
E. Honigsberg, D. Fowler, and B. Jacob
366 Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature

Introduction prevent recurrences. We can also evaluate which


mesh products will not withstand normal pres-
Laparoscopic ventral hernia repair (LVHR) is an sures and instead will require more permanent
accepted means of treating incisional and ventral fixation.
hernias and has been associated with a number of
benefits, including low wound infection rates, low
recurrence rates, low postoperative pain rates, and Physiology of Tissue Ingrowth
short hospital length of stay [1]. However, LVHR
requires the intraperitoneal placement of a mesh The optimal technique for mesh fixation to mini-
prosthesis, which can increase the risk of visceral mize hernia recurrence rates remains debatable
adhesion formation and its sequelae [2]. In addi- and often focuses on the types and number of
tion, there is a risk, although small, of recurrence sutures and tacks required [4]. In a porcine ca-
due to improper mesh fixation resulting from in- daver, the authors showed that the force required
adequate technique or inadequate adherence of the to disrupt a single transfascial suture was sig-
mesh to the abdominal wall. Therefore, mesh used nificantly greater than that required to disrupt a
for LVHR requires two unique properties: an anti- spiral tack (67 N vs. 28 N, p<0.001). Although
adhesive side to minimize adhesions to the viscera the strength of a tack or a suture is interesting,
and a side that optimizes tissue ingrowth to mini- the published conclusions on mesh fixation in
48 mize recurrence rates and mesh migration. The human clinical studies usually fail to evaluate the
demand for this optimal two-sided prosthetic for type of mesh used and that mesh’s ability to incite
LVHR has led to the research and development of tissue ingrowth from the peritoneal surface. The
a number of biomaterials specifically designed to mesh prostheses commonly used are known to
optimize adhesiveness to the peritoneum while de- be both chemically and physically biocompatible;
creasing adhesion formation to viscera. The focus however, they are not inert and instead induce a
of this review article is to provide an updated lit- multitude of host tissue responses, including tis-
erature review on the concept of fibrous ingrowth, sue ingrowth, that play a major role in a success-
also known as tissue ingrowth, as it relates to the ful LVHR [5].
use of two-layered mesh in LVHR. Tissue ingrowth likely begins within hours of
Baseline intraabdominal pressures (IAPs) have the establishment of contact between the mesh
previously been studied in healthy humans us- polymers and the peritoneal surface [5]. The initial
ing transduced pressures from transurethral blad- cellular events over the first 2 days are dictated
der catheters [3]. While the mean pressure in the by an acute inflammatory response. Leukocytes,
supine position was 1.8 mmHg, the mean pres- macrophages, and mast cells are released and ac-
sures for sitting and standing were 16.7mmHg and tivated. These inflammatory cells in turn release
20.0 mmHg, respectively. The average pressure for growth factors and cytokines. By the 3rd day, this
a cough was 107 mmHg. These are the estimated process has lead to early angiogenesis from the
pressures that an LVHR mesh would be exposed preexisting host microvasculature. Angiogenesis
to after insertion. Given the wide variety of mesh continues with the formation of capillary buds
products available for ventral hernia repairs, the and sprouts that grow into and around the mesh
authors hypothesized that learning these baseline filaments. These sprouts ultimately interconnect
IAP numbers could better direct the engineering with each other and form a well-perfused micro-
of mesh prosthetics and could arm surgeons with vascular network. This neovasculature is required
the minimum benchmark pressures that a hernia for the formation of granulation tissue, which in
repair needs to withstand to avoid recurrence. turn leads to incorporation of the mesh into native
By studying the strength of tissue ingrowth tissue. After a period of only 2 weeks, the tissue
into the various mesh products, we can better incorporation of the mesh implants continues on a
understand which materials can generate enough path of collagen synthesis similar to that found in
ingrowth to stand up to daily IAPs and ultimately wound healing [5].
Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials
367 48
Animal studies have helped show that the tis- with loose scar tissue consisting mostly of mac-
sue ingrowth begins early and increases in strength rophages. Collagen fibers and strong evidence
over time. In a porcine laparoscopic ventral hernia of angiogenesis were not readily visible on the
model, Majercik et al. [6] demonstrated that the ePTFE until 2 months after implantation, and by
bulk of tissue ingrowth occurs during the first 3 months postimplantation, the connective tissue
2 weeks after a polypropylene mesh is inserted, and was substantial and the cell population had stabi-
by 4 weeks the strength of the ingrowth has already lized, consisting of mostly fibroblasts. In contrast
reached a strength equivalent to 95% of the peak to the ePTFE, the polypropylene mesh demon-
strength seen at 12 weeks [6]. By fixing sheets of strated complete integration into the host tissue.
polypropylene/expanded polytetrafluoroethylene The process of angiogenesis began within the first
(ePTFE) composite mesh to the abdominal walls 2 weeks in the polypropylene mesh, and cells were
and then harvesting them at different time inter- distributed within the interstices of the mesh. The
vals (2, 4, 6, and 12 weeks), the authors were able authors concluded that polypropylene incited a
to demonstrate a peel strength of 0.83 lb at 2 weeks, more intense inflammatory foreign body reaction
1.06 lb at 4 weeks, and 1.13 lb at 12 weeks (5 N). and had superior tissue integration, and therefore
Histologic examination of specimens showed com- that ePTFE was more suitable for implantation
plete cellular infiltration into and through the en- intraperitoneally, where it would be exposed to the
tire layer of the polypropylene up to the ePTFE viscera, and polypropylene was better suited for
layer. This study, which looked at the peel strength tissue integration [7].
of the polypropylene layer used in a heavyweight After the development of two-sided (compos-
polypropylene/ePTFE composite mesh, concluded ite) mesh products, this variability of tissue inte-
that the bulk of tissue ingrowth happens during gration among various mesh prostheses was again
the first 2 weeks after implantation. At 4 weeks, the demonstrated in a laparoscopic porcine model that
strength then increases to a value that is equivalent specifically looked at the tissue integration of the
to 95% of the peak strength measured at 12 weeks same materials (polypropylene and ePTFE) but
postimplantation. in a two-sided mesh material [8]. By fixing sheets
It is now well accepted that this tissue in- of pure two-sided ePTFE mesh and of a heavy-
growth provides long-term adhesive strength to weight polypropylene/ePTFE composite mesh to
the mesh. Interestingly, not all biomaterials are the abdominal wall in a porcine model, the authors
equally incorporated into native tissue by this were able to study the differences in the strength
cellular phenomenon. As early as 1995, Bellón et of tissue attachment to the two different materi-
al. published results that compared the cellular als. Again, the meshes were evaluated at different
response to, and subsequent tissue integration of, time intervals (2, 4, 6, and 12 weeks). The results
two different mesh prostheses in a rabbit model showed that the strength of tissue ingrowth was
[7]. At the time, the two leading products were significantly higher for the polypropylene com-
made of only one material and were heavyweight posite graft relative to the strength of ingrowth
polypropylene and pure ePTFE. The authors sus- into the pure ePTFE material at each time point.
pected that the two materials incited different lev- For example, at 2, 4, and 12 weeks, the mean
els of inflammation and therefore implanted these peel strength for the ePTFE was 0.50 lb, 0.53 lb,
two meshes into the anterior abdominal wall of and 0.51 lb, respectively (0.51 lb equals 2.27 N).
rabbits, ensuring that each mesh was exposed to This was significantly less (p<0.05) than the peel
the peritoneal cavity. Necroscopy was performed strength of the polypropylene at 2, 4, and 12 weeks,
at 14, 30, 60, and 90 days. being 0.825 lb, 1.06 lb, and 1.12 lb, respectively
Microscopically, the host tissue response dif- (equivalent to 3.68 N, 4.70 N, and 5.0 N).
fered between the ePTFE and the polypropylene. The authors then looked at histology slides
At the 2-week point, the ePTFE was encapsulated, and found that at 2 weeks, the polypropylene com-
not infiltrated, with connective tissue, whereas ponent of the composite mesh was entirely in-
the polypropylene was infiltrated throughout filtrated with fibroblasts and inflammatory cells,
368 Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature

with collagen deposition occurring throughout the weight polypropylene has relatively poor long-
polypropylene. The macroporous abdominal wall term biocompatibility compared with lightweight
surface of the ePTFE, however, showed no cel- polypropylene and ePTFE. This poor biocompat-
lular penetration through the ePTFE at 2 weeks. ibility may lead to poor mesh compliance [9].
The macropores were filled with benign-appearing The compliance of the mesh implants may
tissue, but no collagen deposition had occurred. change over time; the thicker the scar plate for-
There were obvious differences in the histologic mation that results from the fibrous ingrowth,
reaction and peel strengths between the different the less compliant the mesh may be in long-term
biomaterials, suggesting that tissue ingrowth and follow-up. Without a compliant mesh prosthesis,
peel strength were superior for the polypropyl- the abdominal wall can become less pliable, and
ene layer of the polypropylene/ePTFE compos- clinically this may result in physical discomfort,
ite mesh compared with a pure ePTFE material limitations in daily activities, and overall dissat-
against the peritoneum [8]. isfaction. The group from Charlotte, North Caro-
The tissue ingrowth maturation process for lina, performed a rabbit comparison study and
the polypropylene seems to reach 74% of its within that study reported on mesh compliance
maximum by 2 weeks and 95% of its maximum 1 year after implantation [10]. Using a differenti-
by 4 weeks. Thus, the strength plateaus after a ated variable reluctance transducer (DVRT) that
12-week period of time in animal studies; how- provided measurements of the axial forces re-
48 ever, there may be evidence that cellular turn- quired to stretch the mesh, the group reported
over continues for up to a year, and the severity compliance data on pure polypropylene, a com-
of the continuing process may depend on the posite mesh of polypropylene and ePTFE, pure
type of mesh implanted. This degree of inflam- ePTFE, and a composite of lightweight polypro-
mation produced in response to various LVHR pylene and an oxidized cellulose layer. At 1 year,
mesh products has recently been studied using they showed that the compliance of the pure
immunohistochemical testing for Ki-67, which two-sided ePTFE mesh was superior to that of the
is an accepted and established marker of cell other three meshes.
proliferation and turnover [9]. In a rabbit study Interestingly, using the same DVRT method to
that compared tissue ingrowth analysis between then analyze the peel strength of the mesh products,
a control of polypropylene and three mesh prod- the group did not demonstrate a significant differ-
ucts–a heavyweight polypropylene/ePTFE com- ence in peel strength among those four materials,
posite mesh (hPP), pure ePTFE, and a reduced- although the heavyweight polypropylene/ePTFE
weight polypropylene/oxidized regenerated cel- composite trended toward having the greatest peel
lulose composite mesh (rPP)–the authors looked strength. A number of rabbit studies published by
at results 4 months and 12 months postimplanta- the same group showed no significant differences
tion. They found that the hPP mesh group had in tissue ingrowth among ePTFE, lightweight poly-
significantly higher Ki-67 levels than the rPP propylene composite mesh, and heavyweight poly-
and ePTFE groups at 4 months. At 12 months, propylene composite mesh [10–12]. This finding
a significant decrease in Ki-67 scores from the is not consistent with other published rabbit and
4-month point was found in the rPP group only, porcine studies that compared the same products
while the hPP group maintained elevated levels of [8, 13], and it may be related to factors such as the
Ki-67. This interesting finding suggests that the type of animal model used and the method of ob-
heavyweight polypropylene-based mesh material taining and calculating the peel strength.
incites an ongoing inflammatory process and scar In conclusion, while the polypropylene-based
remodeling that lasts even 1 year later. This find- mesh materials show superior tissue ingrowth and
ing was not seen with the lightweight polypropyl- superior peel strengths that may result in fewer re-
ene product or with the pure ePTFE. The way this currences, the long-term compliance of the mate-
finding would translate into a human clinical set- rial suffers, and this may have clinical sequelae yet
ting is unknown, but it may suggest that heavy- to be discovered.
Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials
369 48
Mesh Prostheses in Laparoscopic surface (>100 μm) on the peritoneal side. This
Ventral Hernia Repair macroporous surface was engineered to encourage
maximal tissue ingrowth into a material originally
Laparoscopic ventral hernia mesh is probably designed to minimize inflammatory responses.
best described as a foreign body, and it therefore The different mesh products can also be classi-
will be associated with a lifelong risk of potential fied according to the physical properties of poros-
adverse host reactions [14]. Thus, it is important ity and pore size [16]. Macroporous meshes, such
to understand the different biomaterials currently as polypropylene and polyester, have pores >75 μm,
available in meshes designed for placement within whereas microporous mesh such as ePTFE has
the abdominal cavity, along with the different reac- pores <10 μm in at least one dimension. The larger
tions they incite when placed intraabdominally. In pore size permits infiltration by macrophages, fi-
this review we will focus on polypropylene, polyes- broblasts, blood vessels, and collagen fibers, al-
ter, and ePTFE, the three major materials used on lowing for elimination of bacteria and rapid tis-
the peritoneal surface of these two-layered meshes. sue ingrowth. Macroporous mesh quickly becomes
A discussion of the newer bioabsorbable mesh ma- fixed to tissue, whereas mesh with smaller pores
terials is beyond the scope of this paper and can be limits cellular infiltration and subsequent tissue
found in a more detailed review [15]. ingrowth [18]. A similar result was reported by
In 1958, Francis Usher introduced polypropyl- Klinge et al. in a rat model [19]. They found that
ene mesh to the field of inguinal hernia repair [16]. large-pore mesh was integrated in a loose net-
Since then, polypropylene has become the most work of perifilamentary granulomas, leading to
frequently used mesh worldwide, and both heavy- improved integration and significantly less ongo-
weight and lightweight polypropylene meshes are ing inflammatory response, whereas smaller-pore
in use [15]. Polypropylene is hydrophobic and con- mesh was embedded only into granulomas, and
sists of a carbon backbone with alternating methyl the scar tissue bridged the whole small pore, lead-
and hydrogen groups attached to the carbon chain. ing to less integration and intense ongoing chronic
It has been reported that in the long term, polypro- inflammation. Their conclusions helped show the
pylene may be subject to oxidation, which in time advantages of a large-pore mesh material.
can change the compliance of the mesh material In addition to porosity, the structure of the
[17]. In addition to polypropylene, polyester has biomaterial plays a key role in the tissue reaction
been widely used, and both two-dimensional (2D) to the prosthesis. Using a rabbit model, Bellón et
and three-dimensional (3D) polyester meshes are al. compared pure ePTFE in a laminar configura-
available. Theoretically, a 3D weave provides more tion with a novel composite ePTFE made of the
scaffolding for tissue ingrowth. Polyester is a hy- same laminar layer but sewn to a reticular, wo-
drophilic, carbon-based polymer that forms strong ven parietal layer made of woven ePTFE suture
fibers and, unlike polypropylene, has been shown [20]. This allowed the authors to study ingrowth
to resist oxidation [17]. If placed extraperitoneally, differences between laminar ePTFE and reticular
either of these meshes can provide terrific tissue (or woven) ePTFE. The results showed that after
ingrowth; however, in LVHR the mesh must be 14 days, the laminar mesh was encapsulated on its
placed intraperitoneally. Because of the significant subcutaneous aspect by dense scar tissue. Fibro-
cellular ingrowth that these meshes incite, neither blasts, macrophages, and other leukocytes were
polypropylene nor polyester should be used intra- present but colonized only the outer third of the
peritoneally, where they would be directly exposed ePTFE sheet. Its visceral layer was associated with
to the surface of the bowel. Instead, ePTFE is the a highly organized, thick neoperitoneum consist-
initial material that is safe to place against exposed ing of connective tissue arranged in an even, par-
bowel [15]. It consists of a long carbon chain with allel fashion. The reticular composite mesh had
two side fluorine atoms per carbon. The two-sided a similar result for its laminar surface, but the
mesh of ePTFE has a microporous surface (3 μm reticular surface was embedded in dense repair
wide) on the visceral side and a macroporous tissue and demonstrated superior tissue ingrowth.
370 Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature

⊡ Table 48.1. Commercially available two-layered mesh (ePTFE expanded polytetrafluoroethylene)

Composite mesh Visceral layer Parietal layer

DualMesh Microporous ePTFE Macroporous ePTFE


(Gore)

Proceed Surgical Mesh Oxidized, regenerated cellulose Reduced-weight polypropylene


(Ethicon) (encapsulated with polydioxanone polymer)

Parietex Composite Antiadhesive collagen (solution of oxidized Three-dimensional polyester weave


(Covidien) bovine atelocollagen type I, polyethylene
glycol, and glycerol)

Sepramesh Cellulose (carboxymethylcellulose) Polypropylene


(Genzyme)

C-Qur Omega-3 fatty acid bioabsorbable coating ProLite Ultra polypropylene


(Atrium)

Composix E/X Microporous PTFE Standard heavyweight polypropylene


(Bard)

48
Inflammatory cells extensively infiltrated the re- mesh to heavyweight polypropylene/ePTFE and
ticular mesh filaments. As expected, with the use lightweight polypropylene/carboxymethylcellulose
of an Instron hydraulic-controlled tensiometer to composite meshes. In a majority of the rabbit
evaluate the peel strength of the tissue ingrowth, models, no significant difference in peel strength
the reticular mesh was significantly more adher- was found [9, 11], whereas in porcine models a
ent than the laminar mesh (26.75 N vs. 14.11 N, significant difference in peel strength was noted,
p<0.05) [20]. This finding shows that the type of favoring the adherent strength of the heavyweight
weave of the material, more so than the actual ma- polypropylene composite [8].
terial itself, is an important factor affecting tissue Recently, 3D polyester-based composite meshes
ingrowth strength. This discovery helped lead to have also been used more often. One such compos-
the engineering of a number of other »composite« ite mesh includes a 3D polyester parietal layer and
or two-sided meshes. an antiadhesive barrier made of a polyethylene gly-
The importance of both mesh porosity and col, glycerol, and collagen mixture on the visceral
spatial structure to tissue ingrowth led to the de- surface to prevent adhesions (Parietex Composite;
velopment of »second-generation« barrier meshes. Covidien, Norwalk, CT, USA). A number of ani-
A summary of the two-layered mesh commercially mal studies are available that compare it to other
available today is provided in ⊡ Table 48.1. leading mesh products currently in use [21–23].
In a porcine adhesiogenic laparoscopic ventral
hernia model, McGinty et al. compared the 3D
Fibrous Ingrowth in Animal Models polyester/antiadhesive collagen composite mesh
to the pure two-layered ePTFE mesh (DualMesh;
Because it is difficult to evaluate fibrous ingrowth Gore, Arizona), using heavyweight polypropylene
in patients who have undergone LVHR, several as a control [21]. After laparoscopic insertion and
studies have focused on comparing tissue ingrowth survival for 4 weeks, the peel strength of the mesh
in different types of mesh prostheses in adhe- from the abdominal wall was analyzed using a
siogenic rabbit or porcine laparoscopic ventral digital tensiometer and was found to be signifi-
hernia models. Several studies already mentioned cantly less for the pure ePTFE than for the poly-
in this chapter compared pure two-sided ePTFE ester/antiadhesive collagen composite mesh or the
Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials
371 48
pure polypropylene control (1.3 N/cm vs. 2.8 N/cm, ester/antiadhesive collagen composite mesh with
p=0.001, vs. 2.1 N/cm, p=0.05, respectively). His- another composite mesh of lightweight poly-
tologically there was excellent fibrous growth into propylene/carboxymethylcellulose (SepraMesh;
and through the polypropylene and the polyester Genzyme) [24]. As part of their evaluation, they
component of the composite mesh. There was no reported the strength of mesh incorporation by
tissue growth through the ePTFE. This finding sup- measuring the peel strength using an Instron 4502
ports the notion that complete tissue ingrowth can tensiometer (Instron) at two time points, 1 month
be found in a 3D polyester mesh and that this leads and 5 months. They showed that the peel strength
to superior adherence strength compared with the of the 3D polyester/antiadhesive collagen compos-
peel strength seen with pure two-sided ePTFE. ite mesh was superior to that of the lightweight
In another study, the 3D polyester/antiadhe- polypropylene/carboxymethylcellulose composite
sive collagen composite mesh was then compared mesh: 60.8 N vs. 42.6 N (p<0.001), respectively,
to a heavyweight polypropylene/ePTFE composite at 1 month and 70.9 N vs. 31.5 N (p<0.001) at
mesh (heavyweight polypropylene parietal layer) 5 months. In their rabbit model, the 3D polyester
[22]. The same porcine model was used. Again, product had superior ingrowth at both time points
a pure polypropylene mesh was used as a control. compared with the lightweight, nonencapsulated
While the study reported on a number of variables, polypropylene composite product.
regarding the issue of tissue ingrowth as measured Interestingly, most of the published animal
by the peel strength of the mesh from the abdomi- studies showed that the 3D polyester/antiadhe-
nal wall, the authors concluded that the polyester sive collagen composite mesh had significantly
composite product and the polypropylene compos- more tissue ingrowth than the pure ePTFE and
ite product were not significantly different regard- two different lightweight polypropylene products.
ing abdominal wall adherence. This result suggests However, the polyester composite mesh had no
that a 3D polyester mesh has fibrous ingrowth significant difference in peel strength compared
properties similar to those of polypropylene mesh. with the heavyweight polypropylene composite
In yet another prospective randomized study product. ⊡ Table 48.2 summarizes these extrapo-
using the same adhesiogenic porcine model, the lated peel-strength results from a select group of
3D polyester/antiadhesive collagen composite animal studies that reported at least 4 weeks of
mesh was compared to Proceed, a composite mesh follow-up and also compared tissue ingrowth data
made of lightweight polydioxanone-polymer-en- between two different mesh materials. Given such
capsulated polypropylene on the peritoneal surface terrific tissue ingrowth results for the 3D polyester
and oxidized regenerated cellulose as the antiad- composite mesh, as were also found for the heavy-
hesive barrier on the visceral surface [23]. Again, weight polypropylene composite mesh, one might
regular polypropylene was inserted as a control. be concerned about the long-term compliance of
After 1 month the mesh was harvested, and as part this material. But to date, not enough data suggest
of the evaluation, peak peel strength was measured that the compliance of the polyester composite
using a digital force gage tensiometer (Omega mesh changes significantly over time.
DFG51-10 microprocessor-based digital force
gage). The results showed that the peel strength
was significantly higher for the 3D polyester com- Shortcomings of the Animal
posite mesh than for the encapsulated lightweight Experiments
polypropylene composite mesh (17.2 N vs. 10.7 N,
respectively; p<0.002). The authors concluded that It is difficult to compare the tissue ingrowth re-
the 3D polyester composite mesh incited better sults among the different animal studies. For one,
tissue ingrowth than the lightweight encapsulated it is important to point out that the methods
polypropylene composite mesh. used to obtain the peel-strength force varied. In
In a rabbit animal study, Judge et al. found different studies, peel strength was obtained by
similar results when they compared the 3D poly- either a handheld microprocessor-based digital
372 Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature

⊡ Table 48.2. Extrapolated peel-strength results from a select group of animal studies
(ePTFE expanded polytetrafluoroethylene; NS not significant)

First Animal Weeks Mesh 1 Mesh 2 Peel strength, Peel strength, Reported
author model (parietal layer) (parietal layer) mesh 1 mesh 2 p-value

McGinty Porcine 4 Pure ePTFE Polyester 1.3 N/cm 2.8 N/cm p=0.001
[21] composite

Duffy [22] Porcine 4 Heavyweight Polyester 5.1 N 4.8 N NS


Polypropylene composite
composite

Jacob [23] Porcine 4 Lightweight, Polyester 10.7 N 17.2 N p<0.002


coated composite
polypropyl-
ene composite

Iannitti [8] Porcine 12 Pure ePTFE Heavyweight 0.51 lb (2.27 N) 1.12 lb (4.98 N) p<0.05
polypropylene
composite

Judge [24] Rabbit 4, 20 Lightweight, Polyester 42.6 N, 31.5 N 60.8 N, 70.9 N p<0.001,
48 uncoated composite p<0.001
polypropylene
composite

tensiometry [21–23] , a servohydraulic-controlled Some studies evaluated the mesh at 1 month, and
tensiometer made by Instron [8, 20], or a differ- others at a number of different time points up to
entiated variable reluctance transducer [9]. To our a year. Not shown in ⊡ Table 48.2 are the results
knowledge, none of these peel-strength measur- of the North Carolina group’s many rabbit studies
ing methods has been validated well, nor can the followed for up to a year, in which no significant
reported results of each method be compared with difference was found in the peel strength of the
one another. various mesh products they tested [9–12]. These
In addition to the different methods of obtain- findings that failed to show a difference in peel
ing peel strength, the studies vary in the type of strength may be attributable to factors related to
animal model used. Some of the studies used a the animal species used, the method of obtaining
rat or rabbit model and employed an open mesh the peel strength, or the time the mesh was left in
insertion technique, whereas other studies used place. Further, the results may not be reflective of
porcine models with either an open mesh insertion the behavior of the mesh in humans and are best
or a laparoscopic mesh insertion technique. Some used to compare mesh material.
of these models were »adhesiogenic,« and others As mentioned earlier, the baseline IAP in hu-
were not. If a mesh is inserted laparoscopically in mans when lying down, sitting, standing, and
an adhesiogenic animal model, it can be assumed coughing was shown in one study to be 1.8 mmHg,
that this would better represent the handling and 16.7 mmHg, 20.0 mmHg, and 107 mmHg, respec-
trauma that the material would be exposed to tively [1]. While these baseline values are pressure
during a human laparoscopic case. Some of the values reported in mmHg, as shown in this chapter,
models attempted to create a more adhesiogenic most of the tensile strength data (the force required
environment by abrading the small bowel [21–23], to separate, or peel, the mesh prosthetic from the
while other models did not [8–12]. tissue ingrowth formed on the peritoneal surface)
Finally, the length of time a mesh was left in situ are shear-force values and are reported in either
before being analyzed varies among the studies. pounds, newtons, or newtons per centimeter. Ac-
Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials
373 48
cording to standard physics conversion charts, a dominal wall. Both the 3D polyester composite
pressure value (such as mmHg) cannot be con- product and the heavyweight/ePTFE composite
verted directly to or from a shear-force value (such product have superior adherence strengths com-
as newtons). Instead, to our knowledge, the for- pared to reported results for the other materials.
mula of pressure = force/area (N/m2) would need That being stated, some evidence suggests that
to be employed. Therefore, the data reported in the heavyweight polypropylene composite prod-
most of these animal studies should be used only ucts incite long-term inflammatory changes and
to relatively compare the two or three mesh prod- even lose compliance over time, thus potentially
ucts within that particular study. The data should changing the long-term biocompatibility of that
probably not be extrapolated to make assumptions product. Long-term compliance results following
about whether those measured peel-strength forces the use of the polyester composite product are yet
are the same as the forces that would be required to to be reported.
withstand the normal IAPs of daily living. The development of composite meshes is based
on the important physiologic phenomenon of fi-
brous tissue ingrowth, which is a well-described
Conclusion cellular reaction to the placement of a mesh pros-
thesis. Many different animal studies illustrate well
Armed with the knowledge of the varying levels the varying levels of tissue ingrowth and the long-
of tissue ingrowth and peel strength of the differ- term results of that tissue ingrowth on the mesh
ent mesh products, the published clinical human material. The ideal mesh must incite minimal ad-
studies showing different recurrence rates may hesions on its visceral aspect while also inciting
make more sense. For instance, in a popular paper strong tissue ingrowth on its parietal surface and
published in 2003 that summarized a very large se- avoiding continuous long-term scar remodeling
ries of laparoscopic hernia repairs, Heniford et al. that may reduce its long-term biocompatibility.
reported a 4.7% recurrence rate after LVHR with
a pure ePTFE material [25]. Extrapolated in the
results is that approximately 20 of the 35 patients References
with recurrences experienced these recurrences
for »unknown reasons.« It is certainly feasible that 1. Cobb WS, Kercher KW, Heniford BT (2005) Laparoscopic
repair of incisional hernias. Surg Clin North Am 85:91–103
some of these reasons were related to lack of ad-
2. Leber GE, Garb JL, Alexander AI, Reed WP (1998) Long-
equate tissue ingrowth through the ePTFE; more term complications associated with prosthetic repair of
permanent fixation is often required for that type incisional hernias. Arch Surg 133:378
of mesh. Today, studies that neglect to comment 3. Cobb WS, Burns JM, Kercher KW, Matthews BD, Norton
on the mesh material and its inherent proper- HJ, Heniford BT (2005) Normal intraabdominal pressure in
healthy adults. J Surg Res 129:231–235
ties to incite tissue ingrowth may be overlooking
4. van’t Riet M, de Vos van Steenwijk PJ, Kleinrensink GJ,
an important early characteristic that reaches be- Steyerberg EW, Bonjer HJ (2002) Tensile strength of mesh
yond the importance of whether to use a tack or fixation methods in laparoscopic incisional hernia repairs.
a suture. Of course, the ability of a mesh to stay Surg Endosc 16:1713–1716
compliant over time may be just as important, if 5. Laschke MW, Häufel JM, Thorlacius H, Menger MD (2005)
New experimental approach to study host tissue re-
not more so; therefore, the optimal prosthetic may
sponse to surgical mesh materials in vivo. J Biomed Mater
still be debatable. Res A 74(4):696–704
As LVHR has become an accepted means of 6. Majercik S, Tsikitis V, Iannitti DA (2006) Strength of tissue
dealing with a common surgical problem, the pur- attachment to mesh after ventral hernia repair with syn-
suit of an »ideal« mesh for intraperitoneal place- thetic composite mesh in a porcine model. Surg Endosc
20(11):1671–1674
ment continues. Animal studies suggest that the
7. Bellón JM, Buján J, Contreras L, Hernando A (1995) Inte-
different materials available today incite varying gration of biomaterials implanted into abdominal wall:
levels of tissue ingrowth, which translates into process of scar formation and macrophage response.
varying levels of adherence strength to the ab- Biomaterials 16(5):381–387
374 Chapter 48 · Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature

8. Iannitti DA, Hope WW, Tsikitis V (2007) Strength of tissue devices in a porcine laparoscopic ventral hernia repair
attachment to composite and ePTFE grafts after ventral model. Hernia 8:358–364
hernia repair. JSLS 11(4):415–421 23. Jacob BP, Hogle NJ, Durak E, Kim T, Fowler DL (2007) Tis-
9. Novitsky YW, Cristiano JA, Harrell AG, Newcomb W, sue ingrowth and bowel adhesion formation in an animal
Norton JH, Kercher KW, Heniford BT (2008) Immunohis- comparative study: polypropylene versus Proceed versus
tochemical analysis of host reaction to heavyweight-, Parietex Composite. Surg Endosc 21(4):629–633
reduced-weight, and expanded polytetrafluoroethylene 24. Judge TW, Parker DM, Dinsmore RC (2007) Abdominal
(ePTFE)-based meshes after short-and long-term intraab- wall hernia repair: a comparison of Sepramesh and Pari-
dominal implantations. Surg Endosc 22:1070–1076 etex Composite mesh in a rabbit hernia model. J Am Coll
10. Novitsky YW, Harrell AG, Cristiano JA, Paton BL, Norton Surg 204(2):276–281
HJ, Peindl RD, Kercher KW, Heniford BT (2007) Compara- 25. Heniford BT, Park A, Ramshaw BJ, Voeller G (2003) Lap-
tive evaluation of adhesion formation, strength of in- aroscopic repair of ventral hernias: nine years’ experience
growth, and textile properties of prosthetic meshes after with 850 consecutive hernias. Ann Surg 238(3):391–400
long-term intra-abdominal implantation in a rabbit. J
Surg Res 140(1):6–11
11. Matthews BD, Mostafa F, Carbonell AM, Joels CS, Kercher
KW, Austin C, Norton HJ, Heniford BT (2005) Evaluation
of adhesion formation and host tissue response to intra-
Discussion
abdominal polytetrafluoroethylene mesh and composite
prosthetic mesh. J Surg Res 123:227–234 Deysine: How could you standardize the opera-
12. Harrell AG, Novitsky YW, Cristiano JA, Gersin KS, Norton tion? Were there histologic proofs of the peritoneal
48 HJ, Kercher KW, Heniford BT (2007) Prospective histologic
defects?
evaluation of intra-abdominal prosthetics four months
after implantation in a rabbit model. Surg Endosc Jacob: No, we have no histology of the small in-
21(7):1170–1174 testine and the peritoneum. We had only the stan-
13. Greenawalt KE, Butler TJ, Rowe EA, Finneral AC, Garlick dardized adhesiolysis.
DS, Burns JW (2000) Evaluation of Sepramesh biosurgical Smeds: With regard to three-dimensional, is this
composite in a rabbit hernia model. J Surg Res 94:92
again a question of where we locate the prosthe-
14. Schumpelick V, Klinge U (2003). Prosthetic implants for
hernia repair. Br J Surg 90:1457–1458 sis?
15. Bachman S, Ramshaw B (2008) Prosthetic material in ven- Jacob: In this product, we think that there is
tral hernia repair: how do I choose? Surg Clin North Am. a difference between flat and three-dimensional
88(1):101–112 meshes. Is you look at electromicroscopy, you see
16. Amid PK (1997) Classification of biomaterials and their
differences in neovascularization.
related complications in abdominal wall hernia surgery.
Hernia 1: 15–21
Franz: You really have two studies going on within
17. Costello CR, Bachman SL, Ramshaw BJ (2007) Materials char- these experiments: one showing improved ab-
acterization of explanted polypropylene hernia meshes. J dominal wall ingrowth, breaking strength, and the
Biomed Mater Res B Appl Biomater 83B(1):44–49 reduced adhesion on the peritoneal surface. Have
18. Gonzalez R, Ramshaw BJ (2003) Comparison of tissue in- you thought whether they are related? Or do you
tegration between polyester and polypropylene prosthe-
ses in the preperitoneal space. Am Surg 69(6):471–476
have an idea what the mechanism may be?
19. Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze Jacob: I do not think they are related. I think that
J, Schumpelick V (2002) Impact of polymer pore size on the strong tissue ingrowth is a product of the mate-
the interface scar formation in a rat model. J Surg Res rial construction, perhaps even the three-dimen-
103:208–214 sional quality; it clearly has a stronger adherence.
20. Bellón JM, Rodríguez M, Serrano N, San-Martín AC, Buján
Whether or not this is clinically important to re-
J (2004) Improved biomechanical resistance using an
expanded polytetrafluoroethylene composite-structure duce recurrences we do not know. The companies’
prosthesis. World J Surg 28(5):461–465 task was to come up with the ideal mesh, maxi-
21. McGinty JJ, Hogle NJ, McCarthy H, Fowler DL (2005) A mize tissue ingrowth, and minimize adhesions. So
comparative study of adhesion formation and abdominal you can place the mesh intraperitoneally and feel
wall ingrowth after laparoscopic ventral hernia repair in a
comfortable. I really believe, at least based on these
porcine model using multiple types of mesh. Surg Endosc
19(6):786–790 small studies, that this has done that.
22. Duffy AJ, Hogle NJ, LaPerle KM, Fowler DL (2004) Com-
parison of two composite meshes using two fixation
49

Porosity and Adhesion


in an IPOM Model
J. Conze, M. Binnebösel, C. Krones
376 Chapter 49 · Porosity and Adhesion in an IPOM Model

As the advancing laparoscopic techniques for in- So far, none of the available meshes can claim
cisional hernia repair depend on meshes suitable to be completely antiadhesive. They can only re-
for direct contact with the intestine, the search duce the quantity and grade of adhesions with-
for the ideal mesh for intraabdominal placement out completely eliminating adhesion formation.
continues. In the last decade, much effort has been Kapische et al. analysed the literature and con-
put into the search for the perfect intraperitoneal cluded that there was no evidence demonstrating
onlay mesh (IPOM). The main problem in the the superiority of any of the available meshes for
investigation of meshes is the complexity of adhe- intraabdominal placement [5].
sion formation and the impossibility of measuring The experimental models for investigations are
this in the human body without further invasive limited and the transferability from animals to hu-
methods. Several meshes are available that pro- mans confined. Moreover, most animal models do
vide some sort of adhesion barrier, but for each not even mirror the clinical setting. These meshes
of these meshes we have found counterexamples are usually experimentally implanted in a full-
of dense adhesions in our daily clinical routine. In thickness wall defect using the mesh in an inlay
an experimental rat model investigating modern bridging technique. Today this technique has been
meshes for IPOM repair, Junge et al. found an ad- abandoned because of too many complications.
hesion area of more than 20% despite the kind of Another drawback is that studies often try to com-
adhesion barrier [4]. pare too many parameters within a single study. To
Meshes in the intraabdominal position must investigate the significance of a single factor, such
always maintain a balancing act between tissue– as pore size, the researchers should change only
49 mesh ingrowth on the parietal side of the perito- this single factor and nothing else.
neum and mesh protection on the visceral side We have developed a standardised experimen-
of the peritoneum. To address the problem of tal model in the rabbit to investigate the adhesive
adhesion formation, two different approaches have potential of intraabdominal mesh prostheses cor-
been followed to promote tissue ingrowth on the related with pore size [2, 3]. To study the adhesive
parietal side and to minimize the formation of potential of intraabdominal meshes, it is important
intestinal adhesions on the visceral side. to reduce other possible adhesive factors as much
One idea is the use of barriers involving physi- as possible. One of the major factors is surgical
cochemical pretreatment of a prosthesis, with the trauma; therefore, the meshes were placed by a
aim of creating an interface between the bioma- minimally invasive laparoscopic technique. The
terial and its areas of contact. The pioneer of laparoscopic incisions were placed in the lower
this idea was Chevrel in 1982, when he placed a abdomen, with the mesh placed in the upper abdo-
polyglactin mesh between the mesh and the in- men, far away from the incisions. The systematic
testine. Since then, many different materials have approach was realised by always changing only
been introduced to reduce the adhesive potential one of the textile parameters in one experimental
and to optimize the fibrocollagenous ingrowth, line. Textile parameters that need to be considered
including carboxymethylcellulose, amnion mem- are the polymer (polypropylene, polyester, ePTFE,
brane, phospholipids, hyaluronic acid, collagen, PVDF), the filament diameter, the construction
and many more. (monofilament or multifilament), and the pore
The other approach is the use of a composite size (⊡ Fig. 49.1).
mesh made of several components, one of which is Pore size has become one of the most im-
designed to attenuate or even abolish the adhesion portant parameters in the world of lightweight,
formation process on the visceral side and enhance large-pore meshes, first introduced by Klinge et al.
the fibrocollagenous ingrowth on the parietal side. in 1996 [7]. The foreign body reaction is character-
Typical combinations of these composite meshes ised by thickness of the perifilamental granuloma
include polypropylene with expanded polytetra- around the mesh fibre. The smaller the pore size
fluoroethylene (ePTFE) or polyvinylidene fluoride and the more pronounced the granuloma that
(PVDF). develops, the more likely a bridging of these neigh-
Chapter 49 · Porosity and Adhesion in an IPOM Model
377 49

polymer Filament size Filament construction Pore size

Tensile strength Elasticity Weight Surface Handling

Mesh complications
⊡ Fig. 49.1. Textile parameters of
synthetic meshes for hernia repair
Adhesions Shrinkage Foreign body reaction and their influence on possible
complications

bouring granulomas will occur, leading to a scar foreign body granuloma to the in vitro porosity of
bridging. It seems that every polymer itself has meshes, the »effective porosity« can be defined.
its own bridging distance, e.g. polypropylene has Surgeons today must choose from more than
a bridging distance of approximately 1,000 μm. 100 available hernia meshes. But mesh technol-
Polypropylene mesh prostheses with a pore size ogy has become a scientific world of its own, with
below 1,000 μm will inevitably lead to a complete a terminology of its own. Many parameters have
fibrocollagenous incorporation with a strong scar an impact on the biocompatibility. The only at-
plate formation. tempt at an internationally accepted classification
Today there is some confusion due to mixing of meshes was undertaken by Amid back in 1997,
up of the terms »lightweight mesh« and »large when the large-pore group was represented by
pore.« Not every large-pore mesh is a lightweight Marlex [1]. But today the large-pore meshes have
mesh, and not every lightweight mesh is a large- a pore size of up to 3,000 μm. Furthermore, we
pore mesh. This was well shown by Weyhe et al., now have new mesh polymers, such as PVDF, with
who compared a heavyweight polypropylene mesh a monofilament structure but a molecular weight
with a lightweight polypropylene mesh, observ- much higher than polypropylene–heavyweight
ing impaired biocompatibility for the lightweight meshes independent of the pore size.
mesh due to its microporous construction [9]. A There is no longer any reason to classify meshes
pore size smaller than 200 μm is almost watertight; by their weight. What seems more important is the
above 200 μm, neovascularisation becomes possi- amount of contact area between the mesh and the
ble, and only a pore size of more than 500–600 μm host tissue surface. A multifilament mesh con-
allows ingrowth of soft tissue. The extent of fibro- struction increases the mesh surface by a factor
collagenous bridging has an impact of the quality of 1.57 [6]. Enlargement of the pore size leads to
of the scar and its possible tissue contraction and a reduction in total filament length and, therefore,
subsequent mesh area shrinkage. less mesh surface. There seems to be a correla-
Therefore, it is no longer sufficient to reduce tion between pore size/surface area and adhesive
the description of meshes to weight alone. The potential. In our standardised IPOM rabbit model,
pore size or, more precisely, the porosity of meshes we placed pure polypropylene meshes of three dif-
is relevant for the biocompatibility in the host tis- ferent pore sizes (0.6 mm, 2.5 mm, and 3.5mm) in-
sue. Mesh porosity can be defined as a parameter traabdominally by laparoscopy. We then measured
that provides the polymer-free space for tissue the amount of adhesion formation by planimetry
ingrowth. Muhl et al. have recently published a and evaluated the adhesions with a specific score
method to objectively measure the porosity of tex- after 7, 21, and 90 days. We found a significant
tile implants by an image analysis system, objecti- difference in the degree of adhesion area and ad-
fying in two dimensions the pores’ structure and hesion score between the two large-pore mesh
geometry [8]. This enables more empirical charac- constructions and the small-pore mesh for all time
terisation of meshes. By adding the perifilamental points (⊡ Table 49.1).
378 Chapter 49 · Porosity and Adhesion in an IPOM Model

⊡ Table 49.1. Influence of pore size (0.6 mm, 2.5 mm, 3.5 mm) on adhesion formation after 7, 21, and 90 days in a rabbit
model of laparoscopic intraperitoneal onlay mesh repair (PP polypropylene)

Planimetry (mm²) Score

n Mean SD Min Max n Mean SD Min Max

Material Days 5 1,121.7* 600.8 513.1 1,869.4 5 7.0* 2.0 5.0 9.0

PP 0.6 7

21 5 1,111.8* 484.9 568.8 1,696.5 5 7.8* 1.3 6.0 9.0

90 4 869.0* 499.8 396.2 1,538.5 4 7.5* 1.3 6.0 9.0

PP 2.5 7 5 244.2 135.4 125.1 410.4 5 3.0 0.0 3.0 3.0

21 5 351.9 190.9 45.8 565.7 5 3.0 0.0 3.0 3.0

90 5 141.6 112.0 0.0 307.1 5 2.4 1.3 0.0 3.0

PP 3.5 7 6 479.1 343.9 84.9 1,020.5 6 4.2 1.3 3.0 6.0

21 6 306.9 294.8 14.4 835.3 6 3.8 1.0 3. 5.0

90 5 4.9 10.9 0.0 24.4 5 0.6 1.3 0.0 3.0

49
It seems obvious that we need a new termi- tion of a polyvinylidenfluoride/polypropylene mesh for
nology for modern meshes. Not all lightweight intra-abdominal placement in a rodent animal model.
Surg Endosc 23:327–333
meshes are lightweight meshes! A new parameter
5. Kapischke M, Schulz T, Schipper T, Tensfeldt J, Caliebe A
to differentiate hernia meshes should consider the (2008) Open versus laparoscopic incisional hernia repair:
mesh surface area and the effective porosity. The something different from a meta-analysis. Surg Endosc
influence of mesh construction (filaments, pore 22:2251–2260
size, geometry) is probably more important than 6. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B,
Schumpelick V (2002) Do multifilament alloplastic mes-
the polymer itself. In the experimental setting,
hes increase the infection rate? Analysis of the polymeric
minimal-surface, large-pore meshes have shown a surface, the bacteria adherence, and the in vivo conse-
reduced adhesive potential. Further studies should quences in a rat model. J Biomed Mater Res 63:765–771
focus on the right balance between fibrocollag- 7. Klinge U, Klosterhalfen B, Conze J, Limberg W, Obolenski
enous ingrowth and adhesion formation. B, Ottinger AP, Schumpelick V (1998) Modified mesh for
hernia repair that is adapted to the physiology of the
abdominal wall. Eur J Surg 164:951–960
8. Muhl T, Binnebosel M, Klinge U, Goedderz T (2008) New
References objective measurement to characterize the porosity of
textile implants. J Biomed Mater Res B Appl Biomater
1. Amid PK (1997) Classification of biomaterials and their 84:176–183
related complications in abdominal wall hernia surgery. 9. Weyhe D, Belyaev O, Muller C, Meurer K, Bauer KH, Papa-
Hernia 1:15–21 postolou G, Uhl W (2007) Improving outcomes in hernia
2. Conze J, Junge K, Klinge U, Weiss C, Polivoda M, Oettinger repair by the use of light meshes–a comparison of diffe-
AP, Schumpelick V (2005) Intraabdominal adhesion for- rent implant constructions based on a critical appraisal of
mation of polypropylene mesh. Influence of coverage of the literature. World J Surg 31:234–244
omentum and polyglactin. Surg Endosc 19:798–803
3. Conze J, Rosch R, Klinge U, Weiss C, Anurov M, Titkowa
S, Oettinger A, Schumpelick V (2004) Polypropylene in
Discussion
the intra-abdominal position: influence of pore size and
surface area. Hernia 8:365–372
4. Junge K, Binnebosel M, Rosch R, Jansen M, Kammer D, Deysine: I think we have not done enough investi-
Otto J, Schumpelick V, Klinge U (2009) Adhesion forma- gations about the capacity of collagen to contract.
Chapter 49 · Porosity and Adhesion in an IPOM Model
379 49
Conze: We have some data about the correlation of
foreign body reaction and shrinkage. The stronger
the foreign body reaction, the more shrinkage we
see.
Fitzgibbons: Don’t you think the reason why peo-
ple stick to ePTFE is because it has a long track
record? We have all these new adhesion barrier
materials now, but these materials are going to
break down; we will see the same problems as with
polypropylene. That is why the U.S. surgeons are
reluctant to move away from ePTFE.
Miserez: I have three questions: first, is there a
relationship between elasticity and pore size? Sec-
ond, how would monofilament polyester react?
Third, is there also a maximum size of the pores?
Conze: I have three answers: first, we have no idea
about the in vivo elasticity but I think the pore
size is of great importance. Second, again, it is just
a question of pore size. Monofilament polyester
with a large pore size could be a good material as
well. Third, that is a wonderful question! We saw
deformation and folding with 6-mm pore size in
mesh modifications – that was probably too much.
It depends on the memory effect of the mesh.
Schumpelick: Is it justified to make a two-dimen-
sional definition of porosity? Because we need a
definition for the three-dimensional meshes.
Conze: Yes, you are right.
50

Benefit of Lightweight and/or Titanium


Meshes?
C. Schug-Paß, F. Köckerling
382 Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?

Introduction 1. DualMesh (Gore) is made of ePTFE. This is a


membrane-like prosthesis with a smooth and
Despite numerous experimental investigations, the a rough surface. The ePTFE meshes are tradi-
search for an ideal mesh for laparoscopic intrap- tionally used for the intraabdominal position.
eritoneal use still has not concluded. Numerous 2. TiMesh Light (GfE Medizintechnik) is made
experiments, mainly conducted on open small ani- of a monofilament lightweight (35 g/m2) and
mal models, have demonstrated the advantages of large-pore (diameter about 1 mm) polypropyl-
meshes coated with absorbable materials, among ene mesh, which is titanium coated (thickness
other things. But what are the characteristics of an about 30 nm). This coating makes the mesh hy-
ideal intraperitoneal mesh? If we consider techni- drophilic and easy to place in the right position.
cal aspects, laparoscopic handling of the mesh
should be easy and safe. Meshes should have a per- Second Experiment
manent stability, but also a defined elasticity, and Three different composite meshes, all 10×15 cm,
they should resist infection. On the parietal side, were implanted. All meshes consisted of a basic
the abdominal wall flexibility should be preserved. structure made of a monofilament polypropylene
Maximal biocompatibility–that is, good integra- material in combination with various antiadhesive
tion into the surrounding tissue, with minimal components:
chronic inflammatory reaction–and minimal mesh 1. DynaMesh IPOM (Dahlhausen Medizintech-
shrinkage, as well as low formation of adhesions to nik) is a highly elastic polypropylene mesh
intestinal structures, are required. (28% at 32 N/cm) that is interwoven with a
We know that heavyweight meshes with a polyvinylidene fluoride (PVDF) thread on
small pore size as well as polyester meshes induce the visceral side. Based on the manufacturer’s
a strong inflammatory reaction with scar forma- information, this material is endowed with an-
50 tion and, therefore, reduction in elasticity of the tiadhesive properties. The total weight of the
abdominal wall. The development of lightweight, mesh was 108 g/m2.
large-pore, and monofilament polypropylene 2. Proceed (Ethicon) consists of a polypropylene
meshes led to a reduction in chronic inflammation mesh (44 g/m2) and an absorbable coating
and minimized the amount and strength of adhe- made of PDS (polydioxanone) and Interceed
sions to intestinal structures [1–3]. By comparing (cellulose), with an absorption time of around
composite meshes in a laparoscopic pig model, 4 months.
McGinty et al. showed collagen-coated polyester 3. Parietene Composite (Covidien Healthcare )
mesh (Parietex composite) to be the best biocom- is a polypropylene mesh (73 g/m2) coated with
patible mesh so far, with good tissue integration an absorbable film made of collagen, polyeth-
on one hand and only small adhesions to intesti- ylene glycol, and glycerol. This is absorbed
nal structures on the other hand; this mesh was after 2–3 weeks.
compared with a heavyweight polypropylene mesh
and the DualMesh prosthesis made of expanded
polytetrafluoroethylene (ePTFE) for intraabdomi- Experimental Pig Model
nal use [4].
A laparoscopic porcine model, which was officially
approved in accordance with the animal protec-
Materials and Methods tion law, was used for comparing different meshes
for intraabdominal use. Six pigs in each group
Technical Data on the Meshes were operated upon. The average weight of these
animals was 28 kg. Meshes were prepared with
First Experiment 10 1/0-ply polypropylene threads, and in the case
Two different types of mesh were implanted, all of of ePTFE, with 10 one-ply ePTFE threads. The
them 10×15 cm: implantation was accomplished using one 12-mm
Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?
383 50
and two 5-mm optic trocars. Meshes were intro-
duced into the abdominal cavity via the 12-mm
trocar, positioned in the middle/upper abdomen.
They were then fixed with transfascial sutures.
After 3 (first experiment) or 4 months (second
experiment), the animals were sacrificed. A di-
agnostic laparoscopy was performed. Afterwards,
the whole mesh, including the surrounding tissue,
was removed. Adhesion areas and the dimensions
of the mesh were measured in the fresh specimen.
The data were entered into the computer and sub-
mitted for planimetric analysis. a

Histology

Five specimens of each mesh were taken. After


fixation in formaldehyde, they were prepared with
different staining methods to analyse the partial
volume of inflammatory cells and the proportion
of macrophages, monocytes, and T-lymphocytes.
The apoptotic index was determined by immuno-
histochemistry with the aid of in situ end-labelling.
For quantification of the extent of cell prolifera-
tion, the sections were incubated with the antibody
b
Ki67. The morphometric analysis was performed
at the interface within a distance of 300 μm of the
⊡ Fig. 50.1. Results of first experiment. a The greater omen-
filament. tum adhered in a discrete manner to all implants (except for
one DualMesh case). b Titanium-coated meshes were in good
contact with the tissue and revealed little folding
Statistics

Graphic and statistical analysis was performed omentum adhered in a discrete manner to all im-
with the SPSS 14.0 statistical program. The results plants (⊡ Fig. 50.1a). In all cases, sharp dissection
were presented as mean values and standard devia- was needed to separate the omentum from the
tions. Statistical analysis (analysis of variance) was mesh surface. In particular, in the group receiv-
carried out to determine significance levels, show- ing DualMesh, shrinkage as a result of folding was
ing statistical significance for p-values <0.05. already evident at laparoscopy and was even more
evident in the explanted specimen, whereas the
titanium-coated meshes were in good contact with
Results the tissue and revealed little folding (⊡ Fig. 50.1b).
On macroscopic inspection, the meshes were cov-
First Experiment ered with a shiny layer in the adhesion-free areas,
but the underlying layer differed in consistency on
Macroscopic Results palpation. This induration was particularly seen
In none of the cases did the diagnostic laparos- with the PTFE implants.
copy reveal adhesions to the small bowel. With The morphometric evaluation of the preopera-
the exception of one case (DualMesh), the greater tive and postoperative mesh dimensions revealed a
384 Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?

Planimetric data
100%

90% Shrinkage
Adhesions
80%

70%

60%

50%

40% a
43%
30%

20%
23%
10% 20%
9%
0%
TiMesh light DualMesh

⊡ Fig. 50.2. Macroscopic results of first experiment

50
significantly smaller contact area for the DualMesh,
due in the first instance to the pronounced folding b
of the mesh. In contrast to the titanium-coated
polypropylene mesh, the remaining mesh area was ⊡ Fig. 50.3. Results of first experiment. a The polypropyle-
almost one-half of the initial area (57.0±13.1%). ne meshes were firmly integrated within the surrounding
The mean area of the titanium-coated mesh was tissue, with only mild scar formation and formation of a
neoperitoneum, with each individual fibre being surrounded
80.0±4.1% (p=0.006; ⊡ Fig. 50.2).
by connective tissue. b The polytetrafluoroethylene meshes
The area of adhesions to the greater omentum were embedded within scar tissue, and a strong inflammatory
was smaller for the titanium-coated polypropyl- reaction was seen. The connective tissue fibres were mainly
ene mesh–on average, 9.0±5.4%–compared with arranged in parallel
23.2±13.8% for the DualMesh, but because of a
high standard deviation, this was not significant
(p=0.055; ⊡ Fig. 50.2).
In the case of PTFE, the shrunken meshes
Histology and Immunohistochemistry were embedded within scar tissue, and a strong
The microscopic slides showed the polypropylene inflammatory reaction was seen. Owing to the
meshes firmly integrated within the surrounding small size of pores in the membrane, however, a
tissue, with only mild scar formation and for- permanent »through-growth« of connective tissue
mation of a neoperitoneum, with each individ- had not taken place, so there was no firm fixation
ual fibre being surrounded by connective tissue to the peritoneum. Rather, the picture was of an
(⊡ Fig. 50.3a). As a result, the connective tissue encapsulated membrane with additional calcifica-
structures were not always uniformly arranged. No tions also seen. As a result of the smooth surface
foreign body giant cells were seen in the vicinity of of the membrane, the connective tissue fibres were
the meshes. mainly arranged in parallel (⊡ Fig. 50.3b).
Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?
385 50
Histopathologic data
40
PV (% )
Ki 67 29.2
30
AI (% )

20.3
20
14
a
9.3
10 7.5
3.3

0
TiMesh light DualMesh

⊡ Fig. 50.4. Histopathologic results of first experiment (PV


partial volume of inflammatory cells; AI apoptotic index)

With regard to the partial volume of the in-


flammatory cells, the median figures were lowest
for TiMesh Light (20.3±2.1%) and were signifi- b
cantly higher for DualMesh (29.2±5.5%, p=0.009;
⊡ Fig. 50.4).
Investigations with the proliferation marker
Ki67, a sign of cell activity, again showed the
highest figures for DualMesh (14.0±3.9%), which
were thus also significantly higher than for TiMesh
(7.5±3.3%, p=0.011; ⊡ Fig. 50.4).
Finally, evaluation of the apoptotic index as a
sign of cell turnover with consecutive cell death
again revealed the highest figures for the ePTFE
membranes. The figure here was 9.3±2.5%, which
was again significantly higher than for the titanium-
coated polypropylene meshes (3.3±2.7%, p=0.002; c
⊡ Fig. 50.4).
⊡ Fig. 50.5a–c. Results of second experiment. More or less wi-
despread adhesions to the greater omentum were noted for
Second Experiment all meshes; these were often seen around the mesh margins

Macroscopic Results
In no case did laparoscopic diagnosis show any and its contact with the liver and spleen. More or
adhesions to the intestinal structures, but these less widespread adhesions to the greater omentum
were seen in some cases to the parenchymatous were noted for all meshes. These were often seen
organs depending on the position of the mesh around the mesh margins (⊡ Fig. 50.5a–c).
386 Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?

Adhesions

DualMesh 25.0%

TiMesh light 9.0%

Parietene Composite 12.8%

DynaMesh 33.2%

Proceed 31.6%
⊡ Fig. 50.6. Results of second
experiment: adhesions 0% 20% 40% 60% 80% 100%

Mesh surface at explantation

DualMesh 57.0%

TiMesh light 80.0%

Parietene Composite 86.0%


50
DynaMesh 85.0%

Proceed 75.0%
⊡ Fig. 50.7. Results of second experi-
ment: mesh surface at explantation 0% 20% 40% 60% 80% 100%

A reflecting surface, attesting to an intact neo- tigation. The greatest reduction in mesh surface
peritoneum, was observed in those areas of the full- was seen with Proceed (25.0±7.5%). This shrink-
wall specimens that did not harbour any adhesions. age was significantly higher than in DynaMesh
Only by resorting to sharp dissection was it possi- IPOM (14.2±7.1%, p=0.03) and was likewise sig-
ble to detach, in particular, the greater omentum in nificantly higher than in Parietene Composite
areas with adhesions. The density of adhesions did (14.0±8.6%, p=0.04), which produced comparable
not differ among the meshes. Parietene Composite values (⊡ Fig. 50.7). The results are summarised in
had the fewest adhesions. Planimetric analysis re- ⊡ Table 50.1.
vealed a 12.8±9% adhesion surface to the greater All meshes were completely integrated into the
omentum for Parietene Composite. As such, this abdominal wall.
was markedly less than that evidenced by Proceed,
but this finding was not significant (31.7±18.5%, Histology and Immunohistochemistry
p=0.06). Compared with DynaMesh IPOM, there Histology showed only minor signs of a chronic
was a significant difference (33.2±11.9%, p=0.01; inflammatory reaction. The polypropylene meshes
⊡ Fig. 50.6). were all well integrated into the surrounding tissue.
There was no evidence of any major fold- Formation of the neoperitoneum was complete in
ing in any of the meshes on macroscopic inves- the adhesion-free areas (⊡ Fig. 50.8a–c).
Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?
387 50
4.5±2.7%, than for Proceed (10.8±5.7%, p=0.04) and
were markedly, but not significantly, lower than for
DynaMesh IPOM (7.2±6.7%, p=0.4). The apoptotic
index, as a marker of cell death, was very low for
all meshes, and no significant differences were seen
(DynaMesh IPOM 1.2±0.4%, Proceed 1.5±0.8%,
Parietene Composite 1.7±0.8%; ⊡ Fig. 50.9).
Overall, Parietene Composite scored best in
the macroscopic as well as the histologic investiga-
tions. In terms of shrinkage of the mesh surface,
a the DynaMesh IPOM and Parietene Composite
meshes scored equally well and were superior to
Proceed. Findings are summarised in ⊡ Table 50.1.

Discussion

Numerous publications, including those of an ex-


perimental nature, concentrate mainly on the ex-
tent and pathology of adhesions. In this regard,
polypropylene meshes have proven to be consid-
erably inferior to ePTFE meshes. In our study
we were able to show that the lightweight and
b
large-pore TiMesh Light is associated with fewer
adhesions than ePTFE mesh, and in no cases were
intestinal adhesions seen. This confirms that the
structure of the material employed is of decisive
importance for this phenomenon. The reduction
in material and increase in pore size represent
a considerable improvement over the original
heavier polypropylene mesh [1, 3, 5–7].
The adhesions of the intestine to the mesh de-
scribed in other publications [8–10] were not seen
in our experiments. A major factor here is certainly
c
the minimally invasive placement of the mesh and
⊡ Fig. 50.8a–c. Results of second experiment. The polypro-
the lack of previous adhesiolysis or injury of the
pylene meshes were all well integrated into the surrounding peritoneum. Adhesion reactions include that of
tissue. Formation of the neoperitoneum was complete in the the tissue to foreign material, which, in the case
adhesion-free areas of intraperitoneal meshplasty, takes place at the
peritoneum–mesh interface.
As also borne out by our series of experiments,
The partial volume of inflammatory cells the collagen-coated mesh has performed very well
showed the lowest values for Parietene Composite. in all tests. In most cases, Parietex Composite
With a value of 6.6±2.9%, this was significantly mesh (with polyester) was used [4, 11–14], and in
lower than for Proceed, at 14.7±4.6% (p=0.006), some cases Parietene Composite mesh (with poly-
or for DynaMesh IPOM, at 19.7±7.8% (p=0.007). propylene) was used [14–17].
The Ki67-positive cells in a proliferation stage were Proceed showed a higher rate of adhesions.
also significantly lower for Parietene Composite, at However, the cellulose-based coating, albeit in
388 Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?

⊡ Table 50.1

Dynamesh IPOM Proceed Parietene Composite

Shrinkage rate (%) 14.2±7.1 25.0±7.5 14.0±8.6


(p=0.029 vs. Proceed) (p=0.041 vs. Proceed)

Adhesion rate of the greater 33.2±11.9 31.7±18.6 12.8±9.9


omentum (%) (p=0.01 vs. Dynamesh)

Partial volume of inflammatory 19.7±7.8 14.7±4.6 6.5±2.9


cells (%) (p=0.007 vs. Dynamesh)
(p=0.006 vs. Proceed)

Proliferation Ki67 (%) 7.2±6.7 10.8±5.7 4.5±2.7


(p=0.04 vs. Proceed)

Apoptotic index (%) 1.2±0.4 1.5±0.8 1.7±0.8

Macrophages/monocytes activity 12.5±2.2 5.5±2.9 3.8±2.2


(CD 68) (p=0.001 vs. Dynamesh) (p<0.001 vs. Dynamesh)

Extracellular matrix 55.8±35.2 37.4±22.4 20.8±8.8


TGF-ß

30

50 25

20

15 PV (%)
Ki67 (%)
AI (%)
10

⊡ Fig. 50.9. Histopathologic


results of second experiment 0
(PV partial volume of inflamm- DualMesh TiMesh light Parietene DynaMesh Proceed
atory cells; AI apoptotic index) Composite

combination with hyaluronic acid (Sepramesh), differences are reflected at a cellular level only
appears to confer advantages in principle, as at- in terms of the partial volume of the inflamma-
tested to by some experimental studies [14, 16, tory cells. Apart from that, no significant differ-
18–23]. It is possible that the combination with ences were seen between Proceed and Parietene
the slowly absorbable PDS (polydioxanone) plays Composite regarding the chronic inflammatory
a role because degradation of the material over reaction.
a 3–4-month period provokes an acute inflam- The adhesion rate of DynaMesh IPOM was
matory reaction. However, by that stage, these on a par with that of Proceed. The widespread
Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?
389 50
chronic inflammation no doubt played a role here. maining inflammatory parameters, including the
To what extent this is also determined by the adhesion rate, were markedly higher than those of
surface structure (i.e. porous structure) or the Proceed or Parietene Composite. Presumably this
amount of material used is something that can be is attributable to the mesh’s very good elasticity,
conjectured only from other experimental find- which counteracts a shrinkage reaction.
ings [24, 25]. As expected, mesh integration into the abdom-
Greater attention needs to be paid to the ef- inal wall was assured thanks to the textile structure
fect of shrinkage. The pathophysiological reac- of the polypropylene material used in all meshes,
tions involved in this phenomenon are extremely in the absence of any major chronic inflammatory
complex, with shrinkage of the material being reaction. Through-growth of the individual poly-
the last link in the body’s chain of reactions to propylene fibres confers a high degree of fixation
the foreign material. This reaction appears to be strength, which is preserved even after reduction
clearly related to the site of mesh placement and of the polypropylene material.
also to the amount and structure of the material
[2, 26–28]. This would also explain the observa-
tion that, over the long term, polypropylene mesh, Conclusions
fixed in an identical manner, shows considerably
less tendency to shrink than does ePTFE. These On the basis of our results, we must conclude
reactions appear to persist over a period of years, that the titanium-coated polypropylene mesh is
as Klinge et al. were able to show in explanted suitable for laparoscopic intraperitoneal repair of
meshes [2, 27]. abdominal wall and incisional hernias and that it is
Because PTFE is not really a mesh, but rather comparable to DualMesh with regard to adhesions
a membrane, it cannot be completely integrated but is clearly superior in terms of shrinkage. So
despite the texturing of the surface in contact over the long term, it is likely to be associated with
with the abdominal wall. The presence of pores a reduction in recurrence rates.
in the mesh makes it possible for the individual The collagen coating of the polypropylene
mesh fibres to become incorporated within the mesh appears to confer important advantages in
process of neoperitoneum formation. In contrast, terms of biocompatibility, with implications for
a capsule formed around the foreign material is the adhesion and shrinkage profiles of the mesh
consolidated by the chronic inflammatory reac- material.
tion that occurs. The cellular reaction induced No doubt, improvements can still be made re-
by the material is considerably greater in the garding handling, composition of the coating, and
case of implanted membranes in comparison with tendency towards infection. Further research and
lightweight structured meshes, as we were able experimental investigations, as well as prospective
to demonstrate by examining the partial volume randomised clinical trials, are thus needed.
of the inflammatory cells. Increased inflamma-
tory activity is accompanied by an increase in cell
proliferation. During the course of this process, References
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in an increase in the apoptosis index. All three
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9. Bellon JM, Contreras LA, Pascual G, Bujan J. Neoperitoneal repair. Surg Endosc 2006; 20:1320–1325
formation after implantation of various biomaterials for 22. Dilege E, Coskun H, Gunduz B, Sakiz D, Mihmanli M.
the repair of abdominal wall defects in rabbits. Eur J Surg Prevention of adhesion to prosthetic mesh in incisional
1999; 165:145–150 ventral hernias: comparison of different barriers in an
10. Matthews BD, Pratt BL, Pollinger HS, Backus CL, Kercher experimental model. Eur Surg Res 2006; 38:358–364
KW, Sing RF, Heniford BT. Assessment of adhesion forma- 23. Felemovicius I, Bonsack ME, Hagerman G, Delaney JP. Pre-
tion to intra-abdominal polypropylene mesh and polytet- vention of adhesions to polypropylene mesh. J Am Coll
rafluoroethylene mesh. J Surg Res 2003; 114:126–132 Surg 2004; 198:543–548
11. Bellon JM, Garcia-Carranza A, Jurado F, Garcia-Honduvilla 24. Kayaoglu HA, Ozkan N, Hazinedaroglu SM, Ersoy OF, Erkek
N, Carrera-San Martin A, Bujan J. Peritoneal regeneration AB, Koseoglu RD. Comparison of adhesive properties of
after implant of composite prosthesis in the abdominal five different prosthetic materials used in hernioplasty. J
wall. World J Surg 2001; 25:147–152 Invest Surg 2005; 18:89–95
12. Bellon JM, Garcia-Honduvilla N, Jurado F ,Garcia-Carranza 25. Bellon JM, Rodriguez M, Garcia-Honduvilla N, Pascual G,
A, Garcia-Moreno F, Martin AC, Bujan J. Use of composite Bujan J. Partially absorbable meshes for hernia repair offer
prostheses in the repair of defects in abdominal wall: advantages over nonabsorbable meshes. Am J Surg 2007;
prosthetic behaviour at the peritoneum. Eur J Surg 2001; 194:68–74
167:666–671 26. Weyhe D, Belyaev O, Müller C, Meurer K, Bauer KH, Papa-
13. Bellon JM, Jurado F, Garcia-Honduvilla N, Lopez R, Car- postou G, Uhl W. Improving outcomes in hernia repair
rera-San Martin A, Bujan J. The structure of a biomaterial by the use of light meshes–a comparison of different
rather than its chemical composition modulates the implant constructions based on a critical appraisal of the
repair process at the peritoneal level. Am J Surg 2002; literature. Word J Surg 2007; 31:234–244
184:154–159 27. Klinge U, Klosterhalfen B, Müller M, Ottinger AP, Schum-
14. Gonzalez R, Rodeheaver GT, Moody DL, Foresman PA, pelick V (1998) Shrinking of polypropylene mesh in vivo:
Ramshaw BJ. Resistance to adhesion formation: a com- an experimental study in dogs. Eur J Surg 1998; 164:965–
parative study of treated and untreated mesh products 959
placed in abdominal cavity. Hernia 2004; 8:213–219 28. Klinge U, Klosterhalfen B, Müller M, Schumpelick V. For-
15. McGinty JJ, Hogle NJ, McCarthy H, Fowler DL. A compa- eign body reaction to meshes used for the repair of abdo-
rative study of adhesion formation and abdominal wall minal wall hernias. Eur J Surg 1999; 165:665–673
ingrowth after laparoscopic ventral hernia repair in a
Chapter 50 · Benefit of Lightweight and/or Titanium Meshes?
391 50
Discussion

Amid: Adhesion formation is not as important as


what the intestine adheres to. Formation of intes-
tinal fistula is something very slow; the longest
reported period was 15 years. Now the decision
of which meshes to use depends on the adhesive
property. But what matters is what the bowel ad-
heres to.
Schug-Paß: In our experiment, we did not violate
the peritoneum. There were only adhesions to the
omentum and not to the intestine. We think that if
there is a neoperitoneum formation that covers the
meshes, there is no problem.
Kukleta: The mesh that you chose as the best one
was the first mesh that I used. But I left it because
of the number of adhesions in patients that I had
to reoperate. And if it is even covered with neo-
peritoneum, you cannot prevent adhesions with it.
Deysine: Is this a thin film of titanium on the
mesh?
Schug-Paß: It is a special technique invented by
GFE. The coating of the lightweight meshes makes
no difference, but it might be different with heavy
meshes. One advantage is that the titanium coat-
ing makes the polypropylene hydrophilic and thus
easier to handle.
Desine: I thought polypropylene was hydrophilic
on its own.
Schug-Paß: No.
51

ePTFE Prostheses and Modifications


G. Pascual, J. M. Bellón
394 Chapter 51 · ePTFE Prostheses and Modifications

Introduction the advantageous behavior of ePTFE had already


been described. These authors [16] reported that
Expanded polytetrafluoroethylene (ePTFE) is a in 28 operated patients, this material induced a
microporous, laminar, hydrophobic prosthetic ma- good tissue response as well as a minimal inflam-
terial with a negative charge. It is composed of matory response and infiltration of fibroblasts and
compact nodules interlinked by fine fibers. The collagen in the interstices of the prosthesis. At
length of these fibers determines the material’s 10.7%, their hernia recurrence rate was compara-
internodal distance and pore size. ble to those quoted later by other authors [19–22].
The first report of the use of polytetrafluoro- In a clinical study of patients with incisional
ethylene for the repair of abdominal wall defects hernias, Van der Lei et al. [23] described the need
was that by Harrison in 1957 [1], whose results for prosthetic overlap of the tissue defect and a
were certainly promising. However, the perfor- double suture to fix the prosthesis to avoid rehernia-
mance of this material in woven form as a prosthe- tion. In addition, as had been described by others in
sis was so disappointing [2] that its clinical use was experimental studies, the favorable behavior of STP
soon abandoned. at the peritoneal level was indicated. In subsequent
A few years later, in 1963, Oshige [3] described clinical trials [24, 25], this property of ePTFE was
a method of expanding polytetrafluoroethylene, confirmed and was soon to prompt the use of STP
preserving its microstructure and increasing its in the laparoscopic approach to hernia repair.
mechanical resistance. This process was refined A property of the ePTFE patch that we should
by Gore [4] and applied in the manufacturing of discuss is its behavior in the presence of infec-
vascular prostheses for clinical use. This was fol- tion. The studies by Law and Ellis [26] demon-
lowed by further significant expansion to provide strated that other materials, such as polypropylene,
a layered material that could be used to repair her- showed better tolerance to infection than ePTFE
nias and other soft tissue defects. The first of these did. These findings were corroborated by other
prostheses used to repair parietal defects in the authors [27–30]. In clinical practice, it is generally
51 abdomen was the Soft Tissue Patch (STP). accepted that ePTFE is more prone to infection
The behavior of ePTFE in the repair of abdom- than other biomaterials and that when infection
inal wall defects was initially studied in the labo- occurs, most ePTFE implants will need to be re-
ratory. The works of Elliot and Juler in 1979 [5] moved [31, 32].
revealed the good biological tolerance of this mate-
rial, and Sher et al. [6], in 1980, were the first to
describe its superior peritoneal behavior compared Structural Changes Suffered by ePTFE
with polypropylene. This finding was highlighted Prostheses
by Lamb et al. [7], who observed that the inflam-
matory response to an ePTFE implant was mini- The lack of good tissue incorporation [33] and
mal. Subsequent experimental studies [8–11] con- a sometimes considerable hernia recurrence rate
firmed the favorable behavior of the ePTFE patch induced the first modifications to this prosthetic
at the peritoneal interface. Taking advantage of this material. The first of these was the introduction
particular behavior, Walker et al. [12] were the first of multiple perforations in the ePTFE patch in an
to elaborate a composite prosthesis in which poly- effort to achieve a prosthesis that, although still
propylene was combined with a layer of ePTFE on laminar in structure, would have the properties of
the peritoneum-facing side of the implant. Using a reticular mesh. The initial idea of converting the
similar composites, good results were reported in STP into a macroporous prosthesis belonged to
experimental studies conducted by other authors Simmermacher et al. [11], who made multiple per-
[13, 14] and even in clinical practice [15]. forations in an ePTFE prosthesis to improve tissue
The work of Bauer et al. [16] introduced the ingrowth. These authors even tried to modify the
use of ePTFE in clinical hernia repair in the form prosthetic structure by pretreating the ePTFE with
of the STP, although in earlier publications [17, 18] ethanol to increase its porosity. They observed no
Chapter 51 · ePTFE Prostheses and Modifications
395 51
gain in mechanical strength attributable to such esh Plus. The antimicrobial agents used for pre-
modifications. Despite this, these experiments led treatment were silver carbonate and chlorhexidine
to the first modification of ePTFE in the form of a diacetate. Harrell et al. [36] recently demonstrated
prosthesis called MycroMesh (MM). the in vitro efficiency of these pretreatments.
In an experimental study in our laboratory
[34], we observed no biomechanical benefits of the
new MM over conventional ePTFE in the form of Personal Experience with Experimental
a patch (STP). Further, because of its lack of sur- and Clinical ePTFE Implants
face smoothness due to the presence of multiple
orifices, greater adhesion formation was induced Our experimental and clinical findings using a
when it was implanted over the peritoneum. New Zealand White rabbit implant model have
A further modification to the ePTFE patch been as follows.
was the creation of a prosthesis with some sort of Macroscopic observations at the tissue–tissue
barrier on its peritoneal side to prevent cell infil- interface reveal that ePTFE becomes encapsulated
tration. This prosthesis was given the commercial such that the mesh is enveloped by an organized
name of DualMesh (DM). connective tissue to form a »sandwich.« When
Further studies by our group [35] indicated the the implant makes contact with the visceral peri-
practically identical behavior of this new prosthe- toneum, correct mesothelialization occurs from
sis to that of the classic ePTFE patches. Although the first moments of implantation. Despite the
there was no cell ingrowth on one of its sides, this different modifications to the layer of ePTFE, its
did not seem to affect its behavior at the peritoneal macroscopic behavior fails to vary.
interface, and its mesothelialization and neoperi- On microscopic observation, tissue incorpora-
toneum formation were similar to observations tion is preferentially cellular. STP and DM show
of STP. Furthermore, no changes were noted in similar behavior in that host cells are able to pen-
mechanical strength after implantation. etrate as far as one-third of the mesh thickness.
A final modification to DM took the form of In STP, this occurs on both surfaces; in DM, only
the Corduroy type, for which a rough surface was one surface is affected. Neoperitoneum formation
created on its non-peritoneal-facing side. The ob- is similar for both prostheses, and observations
jective was to improve tissue incorporation. How- include the presence of mesothelial cells and a
ever, studies by our group (unpublished results) well-organized peritoneum.
indicated that tissue infiltration with the Corduroy Using the MM variant, tissue ingrowth pro-
mesh was similar to that for the other ePTFE ceeds via the orifices created in the prosthesis such
prostheses, with no improvement in mechanical that tissue bridges may be observed between the
resistance compared with previous designs. two prosthetic surfaces, with the existence of cel-
lular integration as well. Unlike STP and DM, the
MM mesh induces angiogenesis in the perforation
Modifications Involving Pretreatments zones.
For the rough-surface variant of DM, incorpo-
Infection of a prosthetic material continues to be ration continues to be cellular, with tissue depos-
a significant problem in clinical practice. Given ited between the rough zones of the ePTFE surface
the generally poor tolerance of ePTFE to infection, (⊡ Fig. 51.1).
determined by its microstructure, one of the in- On the peritoneal-facing side, adhesion forma-
novations applied to ePTFE prostheses was their tion is almost null, and when it occurs, as some-
pretreatment with substances that would inhibit times observed with MM, these adhesions are very
bacterial colonization during the initial moments loose (⊡ Fig. 51.2).
of implantation and thus prevent biofilm forma- An important feature to consider is the foreign
tion. This gave rise to modified prostheses with body reaction induced by the biomaterial. With
bactericidal activity: MycroMesh Plus and DualM- the use of a monoclonal antibody specific for rab-
396 Chapter 51 · ePTFE Prostheses and Modifications

51

⊡ Fig. 51.1. Macroscopic appearance of the different prostheses tested (left). Diagrams (middle) and microscopic examinations
(right) of the implants showing tissue incorporation of the biomaterials 30 days after implantation. Both surfaces of the Soft Tis-
sue Patch (STP) implant have become encapsulated by host connective tissue. Cell colonization is detectable on both prosthetic
surfaces. Scar tissue surrounds the MycroMesh (MM) implant on both the peritoneal-facing and subcutaneous-tissue-facing
sides. The arrows indicate the neoformed tissue within the prosthetic MM perforations. In both MM and STP, cells penetrate
beyond one-third of the mesh thickness. Microscopic observation of the DualMesh (DM) and DM Corduroy implants indicates
no major differences with respect to the other implants; the only differences noted are the lack of fibrous colonization of the
nonporous DM surface (PS peritoneal side; SS subcutaneous side)

bit, macrophage counts were always the same for As already demonstrated by Amid et al. [13]
all of the prostheses. These counts were higher at using other materials, when the spatial structure
the early implantation stage and thereafter under- of a prosthesis changes, its tissue behavior varies
went a steady decrease (⊡ Fig. 51.3). despite its unchanged composition. In a prosthetic
The mechanical strength of the different pros- design in which we used ePTFE suture thread
theses (STP, MM, DM, and DM Corduroy) failed (Cv4) to construct a mesh [37], the mesh’s behav-
to differ significantly (⊡ Fig. 51.4). Thus, questions ior was similar to that of a reticular-type mesh.
arise regarding whether this similar tissue in- Moreover, its mechanical behavior postimplanta-
growth induced by the ePTFE and all its modified tion varied appreciably to attain tensile strength
forms depends on the chemical composition, and values comparable to those of a polypropylene
whether it can be modulated. prosthesis. This design revealed the different tissue
Chapter 51 · ePTFE Prostheses and Modifications
397 51

⊡ Fig. 51.2. Macroscopic images of adhesion formation to the different prostheses. The percentage of adhesion formation is
greater for the MycroMesh (MM) prosthesis than for the other three (Soft Tissue Patch, DualMesh, and DualMesh Corduroy) pros-
theses. Adhesions appear in areas corresponding to the suture and perforations of the MM implant. Most of these adhesions are
very loose in consistency

50
Macrophage number

40

30

20

10

0
14 days 30 days 60 days 90 days

Soft Tissue Patch MycroMesh


DualMesh DualMesh Corduroy

⊡ Fig. 51.3. Number of macrophage cells recorded for the


different expanded polytetrafluoroethylene prostheses im-
planted in the abdominal wall of New Zealand White rabbits
for 14–90 days

incorporation of laminar relative to reticular-type ⊡ Fig. 51.4. Postimplantation tensile strengths of the different
prostheses. Resistance to traction increased steadily, reaching
materials.
significance with respect to initial values 30–90 days after im-
Another problem mentioned earlier is the issue plantation of the different prostheses. These values are similar
of prosthetic infection. In a model of experimental for the different types of expanded polytetrafluoroethylene
infection, we were able to observe ultrastructural prostheses at the same study times
398 Chapter 51 · ePTFE Prostheses and Modifications

changes in ePTFE induced by bacterial contamina- 8. Murphy JL, Freeman JB, Dionne PG. Comparison of Mar-
tion. The microbes penetrated the interstitial zones lex and Gore-Tex to repair abdominal wall defects in the
rat. Can J Surg 1989; 32:244–247
of the prostheses, where they settled. We observed
9. Pans A, Pierard GE. A comparison of intraperitoneal pros-
changes in internode fibers and in zones of an- theses for the repair of abdominal muscular wall defects
chorage to host tissue. in rats. Eur Surg Res 1992; 24:54–60
In clinical practice (1997), the behavior of the 10. Le Blanc KA. Two-phase in vivo comparison study of ad-
ePTFE implants proved to be similar to that shown hesion formation of the Gore-Tex soft tissue patch, Mar-
lex mesh and Surgipro using a rabbit model. In: Arregui
experimentally. The same occurred in cases of pros-
ME, Nagan RF. Inguinal hernia, advances and controver-
thetic infection. In most cases of infection, the pros- sies. Radcliffe Medical Press, Oxford, 1994, pp 501–504
thesis must be replaced. We have no experience with 11. Simmermacher RKJ, Van der Lei B, Schakenraad JM, Ble-
the use of pretreated ePTFE (MM Plus/DM Plus), ichrodt RP. Improved tissue ingrowth and anchorage of
although the in vitro studies described above have expanded polytetrafluoroethylene by perforation: an ex-
yielded promising results in settings of infection. perimental study in the rat. Biomaterials 1991; 12:22–24
12. Walker AP, Henderson J, Condon RE. Double-layer pros-
theses for repair of abdominal wall defects in a rabbit
model. J Surg Res 1993; 55:32–37
Conclusions 13. Amid PK, Shulman AG, Lichtenstein IL, Sostrin S, Young J,
Hakakha M. Experimental evaluation of a new composite
1. No modifications made to the earliest laminar mesh with the selective property of incorporation to
the abdominal wall without adhering the intestines. J
ePTFE prosthesis, or Soft Tissue Patch, have
Biomed Mat Res 1994; 28:373–375
resulted in any changes or improvement in tis- 14. Bellón JM, Buján J, Contreras L, Jurado F. Use of non-po-
sue incorporation or postimplantation biome- rous polytetrafluoroethylene prostheses in combination
chanical strength. with polypropylene prosthetic abdominal wall implants
2. Only changes in the spatial architecture of a in prevention of peritoneal adhesions. J Biomed Mat Res
1997; 38:197–202
biomaterial will alter the pattern of tissue in-
15. Bendavid R. Composite mesh (polypropylene–ePTFE) in
corporation and biomechanical strength. the intraperitoneal position: a report of 30 cases. Hernia
51 3. When confronted with infection, ePTFE and 1997; 1:5–8
its variants respond in the same susceptible 16. Bauer JJ, Salky BA, Gelernt LM, Kreel I. Repair of large
way, with the exception of the pretreated pros- abdominal wall defects with expanded polytetrafluoro-
ethylene (PTFE). Ann Surg 1987; 206:765–769
theses.
17. Hamer-Hodges DW, Scott NB. Replacement of an abdom-
inal wall defect using expanded PTFE sheet (Gore-Tex). J R
Coll Surg Edinb 1985; 30:65–67
References 18. Wool NL, Straus AK, Roseman DL. Clinical experience with
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Surg Gynecol Obstet 1957; 104:584–590 19. Pailler JL, Manaa J, Vicq PH, Brissiaud JC, Gandon F. Cure
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30:481–486 20. Pailler JL, Essoussi H, De Calan L. Eventration post-opera-
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1967 21. Kluger Y, Katz E, Ayalon A, Durst A. Repair of large abdom-
4. Gore RW. Process for producing porous products. U.S. inal wall defects with expanded polytetrafluoroethylene.
patent 3953566, WL Gore and Associates, 27 April 1976 Harefuah 1989; 117:292–295
5. Elliot M, Juler GL. Comparison of Marlex mesh and mi- 22. Law NW, Ellis H. Preliminary results for the repair of dif-
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the experimental animal. Am J Surg 1979; 137:342–345 patch. Acta Chir Scand 1990; 156:609–612
6. Sher W, Pollack D, Paulides CA, Matsumoto T. Repair of ab- 23. Van der Lei B, Bleichrodt RP, Simmermacher RKJ, Schif-
dominal wall defects: Gore-Tex vs Marlex graft. Am Surg gaarde R. Expanded polytetrafluoroethylene patch for
1980; 110:618–623 the repair of large abdominal wall defects. Br J Surg 1989;
7. Lamb JP, Vitale T, Kaminsky DL. Comparative evaluation of 76:803–805
synthetic meshes used for abdominal wall replacement. 24. Bellón JM, Contreras LA, Sabater C, Buján J. Pathologic
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25. Utrera-González A, De la Portilla F, Carranza-Albarrán G.
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27. Bleichrodt RP, Simmermacher RJK, Van der Lei B, Shak-
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33. Simmernmacher RKJ, Shakenraad JM, Bleichrodt RP. Re-
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184:154–159
52

The Role of Stem Cells in Abdominal


Wall Repair
M. G. Franz
402 Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair

Introduction and growth factors in culture and are reported to


be nonimmunogenic [14–17]. Stem cell therapy
Incisional hernias fundamentally result from acute of abdominal wall wounds may therefore acceler-
laparotomy wound failure. Evidence supports the ate and improve the gain in laparotomy breaking
mechanism that gaps in the early laparotomy re- strength and, in so doing, decrease the incidence
pair progress to clinical incisional hernias [1, 2]. and severity of surgical wound failure and inci-
The linea alba is especially at risk for acute wound sional hernia formation.
failure because of the low number of repair fi-
broblasts and relative ischemia at this location of
the abdominal wall. Laparotomy wound-healing Materials and Methods
failure occurs when there is (1) reduced quantity
or 2) impaired quality of collagen matrix synthe- AMP and GFP-labeled AMP Cells
sis, recellularization, and, ultimately, tissue repair
[3]. Surgical and mechanical approaches to the Amnion-derived multipotent progenitor (AMP)
problem of incisional hernia formation and repair cells and AMP cells labeled with green fluorescent
may underestimate how the biological response to protein (AMP-GFP) were provided by Stemnion
injured tissue affects wound-healing outcomes. (Pittsburgh, PA, USA). Amnion cells were isolated
Surgical wound-healing failure is defined at the from placentas following cesarean section and were
tissue, cellular, and molecular levels. A major nor- processed by proprietary techniques.
mal mechanism is fibroblast activation from quies-
cence and progression of the repair cell cycle after
injury [3]. It is unknown whether wound failure of Animal Model
the abdominal wall results from a primary inher-
ited defect in fascial fibroblast activation leading The rat models of laparotomy healing and in-
to incisional hernia formation or, conversely, from cisional hernias have been previously described
an abnormal wound milieu after mechanical fas- [18–20]. Sprague–Dawley rats weighing 450 g were
cial wound failure that induces impaired fibroblast acclimated and housed under standard conditions.
52 function [3]. A combination of the two may exist. All animal care and operative procedures were
One strategy to improve acute wound healing performed in accordance with the United States
and decrease surgical wound failure is the phar- Public Health Service Guide for the Care of Labo-
macological use of cytokine growth factors, which ratory Animals and were approved by the Univer-
increase skin incision strength and decrease the sity of Michigan Committee on the Use and Care
incidence of incisional hernias in experimental of Animals.
models [4–7]. In vivo growth factor therapy, how-
ever, is limited by short half-lives. Another strategy
is cell-based therapy. Stem cells and stem-cell-like Laparotomy Wound-Healing Model
multipotent cells express the ability to differenti-
ate into different cell types that are important Briefly, a ventral skin flap was raised through the
for wound healing and tissue repair [8–10]. Stem avascular prefascial plane, and a 5-cm laparotomy
cells also secrete growth factors that signal paral- incision was made through the linea alba. The lap-
lel cellular processes active during wound healing. arotomy was repaired with a running 4-0 polypro-
The sensor capability of cell sources of tissue re- pylene suture. The skin flap was securely sutured.
pair signals may result in more physiologic heal- Two groups were studied: (1) abdominal walls
ing through signal combination and dose [9–11]. treated with normal saline (NS) as the control
Amnion-derived cells express characteristics of (NS-S control) and (2) abdominal walls treated
stem cells, including the ability to differentiate with NS-washed, human-amnion-derived multi-
into distinct cell types of varied tissue lineages [12, potent progenitor cells (AMP-S group). In the
13]. Amnion-derived cells also secrete cytokines NS-S group, the midline of the abdominal wall
Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair
403 52
(linea alba) was injected over 5 cm with 200 μl of specimen per unit area, calculated as Fmax/cross-
NS. In the AMP-S group, 200 μl of NS containing sectional area (N/mm2); energy at break (mJ);
106 amnion epithelial cells was similarly injected. yield strength (N); yield energy (mJ); and stiffness,
Surgical-site priming was performed with a 22-g the slope of the linear elastic region of the force-
hypodermic needle (0.7×38 mm) into the linea extension curve (N/mm), were generated.
alba. Soft tissue distribution of NS or AMP cell
suspension was achieved. After 5 min, the laparo-
tomy incision was made and repaired as described Incisional Hernia Model
above.
On postoperative days (PODs) 7, 14, and 28, Incisional hernia models were used as previously
the rats were killed. Isolated abdominal wall mus- described [18, 20]. Again, a skin flap was raised,
cle and tendon strips and fresh biopsies of the and a 5-cm laparotomy incision was made through
abdominal wall to the laparotomy wound-healing the linea alba. To induce hernia formation, two
interface were collected for mechanical and histo- fast-absorbing 5-0 plain gut stitches were placed at
logical testing. the cranial extent and midpoint of the laparotomy
incision. The skin flap was again secured. Groups
Laparotomy Wound Breaking Strength treated with NS (NS-H control) and human-amni-
and Mechanical Properties on-derived multipotent progenitor cells (AMP-H)
Mechanical testing was done on abdominal wall were again used for this experiment. In the NS-H
strips collected from the laparotomy wound- control group, 200 μl of NS was injected along the
healing model as previously reported [4, 19, 20]. midline for 5 cm. In the AMP-H group, 200 μl of
Briefly, sutures were removed. Abdominal wall NS containing 1.5×106 amnion epithelial cells was
strips were made perpendicular to the wound- injected along the linea alba for 5 cm. On POD 28,
healing interface. A cutting template was used to the rats were killed, and the musculotendinous
mark the abdominal wall to minimize the size layer of the abdominal wall was collected and ex-
variability among specimens. Strips were cut amined for incisional hernias.
10 mm in width and 60–80 mm in length. Two
strips were collected from each rat, and testing was Measurement of Hernia Size
performed within 6 h of necropsy. The thickness of For hernia size measurement, hernia model rats
the fascial tissue strip at the wound and the length were killed on POD 28. The skin was dissected free
between grips were measured with Digimatic cali- circumferentially, and a 5×10-cm section of the
pers. Force extension curves were generated for abdominal wall muscle was excised. The muscle
each fascial strip with the use of an Instron tensi- was stretched out and pinned down on a dissect-
ometer equipped with a 50-N static load cell set at ing board at the four corners with the peritoneal
a crosshead speed of 10 mm/min. The fascial strips side up. A standardized digital picture was taken.
were mounted into the load frame with the use of Software Spot version 4.5 for Windows was used
pneumatic grips, preloaded to 0.1 N with a gauge to calculate hernia size on digital pictures. Calibra-
length between the grips of around 10 mm. The tion was set up using the rule reference on each
load frame applied testing loads to the fascial strips picture. A circle was drawn along the hernia ring
until mechanical tissue disruption occurred. Force to measure the hernia size in square centimeters.
and tissue deformation data were simultaneously
recorded and captured on a computer connected
to the load frame via a digital interface card. Data Laparotomy and Incisional Hernia
analysis was performed with the use of the Merlin Histology
materials testing software package (Instron, Can-
ton, MA, USA). Breaking strength, the maximum Laparotomy wound or hernia sections were cut
load force (Fmax) at mechanical failure (N); tensile and fixed in formalin for histology. Specimens were
strength, the maximum stress developed in the stained with hematoxylin and eosin or trichrome.
404 Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair

Viable AMP-GFP cells were also injected into the Results


linea alba as described above. These tissues were
embedded in O.C.T. compound and snap-frozen Viability of AMP in Laparotomy
immediately in liquid nitrogen. A piece of sagittal Wounds and Hernias
fascial wound from the linea alba was fixed in 10%
formalin on ice for 6 h, dehydrated through graded Successful transplantation requires clinical viabil-
sucrose washes for 24 h, and finally embedded in ity of the transplanted AMP. To test the survival
O.C.T. compound and snapped in liquid nitrogen. of AMP cells in our models, 2.5×106 AMP-GFP
Serial cryostat sections were made for fluorescence cells were injected into the linea alba, and laparo-
microscopy to evaluate the distribution or localiza- tomies were performed. Rats were killed on PODs
tion of GFP-positive cells. 7, 14, and 28, and laparotomy tissue was collected.
Frozen-tissue sections were prepared for fluores-
cence microscopy. AMP cells expressed GFP in
Statistics laparotomy wound sections on PODs 7, 14, and
28, confirming AMP cell viability over this time
Statistical analysis was performed using GraphPad course (⊡ Fig. 52.1).
Prism version 4.0 for Windows. A t-test was used
to compare the difference between the NS control
group and AMP-treated groups. This software was AMP Cells Accelerate Laparotomy
also used to create the incidence curves of inci- Healing
sional hernia at POD 28 for fractional hernia of
any particular hernia or wound defect size and to Tensiometric measurements found significant dif-
compare the curves between the NS-H control and ferences in mechanical properties of the NS-S and
AMP-H groups. The significance level was set at AMP-S groups following laparotomy. All wounds
P<0.05. were disrupted at the fascia–fascia interface of

52

⊡ Fig. 52.1. Viability of human-


amnion-derived multipotent pro-
genitor cells labeled with green
fluorescent protein (AMP-GFP) in a b
laparotomy wounds. AMP-GFP
were injected in the rat linea
alba, and tissue was harvested at
postoperative days (PODs) 7, 14,
and 28. Frozen-tissue sections
of abdominal wall collected at
these three time points were
examined under a fluorescent
microscope. a POD 7. b POD 14.
c POD 28. d Frozen skin tissue
section adjacent to injection site
c d
collected on POD 7
Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair
405 52
the laparotomy wound. Wounds treated with 106 be summarized as follows: (1) A primary defect
AMP cells developed increased breaking strength or delay in repair cell activation and provisional
by POD 7 (⊡ Fig. 52.2). Laparotomy scar tissue wound matrix crystallization during acute fascial
sampled on POD 7 showed greater vascularization repair causes herniation, or (2) mechanical failure
and fibrosis in the AMP-S group compared with and dehiscence cause a delay or deficiency in the
the NS-S group (⊡ Fig. 52.2g, h). Wound strength acute wound-healing process [3]. The first is an in-
properties continued to increase until POD 28. herited biological mechanism, and the second is an
Differences in the recovery of wound-breaking acquired biomechanical or biosurgical mechanism.
properties were less on PODs 14 and 28, which is It is possible that both mechanisms are active in
consistent with normal acute wound healing in the a reinforcing cycle of surgical wound failure and
NS control group. herniation.
Wound breaking strength is the mechanical
property of a laparotomy that determines its abil-
AMP Cells Reduce Laparotomy ity to resist distractive forces. Burst abdomens, or
Dehiscence and Herniation acute fascial dehiscence with evisceration, are one
important extreme of laparotomy failure.
To test whether accelerated laparotomy repair us- Studies report that amniotic cell therapy im-
ing AMP cells prevented hernia formation, AMP proves spinal injury and does not induce an im-
cells or NS was delivered to the linea alba in the mune rejection reaction [17, 21–23]. Human am-
hernia model. The hernia or wound defect size in niotic epithelial cells are not reported to express
the AMP-H group was significantly smaller than in surface HLA-A, -B, -C, or -DR antigens or beta
the NS-H group (0.82±0.16 cm2 vs 2.72±0.56 cm2; 2-microglobulin [21]. Human amnion epithelial
⊡ Fig. 52.3). Histology of the healing laparotomy cells are also reported to survive up to 7 weeks
(⊡ Fig. 52.3b) or hernia ring (⊡ Fig. 52.3c) showed in vivo after allogeneic transplantation without in-
again that there was more vascularization and fi- ducing acute immune rejection. Other researchers
brosis in the AMP-H rats, suggesting accelerated found no residual amniotic epithelium in humans
and improved laparotomy wound repair in the 2–3 months after human amniotic cell implanta-
AMP-H group. In the best clinical study of predict- tion [24]. These findings support its therapeutic
ing incisional hernias, it was found that a 12-mm safety.
gap in the laparotomy closure on POD 30 results in There are several potential mechanisms by
incisional hernia 94% of the time. Conversely, only which AMP cells improve healing of laparotomy
3% of defects less than 12 mm in size developed in- incisions. AMP cells may differentiate into mes-
cisional hernias over 3 years [1]. Small laparotomy enchymal, fibroblast-like repair cells to replace
defects do not form incisional hernias, but bigger or augment fibroblasts in the failing laparotomy
ones do. The majority of AMP-treated animals wound. It is also possible that a repair or regenera-
developed very small laparotomy defects, if at all. tion signal secreted by AMP cells directs acceler-
The largest and smallest hernia or defect sizes were ated and/or normal fascial fibroblast repair [25].
1.88 cm2 and 0 cm2, respectively, in the AMP-H Our group has already reported the use of indi-
group vs. 6.28 cm2 and 0.50 cm2, respectively, in vidual growth factors–TGF-B2, bFGF, and GM-
the NS-H group. AMP treatment therefore reduces CSF–to accelerate laparotomy repair and prevent
the incidence of laparotomy wound failure that incisional hernia formation [5, 26, 27].
progresses to incisional hernia. Tissue growth factors are an important class
of tissue repair signaling peptides that are upregu-
lated during the lag phase of acute wound healing
Discussion [27]. However, 5–7 days are required before peak
levels of fibroproliferative growth factors such as
The two fundamental mechanisms for laparotomy TGF-β are reached in acute wounds [28]. Acute
wound failure leading to incisional hernia may wound therapy with proliferative growth factors is
406 Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair

A 12
NS AMP B 0.35
NS AMP
*
10 P=0.0109 * 0.30
P=0.0239

Tensile stress (N/mm2)


Maximum Load (N)

8 0.25

0.20
6
0.15
4
0.10
2
0.05
0 0.00
NS AMP NS AMP

45 D 3.5
C NS
** NS P=0.0559
40 3.0
AMP AMP
35
Energy at Break (mJ)

2.5

Stiffness (N/mm)
30 P=0.0027

25 2.0
20 1.5
15
1.0
10
0.5
5
0 0.0
NS AMP NS AMP

E 12
NS AMP
F 20
NS AMP
10 P=0.0276 P=0.0301 *
*
15
8
Yield Energy (mJ)
Yield Load (N)

6 10

4
5
52 2

0 0
NS AMP NS AMP

G H

⊡ Fig. 52.2. Tensiometric measurements and histology exam on postoperative day (POD) 7. Fascial mechanical breaking characteris-
tics were measured with an Instron tensiometer on POD 7 (a–f). Values are the mean ± SEM of six wound biopsies each from the nor-
mal saline (NS) control (NS-S) and the NS-washed human-amnion-derived multipotent progenitor cell (AMP-S) groups. A t-test was
used to compare the difference between the two groups [single asterisk (*): p<0.05; double asterisk (**): p<0.01]. Morphology of fascial
incisional wound at POD 7 from the NS-S (g) and AMP-S (h) groups. Hematoxylin and eosin staining was performed for histology
Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair
407 52
A 3.5 NS-H of incisional hernias arise from occult fascial de-
3.0 AMPs-H
hiscences, so a new emphasis is being placed on
improved laparotomy closure and healing, through
2.5 P=0.0042
either biological manipulation or the use of pro-
Hernia size (cm 2 )

2.0 phylactic soft tissue prostheses. Preclinical work


1.5
has confirmed that accelerated laparotomy repair
** through priming with tissue repair growth factors
1.0 can significantly reduce the incisional hernia rate
0.5 [4, 5]. The problems with single-peptide wound
therapy remain drug delivery, dosing, and timing.
0.0
NS-H AMPs-H Histological samples of AMP-treated wounds
are consistent with accelerated repair compared
B C with controls. There is more fibroplasia and angio-
genesis, and it is also suggested that the intensity
of the wound inflammatory response is modu-
lated and less severe. Collagen fibrils appear to
be more organized along natural lines of tension,
and the peritoneal lining appears restored during
AMP treatment. A comprehensive examination of
remote organs and tissue found no migration or
trafficking of AMP cells beyond the wound (data
not shown). This supports the application of AMP
cells in wound therapy. The immune privilege of
⊡ Fig. 52.3. Effect of human-amnion-derived multipotent
amnion-derived cells permits their use as an al-
progenitor (AMP) cells on hernia healing. Hernia or wound
defect size was measured on postoperative day 28. Values are lograft, and the containment of these cells to the
the mean ± SEM of 11 hernia biopsies each from the normal wound suggests their safety.
saline (NS) control (NS-H) and the AMP-hernia groups. [Dou-
ble asterisk (**): compared with NS-H, p<0.01]. Morphology
of hernia ring from the normal saline (NS) control (b) and NS- References
washed AMP (c) groups. Hematoxylin and eosin staining was
performed on tissue sections
1. Pollock AV, Evans M. Early prediction of late incisional
hernias. Br J Surg 1989;76:953–4
2. Burger JW, Lange JF, Halm JA, Kleinrensink GJ, Jeekel H.
Incisional hernia: early complication of abdominal sur-
known to accelerate the appearance of fibroblasts gery. World J Surg 2005;29(12):1608–13
and collagen into the wound, thereby shortening 3. Dubay DA, Franz MG. Acute wound healing: the biol-
ogy of acute wound failure. Surg Clin North Am
the natural lag phase for gain in injured tissue
2003;83(3):463–81
strength. The preponderance of clinical and pre- 4. Dubay DA, Wang X, Kuhn MA, Robson MC, Franz MG.
clinical evidence supports the concept that very The prevention of incisional hernia formation using a
early laparotomy wound failure is the mechanism delayed-release polymer of basic fibroblast growth factor.
of incisional hernia formation. Load-bearing lapa- Ann Surg 2004;240(1):179–86
5. Franz MG, Kuhn MA, Nguyen K et al. Transforming growth
rotomy wounds fail at the weakest point on the factor β2 lowers the incidence of incisional hernias. J Surg
acute wound-healing trajectory at the same time Res 2001;97(2):109–16
that surgical patients are recovering. Early wound 6. Robson MC, Dubay DA, Wang X, Franz MG. Effect of cy-
failure results in incisional hernia formation 94% tokine growth factors on the prevention of acute wound
failure. Wound Repair Regen 2004;12(1):38–43
of the time [1, 2]. Well-performed, prospective
7. Mustoe TA, Pierce GF, Thomason A, Gramates P, Sporn
series of incisional hernia repairs report early re- MB, Deuel TF. Accelerated healing of incisional wounds
currences, most within 3 years of operation. It is in rats induced by transforming growth factor-α. Science
therefore increasingly accepted that the majority 1987;237:1333–6
408 Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair

8. Yamaguchi Y, Kubo T, Murakami T et al. Bone marrow 24. Yeager AM, Singer HS, Buck JR et al. A therapeutic trial
cells differentiate into wound myofibroblasts and accel- of amniotic epithelial cell implantation in patients with
erate the healing of wounds with exposed bones when lysosomal storage diseases. Am J Med Genet 1985;
combined with an occlusive dressing. Br J Dermatol 22(2):347–55
2005;152(4):616–22 25. Steed DL, Trumpower C, Duffy D et al. Amnion-derived
9. Han SK, Yoon TH, Lee DG, Lee MA, Kim WK. Potential of cellular cytokine solution: a physiological combination of
human bone marrow stromal cells to accelerate wound cytokines for wound healing. Eplasty 2008;8:e18
healing in vitro. Ann Plast Surg 2005;55(4):414–9 26. Dubay DA, Wang X, Kirk S, Adamson BS, Robson MC,
10. Chunmeng S, Tianmin C, Yongping S et al. Effects of Franz MG. Fascial fibroblast kinetic activity is increased
dermal multipotent cell transplantation on skin wound during abdominal wall repair compared to dermal fibro-
healing. J Surg Res 2004;121(1):13–9 blasts. Wound Repair Regen 2004;12(5):539–45
11. Robson MC. Cytokine manipulation of the wound. Clin 27. Robson MC, Mustoe TA, Hunt TK. The future of recom-
Plast Surg 2003;30(1):57–65 binant growth factors in wound healing. Am J Surg
12. Fliniaux I, Viallet JP, Dhouailly D, Jahoda CA. Transforma- 1998;176(suppl 2A):80–2
tion of amnion epithelium into skin and hair follicles. 28. Cromack DT, Sporn MB, Roberts AB, Merino MJ, Dart LL,
Differentiation 2004;72(9-10):558–65 Norton JA. Transforming growth factor beta levels in rat
13. Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell wound chambers. J Surg Res 1987;42:622–8
characteristics of amniotic epithelial cells. Stem Cells
2005;23(10):1549–59
14. Tahara M, Tasaka K, Masumoto N et al. Expression of
messenger ribonucleic acid for epidermal growth factor Discussion
(EGF), transforming growth factor-alpha (TGF alpha), and
EGF receptor in human amnion cells: possible role of TGF
alpha in prostaglandin E2 synthesis and cell proliferation. Amid: Now we have more than 250 meshes, and
J Clin Endocrinol Metab 1995;80(1):138–46 our challenge remains the same. So I think it’s time
15. Padowska E, Blach-Olszewska Z, Gejdel E. Constitutive to [take the] focus from the mesh to the host. And
and induced cytokine production by human placenta and that is what you are doing.
amniotic membrane at term. Placenta 1997;18:441–6
Franz: Thank you.
16. Denison FC, Kelly RW, Calder AA, Riley SC. Cytokine secre-
tion by human fetal membranes, decidua and placenta at Klinge: I am not really convinced about the clas-
term. Hum Reprod 1998;13(12):3560–5 sification into big and small recurrences. I think if
17. Wu ZY, Hui GZ, Lu Y, Wu X, Guo LH. Transplantation of you create a wound within the abdominal wound,
human amniotic epithelial cells improves hindlimb func-
52 tion in rats with spinal cord injury. Chin Med J (Engl )
you always have an immigration of stem cells. Do
you have any information that in patients with
2006;119(24):2101–7
18. Franz MG, Smith PD, Wachtel TL et al. Fascial incisions
impaired wound healing it is this process of adult
heal faster than skin: a new model of abdominal wall local stem cells that is impaired? And correspond-
repair. Surgery 2001;129(2):203–8 ingly, these patients would benefit from some ad-
19. Dubay DA, Wang X, Adamson BS, Kuzon Jr WM, Den- ditional stem cells?
nis RG, Franz MG. Progressive fascial wound failure
Franz: There is evidence in the literature that the
impairs subsequent abdominal wall repairs: a new
animal model of incisional hernia formation. Surgery
amount of defect in the primary laparotomy will
2005;137(4):463–71 predict late incisional hernia—it was published in
20. Dubay DA, Choi W, Urbanchek MG, Kuzon WM, Franz MG. the British Journal of Surgery in 1989. The authors
Incisional herniation induces decreased abdominal wall were able to predict the future incisional hernia
compliance via oblique muscle atrophy and fibrosis. Ann based on the size of the hernia defect. Thus, it may
Surg 2007;245(1):140–6
21. Adinolfi M, Akle CA, McColl I et al. Expression of HLA
matter.
antigens, beta 2-microglobulin and enzymes by human Miserez: Congratulations on this wonderful lec-
amniotic epithelial cells. Nature 1982 28;295(5847):325–7 ture. You used human stem cells in the rat model.
22. Akle CA, Adinolfi M, Welsh KI, Leibowitz S, McColl I. Im- Should we work on interspecies in the future, or
munogenicity of human amniotic epithelial cells after should we stay in one species, with autologous
transplantation into volunteers. Lancet 1981 7;2(8254):
material?
1003–5
23. Sankar V, Muthusamy R. Role of human amniotic epi- Franz: It is possible. In practical surgery it is nice
thelial cell transplantation in spinal cord injury repair to have a product that is available. It may not mat-
research. Neuroscience 2003;118(1):11–7 ter what the species is.
Chapter 52 · The Role of Stem Cells in Abdominal Wall Repair
409 52
Schumpelick: Have you done experiments with Conclusion of Session IV,
fibroblasts? by A. Montgomery
Franz: No. There is a group from Israel that has
done that on mesh. The session included both experimental investi-
gations and studies and discussions. First of all,
we had a good overview of the pathophysiology
of the peritoneum and adhesion formation. Then
we had a discussion on meshes in general and on
biological meshes. I would say that the knowledge
of meshes today is a mess. We are talking about
shrinkage and expansion of meshes. The biological
meshes have brought something new; we now have
13 FDA-approved biological meshes. There are a
lot of things to study. What is the body’s reaction
to these meshes? When to use them? Or should we
use them at all?
There is a lot of work to be done. I would com-
bine that with a congratulation to the last lecture
on stem cell biology and the possible new think-
ing. It might be a combination for the biological
meshes—to overbridge a distance of about 20 cm
with stem cell formation. This might be a future
for the biological meshes. We also should concen-
trate on the effect of pore size. I also think that
the surface area was a very interesting key in the
discussion of meshes.
With regard to the clinical part and laparos-
copy, we could conclude that there is a total lack
of evidence for any mesh to be used and in what
situations. Better hernia classifications and hernia
registries would enable more precise research.
V

V Risk for Migration and Erosion

53 Safety and Durability of Prosthetic Repair of the Hiatal Hernia:


Lessons Learned from a 15-Year Experience – 413

54 Mesh Migration into the Esophageal Wall After Mesh


Hiatoplasty – 421

55 Complications After Gastric Banding–Results in


Germany – 429

56 Alloplastic Implants for the Treatment of Stress Urinary


Incontinence and Pelvic Organ Prolapse – 439

57 Prophylactic IPOM Mesh To Prevent Parastomal


Hernias – 445

58 Laparoscopic Parastomal Hernia Repair:


Pitfalls and Complications – 451

59 Concept of Visible Mesh and Possibilities for Analysis


of Mesh Migration and Shrinkage – 457
53

Safety and Durability of Prosthetic


Repair of the Hiatal Hernia: Lessons
Learned from a 15-Year Experience
P. von Ryll Gryska
414 Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia: Lessons Learned from a 15-Year Experience

Introduction

Laparoscopic fundoplication has emerged as the


gold standard for treating refractory reflux disease
and symptoms of gastric herniation. Surgical suc-
cess rates as measured by patient satisfaction and
symptom relief have been reported to be between
85% and 95% [1, 2]. However, as with any op-
eration, we should continue to critically examine
clinical failures in an effort to identify and correct
a
potential sources of technical weaknesses.
There are several important technical features
of standard hiatal hernia repair/fundoplication, in-
cluding hernia sac excision, mobilization of the
esophagus, return of the stomach and distal esoph-
agus to the intraabdominal position, and crural re-
pair and wrap. Each has been recognized as an im-
portant feature of a successful clinical outcome [3].
Breakdown of the hiatal hernia repair has also been
recognized as a common cause for clinical failure,
often within the first 2 years, leading to wrap her-
niation and paraesophageal herniation and contrib- b
uting to the slipped Nissen phenomenon [4–6].
During the last 15 years, we have focused on ⊡ Fig. 53.1. a Staples and suture to right crus after crural clo-
hiatal hernia repair as a source of technical failure. sure. b Staples and suture to left crus
A prosthetic patch of the esophageal defect or rein-
forcement of the crural closure was used on all pa-
tients. With experience, the technique has evolved diaphragm [7]. The next 105 patients (group B)
from a pure nontension patch of the hiatal defect to underwent hiatal hernia repair using an ePTFE/
partial crural closure with sutures reinforced with PTFE prosthesis (CruraSoft; Davol/Bard). Fixa-
53 an expanded polytetrafluoroethylene (ePTFE)/ tion of this prosthesis as part of the crural closure
PTFE prosthesis stapled and sutured into position evolved quickly to partial crural closure with one
to prevent motion, migration, or erosion. In short, to three sutures and fixation of the prosthesis with
the crural closure is treated as a hernia repair any- staples (EMS 20; Ethicon) and 2-0 silk sutures
where else on the abdominal wall. Presented here (⊡ Fig. 53.1). The prosthesis was positioned onto
are the lessons learned about the fixation, durabil- the crural closure so that none of the material was
ity, and safety of prosthetic mesh at the hiatus. abutting the esophagus. This required thorough
esophageal mobilization and complete dissection
of the crural columns posteriorly.
Materials and Methods The focus of the record review was on short-
term and long-term safety as well as durability
Records of 217 patients undergoing laparoscopic of the prosthetic crural repair. Postoperative dys-
Nissen fundoplication were examined. Each pa- phagia, stricture, integrity of the crural repair, re-
tient had a prosthetic closure of the hiatal hernia herniation, and development of long-term compli-
or reinforcement of the crural repair. The first 112 cations were examined. Continuing analysis and
patients (group A) had a nontension patch using retrospective review then permitted evaluation of
a PTFE mesh stapled into position with 3 cm of the crural repair and fixation techniques that led to
mesh overlapping beyond crural bundles onto the the best clinical outcomes.
Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia
415 53
Results
⊡ Table 53.1. Patient demographics

Beginning in November 1993, 217 patients under- 217 patients, 120 female, ages 19–87 (mean 57.5 years)
went laparoscopic Nissen fundoplication with a
Mean operating time: 155 min
nontension prosthetic closure of the hiatal defect
(group A =112 patients) or prosthetic reinforce- Pure paraesophageal hernias: 22 (10%)
ment of the hiatal hernia repair (group B =105 Large hiatal defects ≥6 cm: 75 patients (34.5%)
patients).
Mean age with large defects: 69.7 years
Patient demographics are listed in ⊡ Table 53.1.
Of note is the large number of type II and type III Mean operating time (large defects): 205 min
hiatal hernias, with 75 patients having »large«
hiatal defects >6 cm. Twenty-two patients (10%)
underwent concomitant cholecystectomy, and 11
patients were referred for recurrent hiatal hernias ture disease. Five patients in group A required
(2–26 years postoperative). two to four dilations. One patient developed a
fibrous stricture of the esophageal hiatus 4 years
after initial surgery and required reoperation.
Short-Term Safety This patient had no intraluminal pathology or
erosion. Five of 17 primary postoperative dys-
There were no deaths, no transfusions, and no in- phagia patients were from group B, each requir-
traabdominal or mediastinal infections. There was ing only one dilation.
no tearing or disruption of crural tissues. Place-
ment of the prosthetic patch or reinforcement took
3–5 min when staples alone were used. Adding Long-Term Safety
two sutures to the fixation process added roughly
8–10 min to the procedure. There were 165 patients for whom data since No-
Although most operations were class I, to- vember 1993 were available. Data were available
tally clean procedures without violation of the on all group B patients. The mean follow-up was
gastrointestinal tract, 10% of the patients had a 71 months (6–173 months). Barium studies on
cholecystectomy at the same time. One gastro- 90 patients done 1 day to 8 years postoperatively
tomy occurred during a redo operation, which (mean 38 months) found no impingement of the
was closed immediately without contamination, prosthesis onto the esophagus or stomach, and
and one Collis–Nissen esophageal lengthening was 116 endoscopies on 86 patients (8 weeks to 8 years
performed. These events officially made these cases postoperatively; mean 42 months) found no ero-
class II, clean-contaminated operations. Three uri- sion or impingement. In the years since their index
nary tract infections, two cases of cellulitis at an surgery, six patients have undergone cholecystec-
intravenous line site, three pneumonias (in large tomy, two for acute disease; two patients had ap-
paraesophageal hernias), a port site infection, and pendicitis; and five patients have been treated for
sinusitis were treated aggressively. Sixteen post- diverticulitis. Nine other patients have had in-
operative fevers were related to atelectasis. There traabdominal surgery, and two have had thoracic
were no complications related to PTFE mesh fixa- surgery. One patient had an esophagectomy for
tion with staples or sutures. progressing Barrett’s, during which the pure mesh
Dysphagia to solid foods occurred routinely prosthesis was found to be thoroughly ingrown to
in the 1st month after surgery, and patients were the crus and required excision with scissors to al-
kept on a liquid or very soft diet. Dysphagia low room for the gastric tube [7]. Two patients had
requiring endoscopic dilation after 6 weeks oc- full-term pregnancies, with one cesarean section.
curred in 36 patients (12%). Nineteen of these 36 There have been no mesh infections and no mesh
patients had had preoperative dilatation for stric- erosions.
416 Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia: Lessons Learned from a 15-Year Experience

Durability as »easy to handle at laparoscopy, able to adhere


to the diaphragmatic surface on one side and be
Failure of the hiatal hernia repair as determined by benign to visceral surface on the other« [12]. The
symptoms and/or x-ray findings of wrap herniation next challenge is to position the prosthesis prop-
occurred in three patients (1.4%). Two required erly and then secure it properly.
reoperation. Hiatal hernia disruption occurred, re- Several authors have shown that disruption of
spectively, at 5 days, 2 weeks, and 2 months after the crural closure occurs frequently in the early
surgery. The earliest failure, at 5 days, was a totally postoperative months to years [13–16]. Filipi has
nontension PTFE repair (group A) and occurred shown that various »stressors« or intraabdominal
after heavy lifting. The other two were technical pressures can predispose to crural disruption [17].
failures in which the preshaped PTFE/ePTFE mesh Meshed prostheses do become ingrown into the
was merely stapled to the left and right crus without crural muscle with time [7]. Our clinical failures
crural closure and without sutures. In all subsequent even with a prosthesis occurred within the first
patients (101 patients), the crura were closed par- 2 months after a nontension repair and therefore
tially or tightly to a 58-Fr bougie, and the prosthesis are considered failures of fixation.
was secured in position with staples and sutures. In subsequent patients, then, the crus was
All 217 patients underwent laparoscopic Nis- closed with one to three sutures, depending on
sen fundoplication after crural repair with a pros- the size of the defect, to provide backing to the
thesis. In total, there have been three reoperations: mesh and to provide substrate for staples, and
one for stricture developing 4 years after the initial sutures were added to the fixation to provide extra
surgery and two for disruption of the crural repair strength and prevent prosthetic movement until
with wrap migration. tissue ingrowth could occur.
The one late-occurring stricture and one crural The problem of erosion was not seen in this
disruption occurred in group A, the totally non- series over 15 years, and yet there are scattered pub-
tension group. Two disruptions of the crural repair lished reports of such and anecdotal reports (un-
occurred in group B before we learned to close the published) to this author. Erosion could result from
crus as a backing for the prosthesis and to suture improper placement of the prosthesis, i.e., placing
as well as staple the prosthesis in place. Since the the prosthesis too far anterior and abutting the
development of crural closure and suture fixation esophagus, which may not be mobilized fully from
along with staples, there have been no crural dis- its posterior position. Erosion could also result from
53 ruptions or reherniations in the last 101 patients migration and motion of a free-floating prosthesis
(follow-up 6–55 months). (e.g., Angelchik). For these reasons, the prosthesis is
now fixed to a closed crural defect with sutures and
staples and is positioned so that the esophagus does
Discussion not touch any part of the prosthesis. The posterior
wrap then further pulls the esophagus anteriorly
It is recognized that disruption of the crural clo- and away from the crural repair.
sure leads to wrap herniation and clinical failure. Short-term safety and avoidance of infection
It should not surprise us that a primary tension related to the prosthesis at the hiatus are really
closure of the crural pillars can fail. The crural pil- a function of careful surgical technique and po-
lars are pure muscle: There is no substantial fascia, sitioning of the prosthesis on well-vascularized
no tendinous tissue, and no ligamentous fibers, crural muscle. In our review, no intraabdominal
and nowhere else in surgery do we close muscle or mediastinal infections were encountered despite
to muscle and expect it to hold under tension. 24/217 clean-contaminated procedures and 10 pe-
The myriad of studies [8–11] that show improved ripheral postoperative infections.
integrity of crural repair after prosthetic reinforce- Dysphagia after 6 weeks occurred, not sur-
ment force us to examine the next step: how to do prisingly, in 19 patients who had required dila-
it safely. Granderath et al. define the ideal mesh tion preoperatively. In 17/217 patients, primary
Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia
417 53
postoperative dysphagia was treated with dilation crus in a full-thickness fashion further secure the
and seemed more a consequence of the wrap and prosthesis and prevent long-term migration and
postoperative scar retraction or motility issues erosion (⊡ Fig. 53.1). Suturing of the stomach, the
than narrowing of the esophageal hiatus. Among wrap, or the esophagus to the prosthesis is to be
group B patients, only 5/105 had late postoperative avoided.
dysphagia consistent with primary crural closure Durability of the hiatal hernia repair using a
or mesh at the hiatus. Only one patient had clini- prosthesis has also been quite satisfactory in this
cally significant hiatal scarring, resulting in late experience. In three patients, breakdown occurred
dysphagia at 4 years. This rare phenomenon is at 5 days, 2 weeks, and 2 months, respectively. Two
known to occur historically with primary closure patients underwent subsequent repair with pros-
alone and is poorly understood. theses. The very early failure was a consequence
Long-term safety after 15 years is quite satisfac- of extreme Valsalva at postoperative day 5 on a
tory. Despite intraabdominal infections from sub- nontension repair. The next two breakdowns were
sequent disease and other elective clean-contami- a failure of proper fixation, in which the PTFE/
nated operations, the prosthetic meshes placed at ePTFE prosthesis was merely stapled to the cru-
the hiatus are not susceptible to bacterial seeding. ral columns without closure (also nontension).
Just as prostheses on the anterior abdominal wall It quickly became apparent that crural backing
are covered with a protective peritoneal covering, was necessary for secure fixation as well as for
so too is the prosthesis at the hiatus [18]. Proper long-term tissue ingrowth. The technique evolved
positioning and proper fixation of the prosthe- quickly and incorporated fixation sutures on ei-
sis have prevented migration, impingement, and ther side of the prosthesis, incorporating the full-
erosion into the esophagus. The smooth ePTFE thickness crural column and the inner aspect of
surface of the patch used on the most recent 105 the prosthesis (⊡ Fig. 53.1).
patients prevents tissue ingrowth and thereby pre- Now, after 15 years, 214 of 217 patients have
vents fistulization to the stomach. had successful long-term treatment of their hiatal
In a primary crural closure, one would not hernias. The hiatal hernia repairs remain intact
expect to see the top of the closure or the suture after initial experience using a nontension pros-
impinging on the esophagus at barium study or thetic repair (111 patients) or subsequent experi-
endoscopy. Similarly, with a properly placed pros- ence with 101 patients in whom a primary crural
thetic patch reinforcing the crural closure, no im- repair was reinforced with a PTFE/ePTFE prosthe-
pingement was seen on barium study (90 patients) sis. The PTFE/ePTFE prosthesis was thought to be
or endoscopy (116 endoscopies in 86 patients). safer with the ePTFE surface facing the viscera and
This, too, is a consequence of proper placement thereby preventing tissue ingrowth and erosion.
and proper fixation of the prosthesis as well as Seventy-five patients in this series had hiatal
thorough mobilization of the posteriorly seated defects measuring 6 cm or greater. This large per-
intrathoracic esophagus. This mobilization is nec- centage of type II and type III hernias (34%) re-
essary to return the distal 2–3 cm of the esophagus flects an aging population (the mean age of this
to the intraabdominal position, and it helps lift the subset was 69 years), the increasing use of en-
esophagus anteriorly away from the crural closure doluminal therapies for small hiatal hernias, and
and any prosthetic reinforcement. The bulky pos- a continuing reluctance of gastroenterologists to
terior wrap further holds the esophagus anteriorly surrender pure reflux disease that can be medi-
away from the top of the closure. Most often, the cally managed. This 15-year experience hopes to
prosthesis is placed below the top of the crural clo- show that hiatal hernia repair can be made durable
sure. The approximated hiatal closure provides a with the use of prosthetic reinforcement and can
substrate behind the mesh for both near-term fixa- be done safely using lessons learned from other
tion with staples and long-term tissue ingrowth. prosthetic hernia repairs.
The fixation with 15–20 staples (not tacks) and The superiority of prosthetic repair has been
the addition of two sutures to fix the mesh to the demonstrated in numerous studies over the last
418 Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia: Lessons Learned from a 15-Year Experience

cruroplasty for large hiatal hernia. Arch Surg 137(6):649–


⊡ Table 53.2. Review articles of studies comparing pri- 652
mary crural closure vs. prosthetic hiatal hernia repair 7. Gryska PV, Vernon JK (2005) Tension-free repair of hiatal
hernia during laparoscopic fundoplication: a ten-year ex-
Authors Year Number of patients perience. Hernia 9(2):150–155
8. Turkcapar A, Kepenekci I, Mahmoud H, Tuzuner A (2007)
Targarona et al. [19] 2004 480
Laparoscopic fundoplication with prosthetic hiatal clo-
Granderath et al. [12] 2006 766 sure. World J Surg 31(11):2168
9. Müller-Stich BP, Holzinger F, Kapp T, Klaiber C (2006) Lap-
Johnson et al. [20] 2006 639 aroscopic hiatal hernia repair: long-term outcome with
the focus on the influence of mesh reinforcement. Surg
Endosc 20(3):380–384
10. Lee YK, James E, Bochkarev V, Vitamvas M, Oleynikov D
(2008) Long-term outcome of cruroplasty reinforcement
decade and includes three review articles (⊡ Ta-
with human acellular dermal matrix in large paraesopha-
ble 53.2) [12, 19, 20]. With thousands of patients in geal hiatal hernia. J Gastrointest Surg 12(5):811–815
hundreds of studies, ethically the time has passed 11. Granderath FA, Schweiger UM, Kamolz T, Pasiut M, Haas
for randomization of primary repair versus pros- F, Pointner R (2002) Laparoscopic antireflux surgery with
thetic repair of hiatal hernia. Although there are routine mesh-hiatoplasty in the treatment of gastroe-
sophageal reflux disease. J Gastrointest Surg 6(3):347–
surgeons who are capable of tailoring crural repair
353
to the individual patient [21], it may be safer for 12. Granderath FA, Carlson MA, Champion JK, Szold A, Basso
the general surgeon at large if we as a community N, Pointner R, Frantzides CT (2006) Prosthetic closure of
can further define the best practice. Prosthetic the esophageal hiatus in the large hiatal hernia repair
reinforcement of the crural repair should now be and laparoscopic anti reflux surgery. Surg Endosc 20:367–
379
considered the standard of care. Remaining chal-
13. Endzinas Z, Jonciauskiene J, Mickevicius A, Kiudelis M
lenges include the ideal prosthesis, proper posi- (2007) Hiatal hernia recurrence after laparoscopic fun-
tioning, and proper fixation. doplication. Medicina (Kaunas) 43(1):27–31
14. Hatch KF, Daily MF, Christensen BJ, Glasgow RE (2004)
Failed fundoplications. Am J Surg 188(6):786–791
References 15. Hunter JG, Smith CD, Branum GD, Waring JP, Trus TL,
Cornwell M, Galloway K (1999) Laparoscopic fundoplica-
tion failures: patterns of failure and response to fundopli-
1. Terry M, Smith DC, Branum GD, Galloway K, Waring JP, cation revision. Ann Surg 230(4)595–606
Hunter JG (2001) Outcomes of laparoscopic fundoplica- 16. Filipi CJ (2000) Laparoscopic hiatal hernia repair: why
53 tion for gastroesophageal reflux disease and paraesopha- they fail. Hernia 4:219–222
geal hernia. Surg Endosc 15:691–699 17. Kakarlapudi G, Awad Z, Haynatzki G, Sampson T, Stroup
2. Cowgill SM, Gillman R, Kraemer E, Al-Saadi S, Villadolid D, G, Filipi CJ (2002) The effect of diaphragmatic stressors on
Rosemurgy A (2007) Ten-year follow up after laparoscopic recurrent hiatal hernia. Hernia 6:163–166
Nissen fundoplication for gastroesophageal reflux dis- 18. Amid P, Shulman A, Lichtenstein I, Hakakha M (1994)
ease. Am Surg 73(8):748–752 Biomaterials for abdominal wall hernia surgery and
3. Cuschieri A, Shimi S, Nathanson LK (1992) Laparoscopic principles of their applications. Langenbeck Arch Chir
reduction, crural repair, and fundoplication of large hiatal 379:168–171
hernia. Am J Surg 163:425 19. Targarona EM, Bendaham G, Balague,C, Garriga J, Trias M
4. Basso N, De Leo A, Genco A, Rosato P, Rea S, Spaziani E, (2004) Mesh at the hiatus. Arch Surg 139:1286–1296
Primavera A (2000) 360 degrees laparoscopic fundopli- 20. Johnson JM, Carbonell AM, Carmody BJ, Jamal MK, Maher
cation with tension-free hiatoplasty in the treatment of JW, Kellum JM, DeMaria EJ (2006) Laparoscopic mesh
symptomatic gastroesophageal reflux disease. Surg En- hiatoplasty for paraesophageal hernias and fundoplica-
dosc 14(2):164–169 tions: a critical analysis of the available literature. Surg
5. Kamolz T, Granderath FA, Bammer T, Pasiut M, Pointner Endosc 20:362–366
R (2002) Dysphagia and quality of life after laparoscopic 21. Granderath FA, Schweiger UM, Pointner R (2007) Laparo-
Nissen fundoplication in patients with and without pros- scopic antireflux surgery: tailoring the hiatal closure to
thetic reinforcement of the hiatal crura. Surg Endosc the size of the hiatal surface area. Surg Endosc 21:1900
16:572–577
6. Frantzides CT, Madan AK, Carlson MA, Stavropoulos GP
(2002) A prospective, randomized trial of laparoscopic
polytetrafluoroethylene (PTFE) patch repair vs simple
Chapter 53 · Safety and Durability of Prosthetic Repair of the Hiatal Hernia
419 53
Discussion

Fitzgibbons: I did not hear your failure rate. You


told us a lot of information,but what was your
failure rate?
Gryska: Within this study I put the data together,
and we had a clinical success rate equivalent to
standard reflux surgery. We have a 92–93% clinical
success rate.
Fitzgibbons: The only thing I want to say is that
we recently presented 25 cases of erosion.
Gryska: I was unaware of that.
Fitzgibbons: We collected them from all around
the country.
Gryska: I found six in the literature and three an-
ecdotal.
Fitzgibbons: And we found all types of materials,
including biologicals. Surgisis, GoreTex, anything
you can imagine.
Gryska: We should take this message and pay at-
tention to hernia and keep the prosthetic away
from the esophagus.
Flament: I am glad that Dr. Fitzgibbons said this.
Because in our department within the last 2 years
we had two cases of prosthesis migrating, and I
cannot imagine having 25% of the world cases.
There are a lot of cases never reported, and that is
probably the case for most of the complications in
every field of surgery.
Gryska: I believe you are right. We just see the tip
of the iceberg and have not yet come across the
perfect mesh, the perfect way of fixating the mesh.
I think as hernia surgeons we have to think about
a better way.
Schumpelick: Thank you for the comments. The
reason we put this topic on the agenda was because
2½ years ago we had the topic of incisional hernia
here in Suvretta, and we had all the cracks of hiatal
hernia here, but we did not get a real solution on
how to handle it. Now we see good clinical results.
54

Mesh Migration into the Esophageal


Wall After Mesh Hiatoplasty
M. Jansen and J. Otto
422 Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty

Introduction

Because of recurrence rates of up to 42% after Nis-


sen fundoplication, the implantation of prosthetic
material is recommended in cases of paraesopha-
geal herniation [1, 2]. Clinical studies of patients
with gastroesophageal reflux disease have shown
that the recurrence of symptoms is mainly caused
by intrathoracic herniation of the gastric wrap into
the mediastinum [3–5]. Since the first descrip-
tion of hiatal mesh implantation by Kuster and
Gilroy [6], many different techniques have been a

published [7]. Although large series of patients


were treated, a good understanding of indications,
mesh placement technique, mesh structure, and
mesh material is still lacking. Most studies deal
with the clinical outcome, such as dysphagia or
recurrence rate. Only a few case reports give an
account of mesh migration and perforation into
the esophagus [8, 9]. One current article by Desai
and colleagues deals with histological results 1 year
after bioprosthetic repair of paraesophageal her-
nia with a new small intestinal submucosal (SIS)
mesh. The authors found no evidence of erosion
of SIS mesh into the esophagus [10]. To examine
b
functional and histological changes in the distal
esophagus after implantation of two different al-
⊡ Fig. 54.1. a Polypropylene–polyglecaprone 25 composite
loplastic mesh materials, we performed an animal mesh fixed to the esophageal hiatus, intraoperative view.
study in rabbits. b Polypropylene mesh fixed to the esophageal hiatus, intra-
operative view

Materials and Methods


54 hiatus as an anterior onlay patch overlapping the
Animals and Anesthesia hiatal crura with a circular distance to the esopha-
geal wall of 3 mm. The meshes had a diameter of
A total of 20 female chinchilla rabbits (mean body 2 cm and were fixed to the diaphragm with four
weight 2.5±0.3 kg) were included in this study. polypropylene (6-0) single stitches (⊡ Fig. 54.1).
The rabbits were randomly assigned to two dif- The abdominal cavity was closed with two running
ferent groups of equal numbers. The surgical pro- sutures of 3-0 polyglycolic acid.
cedure was performed under sterile conditions
and general anesthesia by intravenous administra-
tion of ketamine 10% (Sanofi-Ceva, Dusseldorf, Functional Analysis
Germany) and xylazine (Rompun 2%; Bayer, Le-
verkusen, Germany) [11, 12]. After 3 months the animals received general an-
The stomach and the distal esophagus were ex- esthesia again. A small gastric tube (6 Ch) was
posed. Two different meshes–polypropylene (PP; inserted into the proximal esophagus, and water-
Prolene) and a polypropylene–polyglecaprone 25 soluble iodine contrast medium was injected very
composite (PP-PG; UltraPro)–were placed on the carefully into the esophagus until deglutition was
Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty
423 54
initiated. The swallow was documented by con- Statistical Analysis
tinuous radioscopy.
All data are expressed as mean ± standard error of
the mean (SEM). Wilcoxon’s two-sample test was
Macroscopic Analysis used for statistical analysis. Differences were con-
sidered statistically significant when p<0.05.
The animals were killed by a lethal dose of pen-
tobarbital sodium (Narcoren; Rhone Merieux,
Laupheim, Germany). The abdominal cavity was Results
reopened via a U-shaped incision in the upper ab-
domen for complete exploration. Adhesions to the The initial surgical procedure was uneventful in all
mesh were examined and photo-documented, and animals. Sixteen rabbits survived the complete ob-
the severity was registered according to a scoring servation period of 3 months. Four animals (three
system [13, 14]. with PP, one with PP-PG) died of pneumonia. We
found no complications caused by the surgical
procedure.
Histochemistry and
Immunohistochemistry
Contrast Medium Swallow
The distal esophagus and the diaphragm includ-
ing the implanted mesh were resected en bloc and After 3 months we found a prolonged passage of
fixed in formaldehyde solution, and 5-μm sagittal contrast medium into the stomach in all oper-
sections were then stained with hematoxylin and ated animals, which was associated with a prest-
eosin (H&E). Light microscopy was used to evalu- enotic dilatation of the distal esophagus. However,
ate the foreign body reaction, localization of the fluid passage was possible in all cases. A complete
mesh as related to the esophageal wall, and extent stenosis was not observed. The dilatation aver-
of esophageal stenosis. aged 1.2±0.5 cm in the PP group compared with
The foreign body reaction was analyzed quan- 1.0±0.3 cm in the PP-PG group (p=0.37; ⊡ Fig. 54.2).
titatively by measuring the diameters of the for-
eign body granuloma surrounding the mesh fila-
ments. In brief, the granulomas were subdivided
into »inner ring« granuloma, representing the
inflammatory infiltrate, and »outer ring« granu-
loma, resulting from the fibrotic tissue reaction.
After five granulomas per sample were captured
with a digital camera (×400, Olympus C-3030,
Hamburg, Germany), separate measurements of
four quadrants of the inner and outer granuloma
ring were made with the help of digital image-
analyzing software (Image-Pro Plus; Media Cy-
bernetics, Silver Spring, MD, USA) [15]. The mi-
gration of the mesh into the esophageal wall was
characterized as follows: 0= no contact between
mesh and esophagus; 1= mesh migration into the
outer longitudinal muscle; 2= mesh migration into
the inner circular muscle; 3= mesh migration into ⊡ Fig. 54.2. Swallow of water-soluble iodine contrast medi-
the submucosal layer; 4= mesh migration into the um with esophageal dilatation due to polypropylene mesh
esophageal lumen. implantation
424 Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty

Histology
80

We measured the granuloma diameter at the graft– 70


tissue interface close to the esophagus as well as
close to the diaphragm in order to evaluate the ex- 60
tent of foreign body reaction. The diameter of the

Diameter [μm]
inner ring close to the esophagus, representing the 50
inflammatory infiltrate, was similar in both groups.
40
The mean diameter was 19.2±1.9 μm after implan-
tation of PP-PG mesh compared with 18.3±2.4 μm 30
for the PP mesh (p=0.4). In contrast, we observed a
significant increase in the outer ring of granuloma 20
in the PP group (76.5±8.0) compared with the
10
PP-PG group (64±8.5, p=0.002; ⊡ Fig. 54.3a, b).
a 0
inner granuloma outer granuloma
Mesh Migration Ultrapro Prolene

After 3 months, distinctive mesh shrinkage was ob- 90


served in all animals, and meshes lost up to 50% of
their original size (⊡ Fig. 54.4a, b). Because the con- 80

tiguity to the distal esophagus was of paramount 70


interest, we focused on the mesh migration into
60
the esophageal wall. Only one of the implanted PP
Diameter [μm]

meshes was located within distance of the esopha- 50


geal wall. Three (43%) meshes moved into the
40
outer longitudinal muscle layer. Two (29%) were
detected in the inner circular muscle layer. One 30
(14%) mesh had perforated the muscle layer and
20
migrated into the submucosa.
The results for the PP-PG meshes were signifi- 10
cantly different: Four (44%) meshes were located
b 0
54 outside the esophageal wall, while three (30%) inner granuloma outer granuloma
were detected in the outer longitudinal muscle and
Ultrapro Prolene
two (22%) in the inner circular muscle layer.
It must be pointed out that both types of mesh
⊡ Fig. 54.3. a Diameter of inner and outer granuloma at the
left their implantation bed and migrated into the diaphragm after implantation of polypropylene (Prolene)
esophageal wall (⊡ Fig. 54.5). and polypropylene–polyglecaprone 25 composite (UltraPro)
mesh. b Diameter of inner and outer granuloma at the eso-
phagus after implantation of polypropylene (Prolene) and
Discussion polypropylene–polyglecaprone 25 composite (UltraPro) mesh

Johnson et al. [7] reviewed the literature on lap-


aroscopic mesh hiatoplasty and concluded that polytetrafluoroethylene [20, 21], Surgisis [22], Al-
current data »tend to support the use of prosthetic loderm) were used, and the current data focus only
materials for hiatal repair.« Nevertheless, different on the clinical outcomes.
techniques (anterior–posterior, onlay interposi- However, data concerning implantation of al-
tion) and mesh materials (polypropylene [16–19], loplastic material for repairing incisional hernias
Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty
425 54

a a

b b

⊡ Fig. 54.4. a Polypropylene–polyglecaprone 25 composite ⊡ Fig. 54.5. a Hematoxylin and eosin (H&E) staining of the
mesh 3 months after implantation; adhesion to the liver distal esophagus (magnification ×40) with submucosal de-
and stomach was removed. b Polypropylene mesh 3 months tection of mesh fibers (polypropylene). b H&E staining of the
after implantation; adhesion to the liver and stomach was distal esophagus (magnification ×40) with detection of mesh
removed fibers (polypropylene–polyglecaprone 25 composite) within
the longitudinal esophageal muscle layer

show the superiority of reduced-material meshes mesh materials used for the repair of hiatal hernias
with large pores to minimize the inflammatory have not yet been shaped. Case reports indicate the
response and scar formation [23–26]. Extensive problem of mesh migration into the esophagus,
work has led to several mesh modifications to and, to the author’s knowledge, several oral reports
adapt to physiological requirements and improve on this topic were presented at different meetings
biocompatibility [15, 27, 28]. In particular, the in recent years. These reports may underscore the
drawbacks of PP mesh implantation have been elu- necessity to analyze the biological and functional
cidated and have led to mesh modifications such as outcomes of meshes used for hiatoplasty [9, 32].
combined mesh materials [28–30]. A first attempt at mesh modification was done
A new composite mesh consisting of a reduced by Desai et al. [10]. The researchers found that
amount of polypropylene supplemented with poly- implanting a small intestinal submucosal mesh led
glecaprone 25 minimizes the development of gran- to good reinforcement of the hiatus with marginal
ulomatous chronic foreign body reaction. Polygle- foreign body reaction and native ingrowth of con-
caprone 25 filaments were essentially degraded nective tissue and skeletal muscle. However, this
84 days after implantation [31]. Requirements for type of mesh is not used widely in clinics.
426 Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty

The results of our experiments clearly indi- into the esophagus nine years after Nissen fundoplica-
cate that circular implantation of meshes around tion. Gastrointest Endosc 2000 May; 51(5):607–10
9. Gajbhiye R, Quraishi AH, Mahajan P, Warhadpande M.
the esophagus leads to a high rate of mesh mi-
Dysphagia due to transmural migration of polypropylene
gration. Furthermore, heavyweight polypropyl- mesh into esophagus. Indian J Gastroenterol 2005 Sep;
ene meshes are less compatible compared with 24(5):226–7
lightweight composite mesh (PP-PG). We found a 10. Desai KM, Diaz S, Dorward IG, Winslow ER, La Regina MC,
higher rate of migration into the esophageal wall Halpin V, Soper NJ. Histologic results 1 year after biopros-
thetic repair of paraesophageal hernia in a canine model.
and an increased extent of foreign body reaction
Surg Endosc 2006 Nov; 20(11):1693–7
with PP mesh compared with the PP-PG mesh. 11. Treutner KH, Bertram P, Lerch MM, Klimaszewski M,
These results are consistent with the biology of Petrovic-Kallholm S, Sobesky J, Winkeltau G, Schumpelick
meshes used in the treatment of incisional her- V. Prevention of postoperative adhesions by single intrap-
nias [33–35]. Although the data were generated in eritoneal medication. J Surg Res 1995 Dec; 59(6):764–71
12. Muller SA, Treutner KH, Jorn H, Anurov M, Oettinger AP,
rabbits and have limited impact on humans, our
Schumpelick V. Phospholipids reduce adhesion forma-
presented animal model can be used to develop the tion in the rabbit uterine horn model. Fertil Steril 2002
necessary requirements for mesh hiatoplasty. More Jun; 77(6):1269–73
experimental data are necessary to assess the opti- 13. Zuhlke HV, Lorenz EM, Straub EM, Savvas V. [Pathophysi-
mal size, structure, and positioning of prosthetic ology and classification of adhesions]. Langenbecks Arch
materials for mesh hiatoplasty [36, 37]. Chir Suppl II Verh Dtsch Ges Chir 1990; 1009–16
14. Leach RE, Burns JW, Dawe EJ, SmithBarbour MD, Diamond
MP. Reduction of postsurgical adhesion formation in the
rabbit uterine horn model with use of hyaluronate/car-
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6(3):347–53 Pointner R, Frantzides CT. Prosthetic closure of the esopha-
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4. Hunter JG, Smith CD, Branum GD, Waring JP, Trus TL,
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ures: patterns of failure and response to fundoplication 19. Keidar A, Szold A. Laparoscopic repair of paraesophageal
revision. Ann Surg 1999 Oct; 230(4):595–604 hernia with selective use of mesh. Surg Laparosc Endosc
5. Carlson MA, Frantzides CT. Complications and results of Percutan Tech 2003 Jun; 13(3):149–54
primary minimally invasive antireflux procedures: a re- 20. Frantzides CT, Madan AK, Carlson MA, Stavropoulos GP. A
view of 10,735 reported cases. J Am Coll Surg 2001 Oct; prospective, randomized trial of laparoscopic polytetra-
193(4):428–39 fluoroethylene (PTFE) patch repair vs simple cruroplasty
6. Kuster GG, Gilroy S. Laparoscopic technique for repair of for large hiatal hernia. Arch Surg 2002 Jun; 137(6):649–52
paraesophageal hiatal hernias. J Laparoendosc Surg 1993 21. Hui TT, Thoman DS, Spyrou M, Phillips EH. Mesh crural
Aug; 3(4):331–8 repair of large paraesophageal hiatal hernias. Am Surg
7. Johnson JM, Carbonell AM, Carmody BJ, Jamal MK, Maher 2001 Dec; 67(12):1170–4
JW, Kellum JM, DeMaria EJ. Laparoscopic mesh hiato- 22. Oelschlager BK, Barreca M, Chang L, Pellegrini CA. The use
plasty for paraesophageal hernias and fundoplications: of small intestine submucosa in the repair of paraesopha-
a critical analysis of the available literature. Surg Endosc geal hernias: initial observations of a new technique. Am
2006 Mar; 20(3):362–6 J Surg 2003 Jul; 186(1):4–8
8. Arendt T, Stuber E, Monig H, Folsch UR, Katsoulis S. Dys- 23. Klosterhalfen B, Klinge U, Hermanns B, Schumpelick V.
phagia due to transmural migration of surgical material [Pathology of traditional surgical nets for hernia repair
Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty
427 54
after long-term implantation in humans]. Chirurg 2000 Discussion
Jan; 71(1):43–51
24. Schumpelick V, Klinge U, Welty G, Klosterhalfen B.
Kukleta: I would like to make a comment on the
[Meshes within the abdominal wall]. Chirurg 1999 Aug;
70(8):876–87 strategy of the team of Pointner and Granderath. It
25. Conze J, Klinge U, Schumpelick V. [Incisional hernia]. is a pity that they are not here, because they repre-
Chirurg 2005 Sep; 76(9):897–909 sent a very big experience in this field. It is obvious
26. Conze J, Kingsnorth AN, Flament JB, Simmermacher R, that they achieved good results with these very
Arlt G, Langer C, Schippers E, Hartley M, Schumpelick V.
small one to three hernias and a mesh placed pos-
Randomized clinical trial comparing lightweight compos-
ite mesh with polyester or polypropylene mesh for inci-
teriorly, and they improved their recurrence rate
sional hernia repair. Br J Surg 2005 Dec; 92(12):1488–93 immensely. And the number three and four are
27. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen obvious too, because for the very large paraesopha-
B, Schumpelick V. Do multifilament alloplastic meshes geal hernia, this was not enough. So the condition
increase the infection rate? Analysis of the polymeric
of the crura was responsible for the two branches.
surface, the bacteria adherence, and the in vivo con-
sequences in a rat model. J Biomed Mater Res 2002;
If the crura are fine, they rely on the crural suture
63(6):765–71 repair, and then they packed it posteriorly.
28. Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpelick The other ones are the desperate cases which
V. PVDF as a new polymer for the construction of surgical you nearly cannot suture, and nobody believes that
meshes. Biomaterials 2002 Aug; 23(16):3487–93 that region can be tension-free covered for such a
29. Conze J, Junge K, Klinge U, Weiss C, Polivoda M, Oettinger
AP, Schumpelick V. Intraabdominal adhesion formation of
long time, but there are several papers from Italy
polypropylene mesh. Influence of coverage of omentum where they placed a mesh circularly. Especially in
and polyglactin. Surg Endosc 2005 Jun; 19(6):798–803 the anterior part, the mesh gets very, very close to
30. Conze J, Rosch R, Klinge U, Weiss C, Anurov M, Titkowa S, the esophagus. In the posterior part you can get
Oettinger A, Schumpelick V. Polypropylene in the intra- the 1-cm distance, so you actually do not have any
abdominal position: influence of pore size and surface
contact from the mesh to the esophagus. And if
area. Hernia 2004 Dec; 8(4):365–72
31. Junge K, Rosch R, Krones CJ, Klinge U, Mertens PR, Lynen you do a fundoplication, it will cover the mesh.
P, Schumpelick V, Klosterhalfen B. Influence of polygle- Jansen: I totally agree, and I think the idea of
caprone 25 (Monocryl) supplementation on the biocom- Granderath is not that bad. What I would like to
patibility of a polypropylene mesh for hernia repair. Her- avoid is that the indication for mesh implantation
nia 2005 Oct; 9(3):212–7
comes nowadays to the situation that you implant
32. Hergueta-Delgado P, Marin-Moreno M, Morales-Conde S,
Reina-Serrano S, Jurado-Castillo C, Pellicer-Bautista F, Her- a mesh in every case. I do not think that is nec-
rerias-Gutierrez JM. Transmural migration of a prosthetic essary. I totally agree that we have problems in
mesh after surgery of a paraesophageal hiatal hernia. dealing with these huge hiatal hernias, and for this
Gastrointest Endosc 2006 Jul; 64(1):120 indication a mesh is probably necessary.
33. Klinge U, Klosterhalfen B, Muller M, Schumpelick V. For-
Matthews: We actually have a clinical trial going
eign body reaction to meshes used for the repair of ab-
dominal wall hernias. Eur J Surg 1999 Jul; 165(7):665–73 on right now with patients with type 1 hernias
34. Klinge U, Klosterhalfen B, Muller M, Ottinger AP, Schumpe- and type 3 hernias and in which we performed a
lick V. Shrinking of polypropylene mesh in vivo: an experi- biopsy of endoabdominal fascia. What we found
mental study in dogs. Eur J Surg 1998 Dec; 164(12):965–9 was that these patients have tissue abnormalities
35. Klinge U, Klosterhalfen B, Conze J, Limberg W, Obolenski
that are different even between the type 1 and
B, Ottinger AP, Schumpelick V. Modified mesh for hernia
repair that is adapted to the physiology of the abdominal
type 3 hernias, and so we are trying to understand
wall. Eur J Surg 1998 Dec; 164(12):951–60 more about the basics. Probably in the future we
36. Aly A, Munt J, Jamieson GG, Ludemann R, Devitt PG, will be able to selectively use a mesh, as in inguinal
Watson DI. Laparoscopic repair of large hiatal hernias. Br J hernia.
Surg 2005 May; 92(5):648–53
Jansen: When I look at the literature, it is very
37. Andujar JJ, Papasavas PK, Birdas T, Robke J, Raftopoulos Y,
Gagne DJ, Caushaj PF, Landreneau RJ, Keenan RJ. Laparo-
interesting that people dealing with hiatal hernia
scopic repair of large paraesophageal hernia is associated have never read the huge [amount of] literature
with a low incidence of recurrence and reoperation. Surg based on pathophysiological aspects of incisional
Endosc 2004 Mar; 18(3):444–7 hernia. There are so many questions not answered
428 Chapter 54 · Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty

in this area concerning everything we discussed. probably 80–90% of normal hiatal hernias can
Everyone tries a new shape of mesh or places be treated without a mesh with a primary suture.
meshes which were intended for incisional hernia And there are 5–10%, large or paraesophageal
for a long time. We have to think about the basics. hernias, which need a mesh. If you take this figure
What is the anatomy, the physiology? We need as the tailored approach, yes, probably we have to
good experimental results before placing a mesh in propagate it. But we probably do not need three
every hiatal hernia. to five different meshes for three to five different
Schippers: On Wednesday we had a lot of discus- indications.
sion concerning animal models, looking for the Schüssler: I am the gynecologist in this room, and
influence of meshes on the cord. And at that time I am the least to give answers, but what I’d like to
we were wondering whether the rat model is the ask you is, we have these small babies with large
appropriate animal. Maybe you would have had diaphragmatic hernias being easily repaired by the
fewer reactions to the mesh if you would have had pediatric surgeons without mesh materials. Is there
bigger animals? anything to learn from them? Just an ignorant
Jansen: Yes, probably. question. Maybe they can help a little bit.
Klinge: In this area, can it be a good indication to Jansen: I think it is a different situation. Dia-
use biologicals? phragmatic hernia cannot be compared to hiatal
Jansen: Perhaps. hernias.
Klinge: Is there any information from the litera- Kukleta: Just one more question. Do you think
ture? large paraesophageal hernias, type 3, are for every
Jansen: I do not know any. Probably there is some general surgeon?
clinical work on it. What you cannot find is any Jansen: No.
experimental work on biologics at the hiatus. Most
of the studies are clinical and not basic scientific
work.
Chowbey: Repairing hiatal hernia, there is one
point we are not considering seriously: The food
bolus is coming from the esophagus, and it needs
its space to go down to the stomach. Also, we have
to keep in mind that there will be a certain amount
of stasis in the lower part of the esophagus. If we
keep these two points in mind, probably our repair
54 will be better.
Schumpelick: I would like to hear from the audi-
ence. Who is using a mesh in second-size hiatal
hernias? ... Just three. And who never uses a mesh?
… It is the majority.
Chowbey: We have to look at the literature. As
we moved on from suture to prosthetic repair in
incisional hernia, there is the same trend in hiatal
hernia.
Gryska: The question I ask you is about the tai-
lored approach. I fear that the average surgeon
doing hiatal hernia surgery does not think as much
as we do. Do you believe the tailored approach can
be translated to general surgeons?
Jansen: The question is, what is the definition
of the tailored approach? I think in most cases,
55

Complications After Gastric


Banding–Results in Germany
C. Stroh and T. Manger
430 Chapter 55 · Complications After Gastric Banding–Results in Germany

Introduction
⊡ Table 55.1. Incidence of gastric banding worldwide [8]

Worldwide, approximately 1.7 billion people are Patients Countries


overweight or obese [16, 23, 63]. Morbid obesity
Roux-en-Y gastric bypass 65.11% 88%
is associated with numerous comorbidities such as
diabetes, hypertension, cardiac diseases, sleep ap- Gastric banding 24.41% 95%
noea syndrome, and degenerative skeletal diseases. Vertical banded gastroplasty 5.43% 79%
Every year, about 2.5 million obese people die from
Biliopancreatic diversion or 4.85% 67%
their comorbidities [62]. The costs of these comor-
duodenal switch
bidities are estimated to exceed $117 billion per
year in the United States [9].
In the international comparison, the Federal
Republic of Germany is one of the countries with a have compared low-pressure and high-pressure
very high prevalence of obesity. For this condition, bands. Reports in the literature on complication
gastric banding is the most frequently performed rates come only from single centres. The patient’s
bariatric operation in Europe [3, 4, 30]. Complica- outcome after gastric banding is influenced by the
tions such as slippage, pouch dilatation, and band long-term complications: slippage, pouch dilata-
disconnection can be treated by repositioning the tion, band migration, and port-site complications.
band or by performing a bypass in the case of its
failure, but band erosion always requires band
removal. Slippage and Pouch Dilatation
Neither the impact of the selected surgical
procedure on perioperative morbidity, weight loss, The incidence of slippage has decreased since
and degree of decrease in comorbidities nor the the introduction of the »pars flaccida« technique
profile of long-term complications have yet been (⊡ Figs. 55.1 and 55.2) [58]. Pouch dilatation is a
investigated in prospective studies. Therefore, ex- long-term complication after gastric banding. Its
periences with postoperative complications are incidence is influenced by the surgical approach
presented with an emphasis on the necessity of (open vs. laparoscopic) and the technique (peri-
quality assurance in the surgical treatment of mor- gastric vs. pars flaccida). Opening the lesser sac
bid obesity in Germany. during open band placement leads to a higher in-
cidence of pouch dilatation than the laparoscopic
approach does, with the creation of a small retro-
Discussion gastric channel. Data in the literature on the inci-
dence of pouch dilatation are very heterogeneous
After Roux-en-Y gastric bypass, gastric banding because most studies include different approaches
55 is the most frequently performed bariatric opera- and techniques. Many reports have a follow-up of
tion worldwide. According to data compiled from less than 5 years (⊡ Table 55.2).
meta-analysis, it is carried out in 95% of countries
performing bariatric surgery (⊡ Table 55.1) [8].
Meta-analysis reports the amelioration of co- Band Migration
morbidities such as diabetes, hypertension, hyper-
lipidaemia, and sleep apnoea without any recom- Intragastric band migration is characterised by a
mendations regarding long-term complications. In »silent« migration of the band into the stomach
the literature, only a few prospective randomised (⊡ Figs. 55.3 and 55.4) [57, 60]. Peritonitis symp-
studies have been reported. These studies compare toms are usually absent. Only very limited retro-
gastric banding with other bariatric procedures, spective data obtained from long-term studies are
especially with Roux-en-Y gastric bypass and available [8, 10, 34, 53, 64]. The incidence of band
sleeve gastrectomy. Otherwise, randomised trials migration ranges from 0.6% to 11% according to
Chapter 55 · Complications After Gastric Banding–Results in Germany
431 55

⊡ Fig. 55.1. Slippage ⊡ Fig. 55.2. Slippage

⊡ Table 55.2. Literature review on pouch dilatation (BMI body mass index; PG perigastric; PF pars flaccida)

First author Year Technique n BMI (kg/m²) Pouch dilatation Maximum follow-
rate (%) up (months)

Forsell [19] 1999 PG 326 Unknown 0.6 78

Doldi [17] 2000 PG 172 46.3 5.8

Szould [53] 2002 PF 715 43.1 7.40 30

Steffen [43] 2003 PF 824 42.2 2.70 60

Celen [13] 2003 PG 625 40 5.6

Zinzindohoue [65] 2003 PG/PF 500 44.3 8.00

Weiner [59] 2003 PF 984 46.8 >3.7 99

Angrisani [4] 2004 PF 3,562 43.3 4.1 60 (16.1%)

Chevallier [11] 2004 PF 1,000 44.3 10.4 72

Martikainen [27] 2004 PG/PF 123 49 21.0 108

Ren [37] 2004 PF 445 49.6 3.1 18

Silecchia [41] 2004 PF 313 46.1 3.2 Unknown

Zehetner [64] 2004 PF 190 Unknown 2.60 72

Spivak [42] 2005 PF 500 45.2 9.6

Stroh [46] 2005 PG/PF 3,973 Unknown 7.3 120

Stroh [45] 2005 PG/PF 168 49.6 10.70 120

Michelotto [29] 2006 PG/PF 684 42.2 6.1 60

Schouten [39] 2006 PG/PF 177 44.6 10.7 94

Suter [52] 2006 PG/PF 317 43.5 6.3 96

Balsiger [6] 2007 PF 196 44 12.2 108

Faretti [18] 2007 PG/PF 1,791 46.2 3.9 147


432 Chapter 55 · Complications After Gastric Banding–Results in Germany

the literature [11, 28, 33, 40] (⊡ Table 55.3). In a The data show an erosion rate of 60% in cases
few studies, band migration has been considered of intraoperative gastric perforation versus 3%.
a complication of the first 2 postoperative years, In our data, patients with a noncritical intake
caused by intraoperative gastric perforation [12, of nonsteroidal antirheumatic agents, bronchos-
13, 18, 24, 29, 55]. pasmolytic drugs, and anticoagulant substances
showed a higher incidence of band migration. In
53.3% of cases with intragastric band migration,
the patients had been treated with nonsteroidal
antirheumatic substances (26.6%), anticoagulant
substances (20.0%), or bronchospasmolytic agents
(0.6%). That is why, in our opinion, these medica-
tions should be considered a further cause of band
migration. Simultaneous cholecystectomy did not
significantly increase the erosion risk in our study.
Chronic inflammation at the tissue area cov-
ered by the band could be a further reason for
the development of erosion [1]. For example, in
our experience band migration occurs by 30–86
months postoperatively. Interestingly, the erosion
rate increased with long-term follow-up [44, 46,
48–50, 52].
Band erosion can lead to a life-threatening
condition in cases of upper gastrointestinal bleed-
ing and bowel obstruction [15, 54]. Therefore, cor-
rect diagnosis is essential. In our study we did not
seen any port infection in the first 3 months after
⊡ Fig. 55.3. Band migration operation and after band filling. In the literature,
port infection has been reported to be the first
symptom of erosion [25, 44]. However, our own
data reveal varying intervals between the onset of
port infection and the occurrence of erosion.
The treatment depends on symptomatology
(⊡ Fig. 55.5) [41]. We favour band removal in cases
of complete erosion, using gastroscopy and the
AMI Band Cutter (CJ Medical, Buckinghamshire,
55 UK) [57]. Gastroscopy is recommended at several
time points to recognise complete erosion; we pre-
fer intervals of 8 weeks. In the literature, 4-month
intervals have been reported [41]; such intervals
require patient reporting of information on possi-
ble complications as well as an acceptable distance
between the patient’s residence and the hospital.
Laparoscopy with intraoperative gastroscopy
using the AMI Band Cutter is a safe method of
band removal. A lesion of the gastric wall can be
sutured, and a drain can be placed. In patients
with bleeding of the upper gastrointestinal tract
⊡ Fig. 55.4. Band migration or abscess, the band has to be removed via lapa-
Chapter 55 · Complications After Gastric Banding–Results in Germany
433 55

⊡ Table 55.3. Literature review on incidence of band migration (BMI body mass index; OP operation; PG perigastric; O open;
L laparoscopic; SAGB Swedish Adjustable Gastric Bands; PF pars flaccida; HG Heliogast band)

First author Year n BMI Rate OP OP Type Follow-up Maximum


(%) rate (%) follow-up
(months)
Forsell [19] 1999 326 4.6 PG SAGB 97 78
Meir [28] 1999 122 1.6 O/L PG Lap-Band 88 60
Miller [30] 1999 158 43 0.6 L PG SAGB 98 46
DeJonge [15] 2000 91 44.7 3.3 L PG Lap-Band 100 24
Doldi [17] 2000 172 46.3 0.6 O/L PG Lap-Band 99.4 72
Weiss [57] 2000 211 1.9 L PG Lap-Band 33
Baldinger [5] 2001 714 1.0 L PG SAGB
Holeczy [22] 2001 36 45.6 0 L PG Lap-Band 24
Silecchia [40] 2001 148 44.2 7.5 L PG Lap-Band 831 54
Niville [34] 2001 301 42.5 1.66 L PG Lap-Band 984 73
Belachew [7] 2002 763 42 0.9 L PG Lap-Band 90 66
Gustavsson [21] 2002 90 43 14.4 O PG SAGB
Szold [53] 2002 715 43.1 0.5 30
Wolff [61] 2002 256 47 0.8 PG/PF Unknown 48
Steffen [43] 2003 824 42.2 1.6 L PF SAGB 97 60
Coskun [14] 2003 70 45.2 2.8 O/L Lap-Band 39
Vertuyen [56] 2003 727 45 1.4 PG Lap-Band Unknown
Weiner [59] 2003 984 46.8 0.3 L PG/PF Lap, HG, SAGB 972 99
Angrissani [4] 2004 3,562 43.4 2.1 L PG/PF 161 60
Chapman [10] 2004 8,504 0.6 Unknown
Chevallier [11] 2004 1,000 44.3 0.30 L Lap-Band 72
Martikainen [27] 2004 123 49.0 9.00 108
Mittermair [31] 2004 682 0.8 L PF SAGB 48
Silecchia [41] 2004 313 46.1 5.1 L PG/PF Lap-Band 90
Ren [37] 2004 445 49.6 0.2 L PF Lap-Band 18
Zehetner [64] 2004 190 Unknown 2.1 72
Abu-Abeid [2] 2005 754 2.1 L PF Lap-Band 40
Nocca [35] 2005 4,236 43.2 1.6 L PG/PF All
Stroh [46] 2005 3,973 1.0 O/L PF/PG All 120
Stroh [45] 2005 168 49.6 4.2 O/L PG/PF Lap-Band 120
Michelotto [19] 2006 684 42.2 1.1 O/L PG/PF Unknown 60
Suter [52] 2006 317 43.5 9.5 L PG/PF Lap/SAGB 81.5 96
Lattuada [26] 2007 571 42.9 0.52 L PG/PF Lap, HG, SAGB 100
Balsiger [6] 2007 196 44 1.5 L PF SAGB 108
Favretti [18] 2007 1791 46.2 0.9 L PG/PF Lap-Band 145
434 Chapter 55 · Complications After Gastric Banding–Results in Germany

Symptoms

Nonspecific symptoms Port Bleeding Intraabdominal


Vomiting infection Bowel obstruction abscesses

Contrast swallow Abdominal ultrasound


Gastroscopy Computed tomography
Abdominal ultrasound to exclude intraabdominal

Removal of the port system

Band removal via gastroscopy Laparoscopic band removal Open band


using AMI Band Cutter (CJ and intraoperative gastroscopy removal
Medical, Buckinghamshire, UK) using AMI Band Cutter
after complete band migration

⊡ Fig. 55.5. Differentiated treatment of gastric band migration [44]

rotomy if laparoscopy fails. Tangential resection of performed in one surgical intervention have been
the gastric wall can become necessary in cases of described in the literature [2]. Because of the dif-
massive bleeding. ferent causes of band erosion and the significantly
In the literature, a correlation of the erosion higher migration rate following intraoperative gas-
rate to the band type (high-pressure vs. low-pres- tric perforation, and based on the currently avail-
sure band) has not been described [20, 21, 54]. The able data, band removal in cases of erosion with
data presented here show that the erosion rate of simultaneous rebanding should not be performed
the LAP-Band (Inamed Health, Santa Barbara, CA, since there is a potential risk of infection of the
55 USA) is higher than that of the Gastrobelt (MED- new band. In addition, because of the high failure
ING, Germany) or Swedish Adjustable Gastric rate after band revision, a conversion to Roux-
Bands (SAGB; Obtech, Ethicon Endo-Surgery), en-Y gastric bypass or biliopancreatic diversion
but SAGB have been used only for the last 2 years. needs to be considered [31].
At the end of the 1990s, repositioning of the Since January 1, 2005, data collected in the
band in cases of slippage and pouch dilatation was German multicentre observational study for qual-
widely performed, but the data from our study– ity assurance in obesity surgery for all bariatric
with a higher incidence of gastric band migra- interventions and revisions have been available
tion–as well as the data in the literature show dis- online for assessing the surgical treatment of mor-
appointing results [44, 45, 48]. That is why, in bid obesity [47]. Although patients are selected
accordance with the literature [52], we see no according to the guidelines of the International
indication for rebanding in cases of slippage or Federation for the Surgery of Obesity, the Eu-
pouch dilatation. Band removal and rebanding ropean Association for Endoscopic Surgery, and
Chapter 55 · Complications After Gastric Banding–Results in Germany
435 55
the German Society for Surgery of Obesity [38], well described [41, 50, 52]. Through long-term
substantial differences are encountered when com- follow-up, researchers need to investigate whether
paring centres of bariatric surgery because of the the advantages of the low-pressure bands also re-
regionally varying incidences of morbid obesity sult in a decreased erosion rate. In addition, the
and the house policies of the different surgical de- relevance of band manometry should be investi-
partments. For instance, age and body mass index gated in studies [44]. Patient-related factors such
(BMI) of the surgically treated patients are sig- as the intake of nonsteroidal anti-inflammatory
nificantly higher in Germany compared with data drugs, bronchospasmolytic drugs, and anticoagu-
obtained in the meta-analysis on bariatric surgery lant substances must be included in data analy-
[8]. In addition, significantly more patients suffer sis and further studies. Band migration should
from type II diabetes mellitus and arterial hyper- be treated according to symptomatology and the
tension. patient’s specific condition. In our opinion, the
The possible consequence of a higher comor- higher incidence of band migration after intraop-
bidity rate is severe metabolic syndrome. The im- erative gastric perforation is a contraindication to
pact of a high(er) preoperative BMI on weight replacing a new gastric band after band removal
reduction needs to be investigated through a long- because of erosion [34]. In this case, conversion to
term study. Data obtained in the German multi- either Roux-en-Y gastric bypass or biliopancreatic
centre observational study for quality assurance diversion is recommended [32].
in obesity surgery also confirm the worldwide Furthermore, there are no data in the litera-
tendency towards combined and malabsorptive in- ture on specific criteria that would allow us to
terventions to reduce both body weight and the select patients, either for restrictive or malabsorp-
frequency of comorbidities. This effect is under- tive procedures, to improve final outcomes. To
scored by the very high BMI of German patients. guarantee long-term success after bariatric surgery
According to the literature, the reintervention rate and to avoid complications, particularly following
per year of follow-up after a stomach volume op- combined procedures, lifelong postoperative care
eration is between 3% and 4% [6, 52]. Prospective is required; this is a specific peculiarity of obesity
long-term trials are necessary to detect short-term surgery. Because only low-level evidence is avail-
and long-term complications after different bariat- able, based on limited long-term follow-up data
ric procedures. The amelioration of comorbidities obtained in a few single-centre studies, prospective
should not be a single point of the studies because research enrolling all patients is indicated. This is
the complication rate after bariatric surgery seems being done by the German multicenter observa-
to be higher than that reported in the literature. tional study for quality assurance in obesity sur-
Predictive factors for patients’ election for differ- gery. In this study, weight reduction, amelioration
ent procedures should be evaluated to reduce the of comorbidities, and long-term complications are
complication and reoperation rates. registered annually as parameters that assess daily
practice in the surgical treatment of morbid obe-
sity in Germany [44].
Conclusion

There are varying symptoms of band erosion. References


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Chapter 55 · Complications After Gastric Banding–Results in Germany
437 55
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results. Obes Surg 2001; 11:507–12
438 Chapter 55 · Complications After Gastric Banding–Results in Germany

Discussion we just started a register, and we hopefully will


have some answers in a few years.
Gryska: Having a look at a reoperation rate of Schumpelick: Thank you very much for the com-
30%, do you think we should look at gastric band- ment.
ing as something we should do or should not do Klinge: Are there any analyses using Kaplan–Meier
anymore? curves showing the cumulative incidence rates of
Stroh: That is a big discussion. In Europe, the situ- complications? The reason is that, as in incisional
ation is that the rate of gastric banding performed hernia, we know that the means given in the lit-
is decreasing more and more. And malabsorptive erature have to at least be doubled over the long
procedures are increasing. But in the States, it is term.
quite different at the moment, because after the Schumpelick: You presented the data to the Ger-
FDA approval, bandings are performed more and man Surgical Society. What was the reaction?
more. But you should be careful having a look at Stroh: Moving away from the band.
the European data.
Franz: You are right. In my hospital I am required
to report every explantation and the reason why
I do so. This is a medical–legal protection for the
hospital. Are you required in Germany to report
explantations to somebody?
Stroh: No. That is a very big problem in Germany.
And a very big problem for the insurance system
as well.
Franz: Bruce. Do you have to report?
Ramshaw: Not at this point. The biggest question
is, who is going to fund this collection?
Chowbey: What approach do you use for place-
ment of the band?
Stroh: We are using the pars flaccida technique.
Chowbey: But most of the studies you showed
used the perigastric approach.
Stroh: This is why it is really difficult to show if
this complication is really increasing or just a com-
plication of an approach which nobody uses any-
more. We know that slippage is decreasing, and we
know that pouch dilatation is decreasing, but we
55 really do not know if migrating is really decreas-
ing. So we have used the pars flaccida technique
since 2000, and band migration is occurring after
10 years. So we really do not know today if this
complication is really decreasing as well.
Chowbey: In India we are moving away from the
band because we saw that 25–35% of the patients
need further operations or explantation of the
band.
Bringman: I work in Stockholm, where gastric
banding was invented, and we almost stopped us-
ing it due to its complications. Another comment
is that concerning registration of obesity surgery,
56

Alloplastic Implants for the Treatment


of Stress Urinary Incontinence
and Pelvic Organ Prolapse
T. Kavvadias, U. Klinge, B. Schuessler
440 Chapter 56 · Alloplastic Implants for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Introduction and POP) with special emphasis on the advantages


and unresolved issues.
Stress urinary incontinence (SUI) is the complaint
of involuntary leakage with effort or exertion or
with sneezing or coughing [1]. Urethral hyper- Meshes in Stress Urinary Incontinence
mobility, which permits urethral opening during
stress, as well as insufficiency of the urethral Abdominal colposuspension was the procedure of
sphincter seem to be the two main contributing choice for surgical management of SUI until 1995,
factors that lead to the above mentioned symp- when Ulmsten and Petros introduced the intra-
toms [2]. Pelvic organ prolapse (POP)–which is vaginal slingplasty using polypropylene mesh, a
defined as protrusion of the anterior vaginal wall, procedure that was received with great enthusiasm
the vaginal cuff, and the posterior vaginal wall, because of its simplicity and short operating time
thus including the bladder, enterocele, or rectum– [7]. In a controlled randomized trial, this proce-
often shows a strong correlation with lower uri- dure was shown to have no inferiority in terms of
nary tract symptoms in women [3]. Apart from efficacy as well as in the long term. Success rates
the objective findings, symptoms of POP are reach 81%. Furthermore, it is advantageous in
heaviness, a dragging sensation, and the need to terms of fewer postoperative complications and
digitally replace the prolapse in order to defecate less recovery time compared with colposuspension
or micturate [1]. POP development is multifacto- [8]. However, although well manageable, bladder
rial; vaginal childbirth, advancing age, and in- injury caused by insertion of the trocar is more
creased body mass index seem to be the most common when using the sling procedure [9].
consistent risk factors [4]. At present, the gold standard in SUI surgery
The measured prevalence of urinary inconti- is the suburethral sling, using either the tension-
nence varies widely among different populations free vaginal tape (TVT) or the transobturator tape
and age groups and is very sensitive to how the (TOT) technique (⊡ Fig. 56.1). The two procedures
survey was conducted and whether urodynamics do not seem to differ in terms of efficacy, with
were performed. Reports of »any« incontinence or TOT being advantageous because of the lower rate
»at least once in the past 12 months« are estimated of bladder injuries [10].
to apply to 25–45% of adult women, and SUI has The initial concern that the meshes used might
a percentage of 50% [5]. The prevalence of POP lead to high rates of erosion did not hold true
seems to be around 29% of the female population, when macroporous polypropylene was used. In
according to the presence of symptoms [6]. two long-term trials, the erosion rate was 1.7% and
Apart from the obvious high prevalence of SUI 3.1%, respectively. Most of the erosion was into the
and POP, they both have a significant impact on vagina [9, 11], whereas erosion into the urethra or
a woman’s quality of life [2]. The symptoms affect bladder was more or less anecdotal [12].
a woman’s everyday life in many ways, including However, low erosion rates in SUI depend on
decreased physical and sexual activity, diminished the selection of material. A prospective random-
56 social and self-confidence, and low overall quality ized controlled trial by Meschia et al. showed
of life and sense of well-being. that vaginal erosion of the Amid type III mesh
Today, surgery is the most promising and ef- used for intravaginal slingplasty was as high as
fective therapy for both SUI and POP, showing 9% in a 2-year follow-up, which is significantly
high rates of subjective and objective cure and higher compared to 0% using the classical TVT
strong improvement in terms of quality of life. (type I macroporous, monofilament, polypropyl-
Lately there is an ongoing tendency to use meshes ene mesh) in the same trial [13]. This was sup-
in the surgical treatment of SUI and POP, with ported by Baessler et al., who showed a series of
the development of the »perfect« material and major complications, including erosion of this type
technique being in focus. This chapter presents an of mesh, in a case series of 19 women treated with
overview of mesh surgery in urogynecology (SUI intravaginal slingplasty [14].
Chapter 56 · Alloplastic Implants for the Treatment of Stress Urinary Incontinence
441 56
The use of silicone also seems to increase ero-
sive complications. Kuschel et al. demonstrated
dislocation of the silicone column of the TOT-Sa-
fyre, a composite sling consisting of a macroporous
polypropylene mesh beneath the urethra and two
silicone arms anchoring the sling. The erosion rate
reached a percentage of 8.8%, mainly as a result of
dislocation of the silicone arm from its lateral posi-
tion beneath the vaginal mucosa (⊡ Fig. 56.2) [15].
With ongoing research and further develop-
ment of existing macroporous materials, incidents
such as the »rolling effect« of the suburethral
sling are more or less under control. However,
inflammatory reaction around the mesh cannot
⊡ Fig. 56.1. Routes for transobturator and retropubic slings
be avoided. Macrophage accumulation around the
filaments of the tape, cellular proliferation, and
changes in collagen composition are present in
the vaginal wall, identical to the reaction found
in the abdominal wall after hernia mesh surgery
(⊡ Fig. 56.3) [16].
Although erosion is not a major complication
all in all, development of the right material is still
an issue. Overall, the properties and requirements
of the sling material that might guarantee high
success rates combined with fewer complications
can be defined as follows: pore size >1 mm, little
elasticity (<10%), and width ≥1 cm to prevent cut-
ting through the urethra under load. The tensile
strength must not necessarily be >2 N/cm, and the
⊡ Fig. 56.2. Removal of an eroded transobturator Safyre sling tension by application should not exceed 3–5 kPa;
after dislocation of the right silicone arm under the vaginal
mucosa
this limitation could eventually be objectified by
future intraoperative measurements. The biologi-
cal properties of the mesh should guarantee mini-
mal inflammation and fibrosis with little white cell
turnover and little shrinkage. Sharp-ending fibers
must be avoided because they may stimulate the
inflammatory response. Nonabsorbable, perma-
nent, and synthetic materials should be preferred
instead of collagen devices [17].

Meshes in Pelvic Organ Prolapse

Besides conservative options such as vaginal pes-


saries and physiotherapy, surgery is the mainstay
of POP treatment. Surgery in prolapse is a three-
⊡ Fig. 56.3. Accumulation of macrophages around the fila- target issue: (1) control of prolapse, (2) control
ments of a polypropylene mesh (suburethral sling) or avoidance of problems related to bladder and
442 Chapter 56 · Alloplastic Implants for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

bowel function, and (3) restoration or improve- Hiltunen et al. (2008), in a randomized con-
ment of cohabitation, without new dyspareunia trolled trial that included 202 women and used
either for the female patient or her male partner. the Sofradim mesh, reported an erosion rate of
Basically, there are two different approaches: 17% and a recurrence rate of 6.7% in a 12-month
(1) transvaginal fixation of the vaginal cuff without follow-up [19]. Collinet et al. [20] and Abdel-
mesh and (2) abdominal cuff fixation with mesh, Fattah et al. [21] reported high erosion rates of
which is necessary to bridge the vaginal cuff for 12.2% and 10%, respectively, using the Prolift
fixation at the hollow of the sacrum. mesh. Altman et al., using the same material and
In a Cochrane review, Maher et al. compared a follow-up time of 2 months, reported an ero-
the surgical routes used in pelvic surgery. They sion rate of 1.6% but a higher recurrence rate of
found that the vaginal approach offers less surgery 13% [22]. In the same study, pelvic pain was up to
time, a quicker return to activities, and lower costs; 5.2%. Many of the studies have not yet reported
the abdominal approach showed lower recurrence on dyspareunia, although in an observational
rates and less dyspareunia, at the expense of a study of Tayrac et al., this problem reached a per-
mean erosion rate of 3.2% [18]. centage of 12.8% [23].
Therefore, vaginal mesh techniques might be
able to combine the advantages of both procedures:
less surgery time, a quicker return to activities, and Unresolved Issues and Prevention
lower costs from the traditional vaginal approach Strategies
and low recurrence and dyspareunia rates from
the abdominal route. Based on this, numerous In summary, there are three different problems
vaginal self-anchoring mesh »kits« have been in- related to the mesh kits in use today: erosion,
troduced, all using lightweight macroporous mesh. pain, and dyspareunia, and all three result from
The results today are derived primarily from the the implanted mesh. As far as erosion is con-
Apogee and Perigee systems as well as the Prolift cerned, the fact that the same material used in
system. Surprisingly, the results in terms of mesh the abdominal approach shows better results in-
erosion (⊡ Fig. 56.4), dyspareunia, and pain so far dicates that it is not just the material that causes
do not meet the expectations of many experts in mesh complications but, apparently, the route
this field. of application. This is substantiated by previous
data from Wu et al., who showed that the erosion
rate for abdominal sacrocolpofixation increases
when the mesh is introduced through the va-
gina [24]. Furthermore, this is supported by an
analysis of results and changes in surgical strategy
by Collinet et al., who showed that minimiz-
ing vaginal incision may lead to a reduction in
erosion [20].
56 Another unresolved issue is that of the mesh
as a pain initiator, particularly pain in the muscles
adjacent to the sacrum. One possible cause could
be the anchoring of the mesh in the pelvic muscles.
One solution might be to replace nonabsorbable
anchoring arms with absorbable material.
Dyspareunia is based on erosion (especially
if the partner has the problem) as well as mesh
shrinkage and the muscle pain caused by the an-
choring arms. Recent guidelines recommending
⊡ Fig. 56.4. Mesh erosion on the anterior vaginal wall avoidance of vaginal mesh kits in sexually active
Chapter 56 · Alloplastic Implants for the Treatment of Stress Urinary Incontinence
443 56
women do not seem to be a valid solution, as this 12. Werner M, Najjari L, Schuessler B. Transurethral resection
would exclude the majority of patients [25]. of tension-free vaginal tape penetrating the urethra. Obs-
tet Gynecol 2003;102(5 Pt 1):1034–6
In essence, because the rationale for the use of
13. Meschia M, Pifaroti P, Bernasconi F, Magatti F, Vigano
mesh kits is intact, further developments in mesh R, Bertozzi R, Barbacini P. Tension free vaginal tape and
and anchoring material are needed, as well as a intravaginal slingplasty for stress urinary incontinence: a
better understanding of the vaginal wall reaction multicenter randomised trial. Am J Obstet Gynecol 2007;
to polypropylene meshes, especially regarding why 195(5):1338–42
14. Baessler K, Hewson A, Tunn R, Schuessler B, Maher C.
a small mesh surface, as used in TVT/TOT, shows Severe mesh complications following intravaginal sling-
a behavior different from that of large surfaces of plasty. Obstet Gynecol 2005;106(4):713–6
the same material. 15. Kuschel S, Schuessler B. Results on function and safety
of the Safyre-t, a hybrid transobturator vaginal sling for
the treatment of stress urinary incontinence. Neurourol
Urodyn 2008;27(5):403–6
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incontinence. Scand J Urol Nephrol 1995;29(1):75–82 BJOG 2008;115(1):22–30
8. Ward K, Hilton P; UK and Ireland TVT Trial Group. Tensi- 22. Altman D, Vayrynen T, Engh M, Axelsen S, Falconer C,
on-free vaginal tape versus colposuspension for primary Nordic Transvaginal Mesh Group. Short-term outcome
urodynamic stress incontinence: 5-year follow up. BJOG after transvaginal mesh repair of pelvic organ prolapse.
2008;115(2):226–33 Int Urogynecol J Pelvic Floor Dysfunct 2008;19(6):787–93
9. Ward K, Hilton P; UK and Ireland TVT Trial Group. Prospec- 23. de Tayrac, Devoldere G, Renaudie J, Villard P, Guilbaud O,
tive multicenter randomised trial of tension-free vaginal Eglin G, French Ugytex Study Group. Prolapse repair by
tape and colposuspension as primary treatment for stress vaginal route using a new protected low-weight polypro-
incontinence. BMJ 2002;325(7355):67 pylene mesh: 1 year functional and anatomical outcome
10. Freeman R, Holmes D, Smith P, Hillard T, Yang Q, Agur in a prospective multicentre study. Int Urogynecol J Pelvic
W, Abrams P. Is transobturator tape (TOT) as effective Floor Dysfunct 2007;18(3):251–6
as tension-free vaginal tape (TVT) in the treatment of 24. Wu J, Wells E, Hundley A, Connolly A, Williams K, Visco A.
women with urodymamic stress urinary incontinence? Mesh erosion in abdominal sacral colpopexy with and
Results of a multicentric RTC [ICS abstract]. Neurourol without concomitant hysterectomy. Am J Obstet Gynecol
Urodyn 2008;27(7):573–4 2006;194(5):1418–22
11. Kuuva N, Nilsson C. Long-term results of the tension-free 25. Konsensuspapier der Operateure der Prolift-Trainingszen-
vaginal tape operation in an unselected group of 129 tren. Empfehlungen zur Rekonstruktion von Beckenbo-
stress incontinent women. Acta Obstet Gynecol Scand dendefekten mit Prolift. Gynaekologie Aktuell; Ein Sup-
2006;85(4):482–7 plement zum Frauenarzt, April 2008
444 Chapter 56 · Alloplastic Implants for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Discussion Schüssler: That may happen with the TVT. But we


do not have many problems with the TVT. On the
Kukleta: Well, I was wondering when the TVT was other hand, if you do overtension, then the patient
coming up so that you do not have more infec- immediately has problems.
tions. Because we would probably never implant a
mesh under conditions as you do.
Schüssler: We also wonder about that. But infec-
tion is not a problem at all.
Fitzgibbons: You said that the infection rate is
very low but erosions are high. In our way of
thinking about prosthetic material, it is the same.
But my comment is that this area is probably
ideal for the biologicals if they can be put under
tension.
Schüssler: There are data out in the literature
with biological materials for both prolapse and
incontinence. But the results are not as good as we
expected them [to be].
Klinge: I was always fascinated about the similar
problems they have in the pelvic area that we
have for our normal hernias. And a lot of the
experiences we had, you had as well. Some years
ago they tried PTFE as a band, and it failed com-
pletely. And they tried small porous meshes and
had a high complication rate. So they changed
to the large porous meshes. They tried biologi-
cals and had the same problems. So there is the
problem that we have, and if we look to the last
talks here, the hiatal hernia, the gastric banding,
and this one. The common problem of all of them
is migration. Migration through tissue. And we
all know the problem. In all of these diseases, we
have the serious problem that if the prosthesis
shows some kind of migration, we have serious
problems. And therefore we have to look at what
is the reason for migration on the cellular level
and whether there any ideas for devices that have
56 a higher or lower risk of migrating through tissue.
So we should work together because we have the
same problems.
Schumpelick: But I think there are slight differ-
ences. Because we do it absolutely aseptically, and
they do it with physiologic contamination.
Kukleta: I know that you do not think about the
tension you put on. You just pull it out and cut it
off, and just the structure of polypropylene allows
it to stay in place. Do you think you induce local
ischemia by pressure?
57

Prophylactic IPOM Mesh To Prevent


Parastomal Hernias
D. Berger and M. Bientzle
446 Chapter 57 · Prophylactic IPOM Mesh To Prevent Parastomal Hernias

Introduction
⊡ Table 57.1. Demographic and surgical data

After an ostomy is created, hernias are a common  14 female, 19 male patients


complication [1, 2]. Sometimes the frequency  Median age: 71 years (41–86)
 Median body mass index: 27 (17–37)
exceeds 50% after 1 year, especially if computed
 Median operating time: 153 min (90–260)
tomography (CT) is used diagnostically [3]. The  19 APRE, 12 Hartmann’s procedures (including two
parastomal hernia may be associated with stoma colectomies), two patients with only correction of a
care problems and so considerably limits the preexisting stoma
social activity of the affected patient. The cor-  30 colostomies, three ileostomies
 6/33 laparoscopic procedures
rect surgical technique when creating a stoma
 24/33 malignant diseases, 9/33 benign diseases
is inevitable, but surgical dogmas have not been  Median follow-up: 18 months (2–28)
unequivocally confirmed [1]. From a pathoge-
netic point of view, parastomal hernias may be
comparable with incisional hernias, explaining
the lacking efficacy of only technical approaches was necessary. The only exclusion criterion was
[4–7]. If disturbed collagen synthesis is accepted an emergency procedure. Major contamination
as the underlying problem, the use of synthetic did not occur during the primary procedure. De-
nonabsorbable meshes is mandatory for treating mographic and surgical data are summarized in
and preventing hernias. ⊡ Table 57.1.
From a technical point of view, prophylactic As also shown in ⊡ Table 57.1, the stomas were
meshes can be used in ways known from therapeu- predominantly created because of malignant dis-
tic procedures. An onlay, sublay, or intraperitoneal eases. One patient suffered from ulcerative colitis,
positioning of the prophylactic mesh may be pos- and two patients had Crohn’s disease. Other un-
sible. Advantages of the intraperitoneal onlay mesh derlying diseases were otherwise untreatable se-
(IPOM) technique are its technical convenience, its vere incontinence or problems with a preexisting
easy performance by laparoscopy, and the reduced stoma.
infection rate as shown for laparoscopic incisional DynaMesh IPST represents a real mesh struc-
hernia repair [8, 9]. ture warp-knitted by polyvinylidene fluoride
The availability of a mesh with a central hole (PVDF) containing a small amount of polypropyl-
and a dome made of a material allowing intraperi- ene on the parietal side. It has been experimentally
toneal use, DynaMesh IPST (FEG-Textiltechnik, proven that the mesh is well incorporated and
Aachen, Germany), was the precondition of a pro- effectively prevents adhesions to the intestine. Fur-
spective observational study to evaluate the rate thermore, PVDF is associated with a reduced in-
of parastomal hernias and other stoma-related or flammatory response and development of fibrotic
mesh-related complications when the mesh was tissue compared with polypropylene or expanded
prophylactically used in an intraperitoneal onlay polytetrafluoroethylene [10–12]. The implantation
position. technique is easy and does not significantly pro-
long the procedure.
In short, the stoma loop is pulled through
57 Patients, Material, and Methods the funnel, which is oriented to the abdominal
cavity. The funnel should fit tightly. Therefore, in
Between March 2006 and May 2008, 33 patients 32 cases, meshes with a funnel diameter of 2 cm
(14 female, 19 male) were enrolled and prospec- were used. One patient received a mesh with a
tively followed every 3 months. Thirty colostomies funnel diameter of 3 cm. The mesh is fixed only
and three ileostomies were created. Two of these by tacks at the edges and around the stoma itself.
patients underwent correction of a preexisting The stoma loop itself is not fixed at the mesh. Six
ileostomy or colostomy. In two patients with a of 33 procedures were performed laparoscopi-
preexisting stoma, a colectomy with a new stoma cally.
Chapter 57 · Prophylactic IPOM Mesh To Prevent Parastomal Hernias
447 57
Results complications are associated with parastomal her-
nia repair, thus strongly supporting the claim that
One patient with liver metastasis of an advanced parastomal hernias should be prevented.
carcinoma of the sigmoid died in the early post- In 2004 a randomized study demonstrated the
operative period because of hepatic failure. Two dramatically reduced incidence of parastomal her-
patients died after 6 and 15 months, respectively, nias after prophylactic mesh implantation in a
due to advanced cancer (n=1) and liver failure dur- retromuscular position [14, 15]. Since that time,
ing anti-inflammatory therapy of ulcerative colitis further studies have supported the view that pro-
(n=1). During a median follow-up of 18 months, phylactic use of a mesh may reduce the rate of
no parastomal hernia or stoma prolapse was de- parastomal herniation [16–19]. The meshes were
tected clinically. In 15 patients, a CT scan was per- implanted after being incised in a sublay or onlay
formed 1 year after the primary procedure, which position. In these series, the infection rate proved
also excluded any parastomal herniation. Stomal to be very low, and other complications were not
obstructions did not occur despite the fact that described. Therefore, a summary of all studies
in 32 out of 33 patients, a mesh with the smallest dealing with the prophylactic use of meshes to pre-
diameter (2 cm) was used. Even in a patient with vent parastomal herniation concluded that meshes
a body mass index of 38, the smallest diameter are effective and associated with a negligible over-
proved to be adequate without signs of obstruc- all complication rate [20]. However, these series
tion. Therefore, it should be pointed out that the had in common the fact that the number of en-
funnel should fit tightly around the bowel to pre- rolled patients was low, which could explain the
vent a prolapse. Meshes with larger diameters, low rate of complications.
3 cm and even 4 cm, are available, but these need In our study, the technique differed completely
to be reserved for very obese patients with a dra- from that used in the above-mentioned studies by
matically thickened mesocolon. the intraperitoneal application of the mesh. Prefer-
Primary mesh infections were not observed. ence for an IPOM technique is based on the fact
Two patients developed a secondary enteral leak that it is more suitable for laparoscopic approaches.
with peritonitis. Both patients were treated with Furthermore, the preparation of different abdomi-
daily planned relaparotomies and lavage. After the nal wall layers, creating large wound areas, is no
peritonitis had disappeared, the abdominal wall longer necessary. At least for laparoscopic repair of
was closed, leaving the mesh in situ. In both pa- incisional hernias, it has been clearly shown that the
tients the healing process proceeded uneventfully. infection rate is lower compared with conventional
After almost 2 years and 3 months, respectively, techniques, which is explained by the reduced tissue
there are no clinical signs, elevated blood cell trauma and the contact of the mesh with perito-
count, or elevated serum levels of C-reactive pro- neum on both sides [8, 9]. Another aspect favoring
tein in either patient. the intraperitoneal position is the possible overlap,
The time needed for implantation of the pro- which is much greater than in a sublay position.
phylactic mesh was very low, never exceeding Sometimes the retromuscular space is quite re-
5 min. stricted because of narrow rectus muscles. In these
cases, sometimes only 2 cm of overlap is possible.
The overlap of intraperitoneal positioning is limited
Discussion only by the anatomical borders of the abdominal
cavity. Therefore, a width of more than 5 cm is al-
As outlined above, parastomal hernia is a very ways possible, leading to wide augmentation of the
frequent and sometimes burdening problem for abdominal wall around the stoma.
the affected patients [1, 2]. Although the repair The shape of the mesh used in our study
of parastomal hernias seems to be effective today, provides further advantages compared with two-
the only technique that yields good results remains dimensional meshes that are incised. The cross-
difficult and elaborate [13]. Furthermore, some shaped incision is followed by a relevant impair-
448 Chapter 57 · Prophylactic IPOM Mesh To Prevent Parastomal Hernias

ment of the mesh stability. On the other hand, the 7. Kasperk R, Willis S, Klinge U, Schumpelick V (2002) Update
funnel around the stoma loop should effectively on incisional hernia. Parastomal hernia. Chirurg 73:895–898
8. Pierce RA, Spitler JA, Frisella MM, Matthews BD, Brunt
prevent any prolapse. The main precondition,
LM (2007) Pooled data analysis of laparoscopic vs. open
however, is the tight fitting of the funnel around ventral hernia repair: 14 years of patient data accrual. Surg
the stoma loop. However, a stenosis may also be Endosc 21:378–386
created if the funnel is too narrow. We did not ex- 9. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE (2008)
perience any stenosis, but we systematically tested Minimally invasive ventral herniorrhaphy: an analysis of
6,266 published cases. Hernia 12:9–22
the outlet digitally at the end of the procedure.
10. Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpe-
A further aspect sometimes raised is the risk lick V (2002) PVDF as a new polymer for the construction
of infection if the contaminated end of the stoma of surgical meshes. Biomaterials 23:3487–3493
loop is pulled through a mesh. In our series at 11. Conze J, Junge K, Wei BC, Anurov M, Oettinger A, Klinge U,
least, there was no primary infection, and the Schumpelick V (2008) New polymer for intra-abdominal
meshes–PVDF copolymer. J Biomed Mater Res B Appl
literature does not support that potential risk. On
Biomater 87(2):321–328
the contrary, the infection rate published today 12. Junge K, Binnebosel M, Rosch R, Jansen M, Kammer D,
is astonishingly low [20]. The described course Otto J, Schumpelick V, Klinge U (2009) Adhesion forma-
of two patients with severe septic complications tion of a polyvinylidenfluoride/polypropylene mesh for
clearly showed that the combination of the intrap- intra-abdominal placement in a rodent animal model.
Surg Endosc 23(2):327–333
eritoneal position and PVDF as the mesh material
13. Berger D, Bientzle M (2007) Laparoscopic repair of pa-
effectively reduces the susceptibility to persistent rastomal hernias: a single surgeon’s experience in 66
mesh infections. patients. Dis Colon Rectum 50:1668–1661
In conclusion, the prophylactic use of Dy- 14. Jänes A, Cengiz Y, Israelsson LA (2004) Randomized clini-
naMesh IPST to prevent parastomal hernias shows cal trial of the use of a prosthetic mesh to prevent paras-
tomal hernia. Br J Surg 91:280–282
promising results. No complications occurred dur-
15. Janes A, Cengiz Y, Israelsson LA (2004) Preventing paras-
ing a median follow-up of 18 months. In particular, tomal hernia with a prosthetic mesh. Arch Surg 139:1356-
infectious complications were not observed. The 1358
procedure can be easily performed laparoscopi- 16. Marimuthu K, Vijayasekar C, Ghosh D, Mathew G (2006)
cally as well as in conventional surgery for perma- Prevention of parastomal hernia using preperitoneal
mesh: a prospective observational study. Colorectal Dis
nent terminal colostomies and ileostomies.
8:672–675
17. Gogenur I, Mortensen J, Harvald T, Rosenberg J, Fischer A
(2006) Prevention of parastomal hernia by placement of a
References polypropylene mesh at the primary operation. Dis Colon
Rectum 49:1131–1135
1. Carne PW, Robertson GM, Frizelle FA (2003) Parastomal 18. Israelsson LA (2005) Preventing and treating parastomal
hernia. Br J Surg 90:784–793 hernia. World J Surg 29:1086–1089
2. Israelsson LA (2008) Parastomal hernias. Surg Clin North 19. Nagy A, Kovacs T, Bognar J, Mohos E, Loderer Z (2004)
Am 88:113–125 Parastomal hernia repair and prevention with PHSL type
3. Cingi A, Cakir T, Sever A, Aktan AO (2006) Enterostomy mesh after abdomino-perineal rectum extirpation. Zent-
site hernias: a clinical and computerized tomographic ralbl Chir 129:149–152
evaluation. Dis Colon Rectum 49:1559–1563 20. Helgstrand F, Gogenur I, Rosenberg J (2008) Prevention
4. Klinge U, Si ZY, Zheng H, Schumpelick V, Bhardwaj RS, of parastomal hernia by the placement of a mesh at the
Klosterhalfen B (2001) Collagen I/III and matrix metallo- primary operation. Hernia 12(6):577–582
57 proteinases (MMP) 1 and 13 in the fascia of patients with
incisional hernias. J Invest Surg 14:47–54
5. White B, Osier C, Gletsu N, Jeansonne L, Baghai M, Sher-
man M, Smith CD, Ramshaw B, Lin E (2007) Abnormal pri- Discussion
mary tissue collagen composition in the skin of recurrent
incisional hernia patients. Am Surg 73:1254–1258
6. Rosch R, Junge K, Knops M, Lynen P, Klinge U, Schumpe-
Schumpelick: Are you not afraid of long-lasting
lick V (2003) Analysis of collagen-interacting proteins in bacteria in this field?
patients with incisional hernias. Langenbecks Arch Surg Berger: These two patients showed that this should
387:427–432 not be a big problem. But these are only two pa-
Chapter 57 · Prophylactic IPOM Mesh To Prevent Parastomal Hernias
449 57
tients, and we started to use it also in the emer-
gency situation.
Schumpelick: You know the study by Leber—that
it will take some years.
Berger: But you also know the opinion by Israels-
son. In his department, he always uses a mesh
even in the contaminated situations. And he uses
it retromuscularly.
Franz: It is outstanding. Have I heard it right?
Should we place the stoma more laterally than the
rectus muscle?
Berger: I found a lot of papers telling us you have
to perform it in the transrectal position, but I also
found papers that showed that there is no differ-
ence where to place.
Schippers: As far as I understand, you use your
technique for permanent stomas. So there will be a
lifelong device in the patient.
Berger: Yes.
Schippers: Any material you implant shows some
kind of migration. How can you be sure that this
will not happen to you?
Berger: I cannot be sure that there will not be any
kind of migration. But correction of migration in
the stoma is much easier than correcting a migra-
tion, i.e. the esophagus.
Schumpelick: That is an argument.
58

Laparoscopic Parastomal Hernia Repair:


Pitfalls and Complications
B. Hansson, I. de Hingh, R. P. Bleichrodt
452 Chapter 58 · Laparoscopic Parastomal Hernia Repair: Pitfalls and Complications

Introduction important issues such as perioperative morbidity


and mortality and long-term recurrence rates after
Parastomal herniation is a common complication parastomal hernia mesh repair.
of stoma formation. The incidence varies signifi- In 2002, we described a laparoscopic technique
cantly and may be as high as 48% for colostomies for repairing parastomal hernias with a prosthetic
and 28% for ileostomies (⊡ Table 58.1) [1]. The dif- mesh [2]. To provide insight into the feasibility
ferent open surgical approaches for treating paras- and safety of this procedure, a prospective clinical
tomal hernias are shown in ⊡ Table 58.2 [1]. Stoma study was started in 2002 [3]. The perioperative
relocation involves relaparotomy and replacement details and early results of the first 55 consecutive
of the stoma to the contralateral side. Besides the patients included in the study are presented.
problem of developing an incisional hernia at the
midline or at the old enterostomy site in 20–30%
of cases, the technique carries a recurrence rate Laparoscopic Repair: A Prospective
of up to 36.3%. Mesh repairs have a lower recur- Study
rence rate of approximately 7.8%. Unfortunately,
most studies are retrospective in design and in- Between 2002 and 2006, adult patients older than
clude only small numbers of patients. Therefore, 18 years with a symptomatic parastomal hernia
it is impossible to draw definitive conclusions on (severe pain, recurrent obstruction, poor fitting
of appliance, cosmetic problems) were asked to
participate in the study. The exclusion criteria were
pregnancy, cardiopulmonary contraindications for
⊡ Table 58.1. Incidence of parastomal hernia [1]
laparoscopy, or life expectancy less than 2 years.
Parastomal Follow-up Besides other information, demographic data,
hernia (%) operative details, perioperative and postoperative
Mean Range Range (months)
complications, time to mobilization, food intake,
stoma production, hospital stay, and 6-week fol-
End colostomy 15.8 4.8–48.1 35–120a low-up data were recorded on a standard form.
Loop colostomy 4.0 0–30.7 2.2–96a

End ileostomy 6.7 1.8–28 2.6a –9.2b Surgical Technique


Loop ileostomy 1.3 0–6.3% 2–3.2a
a The patient is placed in a supine position. A finger
Mean
bMedian condom is inserted into the stoma and fixed with
a transparent adhesive drape so that a finger can
be introduced into the stoma during the operation
⊡ Table 58.2. Approaches and results of open parastomal
and to determine the vitality of the stoma. The
hernia repair surgeon and assistant stand contralateral to the
stoma site. The first trocar is introduced by the
Recurrence (%) Follow-up open Hasson technique, and a pneumoperitoneum
Mean Range Range is created to a pressure of 12 mmHg. A 30° laparo-
(months) scope is inserted, and two or three working ports
are placed under direct vision on both sides of the
58 Stoma relocation 36.3 0–76.1 15–85
camera. After adhesiolysis, the hernia contents are
Onlay mesh repair 2.9 0–33 reduced. The bowel loop that runs to the stoma is
Sublay mesh repair a a a identified and dissected free from the fascial edges.
The hernia opening is narrowed with two nonre-
a a a
Preperitoneal mesh sorbable sutures. A 15×19-cm expanded polytetra-
repair
fluoroethylene patch (e-PTFE; Gore-Tex DualM-
Chapter 58 · Laparoscopic Parastomal Hernia Repair: Pitfalls and Complications
453 58
esh Biomaterial, Gore & Associates, Flagstaff, AZ, be released from the hospital on postoperative
USA) is fashioned with a central keyhole of 2 cm day 4 (range 2–20 days). Postoperative complica-
and two radial incisions of 5 mm (⊡ Fig. 58.1). tions occurred in eight patients (14.4%). Four pa-
This enables a funnel-like shape. The mesh is then tients had to be reoperated: one for bleeding from
inserted, unrolled, and tacked to the abdominal the epigastric artery, one for a mesh infection, one
wall following the double-crown technique. The for peritonitis caused by a small bowel lesion, and
cylindrical part of the mesh forming a small collar one for a leaking colon anastomosis. Nonsurgi-
that surrounds the stoma loop is stitched to the cal complications were observed in another four
bowel wall. patients.
Follow-up at 6 weeks revealed an unevent-
ful recovery in 51 patients (93%). Four patients
Results reported pain at the site of the mesh. On physical
examination, one recurrent parastomal hernia was
Fifty-five consecutive patients fulfilled the inclu- diagnosed in one of the patients in whom conver-
sion criteria and were included in the study. Of sion to laparotomy was performed because of a
the 55 procedures, 47 (85.5%) could be completed full-thickness bowel injury; the hernia was small
laparoscopically. The median operating time was and asymptomatic. Most wound complications had
120 min. Conversion to laparotomy was indicated resolved. Only one residual hematoma was noted,
because of dense adhesions prohibiting safe dis- and persisting seroma at the site of the hernia was
section in four patients and full-thickness bowel noted in three patients.
injury in four. There was no in-hospital mortality. Higher incidences of conversion, intestinal
Postoperative recovery was uneventful in 47 damage, and reoperation occurred in the recurrent
patients (85%). Patients were able to consume a hernia group, but the number of patients was too
normal diet on day 1 (range 1–3 days), had stoma small to reach statistical significance.
production on day 2 (range 1–13 days), and could

Discussion

Laparoscopic parastomal hernia repair is feasible


and seems to be safe since the results are similar
as in open parastomal repair. However, definitive
conclusions cannot be made because the experi-
ence with laparoscopic parastomal hernia repair
is limited; most publications are case series of
moderate quality, and long-term follow-up is lack-
ing. Moreover, prospective randomized trials com-
paring open repair with laparoscopic repair are
not available. Therefore, laparoscopic parastomal
hernia repair cannot be advocated as the standard
of care.
⊡ Fig. 58.1. Keyhole repair of parastomal hernia with a sublay
patch. a An expanded polytetrafluoroethylene patch (Gore-
In the literature, six series of more than five
Tex DualMesh Biomaterial) is fashioned with a central keyhole patients have been published, with 189 patients al-
of 2 cm and two radial incisions of 5 mm to create a funnel. together [3–8]. The median number of patients in
b After the trephine size is narrowed with nonabsorbable these studies is 22, ranging from nine to 66 (⊡ Ta-
sutures, the patch is positioned around the stoma and (a)
ble 58.3). The most frequently used techniques for
fixed with staples using the double-crown technique. By over-
lapping the two parts of the keyhole in the patch, a funnel
parastomal hernia repair are the Sugarbaker tech-
is created (b) around the colon (c). The patch is fixed to the nique (51%) and the keyhole-like technique (39%).
colon with nonresorbable sutures The Sugarbaker technique is a nonslit procedure
454 Chapter 58 · Laparoscopic Parastomal Hernia Repair: Pitfalls and Complications

⊡ Table 58.3. Results of laparoscopic parastomal hernia repair in published series having more than eight patients

Authors, year, N Age Technique Surgical complications Follow- Recur-


design up rence
Intraoperative Postoperative

Safadi [4], 2005 9 63.5 Sugarbaker 0 None Reoperated 0 18–23 4


Retrospective (53–77) Keyhole 9 (44%)
Single center Other Conservative
Ileus 1

LeBlanc et al. 12 ? Sugarbaker 7 Enterotomy 1 Reoperated 20 1


[5], 2005 (42–89) Double patch 5 Delayed rec. 1 (3–39) (8%)
»Prospective« Conversion 0 Ileus 1
Single center
Conservative
Ileus 1
Seroma 1
Died 1

Hansson et al. 55 63 Keyhole 55 Enterotomy 5 Reoperated 6 weeks


[3], 2007 (27–87) Mesh infection 1
Prospective Conversion 8 Peritonitis 2
Single center Hemorrhage 1

Conservative
Ileus 2
Hematoma 5
Seroma 15

Mancini et al. 25 60 Sugarbaker 25 Enterotomy 1 Reoperated 0 19 1


[6], 2007 (41–85) (2–38) (4%)
Retrospective Conversion Conservative
Multicenter Ileus 2
Wound Infection 1
Mesh infection 1
Died 1

Berger et al. 66 70 Sugarbaker 41 Enterotomy 0 Reoperated 24 8


[7], 2007 (34–92) Sandwich 25 Mesh infection 3 (3–72) (12.1%)
»Prospective« Conversion 1 Stoma obstruc- 2
Single center tion
Ileus 2

Conservative
?

McLemore et 19 66+12 Sugarbaker 14 ? ?? Reoperated 20 2


al. [8], 2007 Keyhole 5 Conversion Mesh infection 2 (8–39) (10.5%)
Retrospective Stoma obstruc- 1
Single center tion
58
Conservative
None
Chapter 58 · Laparoscopic Parastomal Hernia Repair: Pitfalls and Complications
455 58
in which a mesh is used to cover the hernia open- ately because of local bleeding, and lesions are not
ing, with an overlap of 4 cm at each side, after the sealed by electrocautery or ultrasonic devices.
stoma loop is lateralized. Lateralization may lead Stoma obstruction or (prolonged) ileus were
to retraction, tilting, and obstruction of the stoma reported in 12 (6.3%) of the 189 patients in the
due to bowel kinking, as was almost exclusively literature. Six patients were reoperated, three for
found in patients treated with this or a similar an obstructed stoma and three for an ileus. Two
technique. The keyhole technique is a procedure patients died as a result of aspiration pneumonia,
in which the patch is draped around the bowel which may have been associated with bowel ob-
(⊡ Fig. 58.1). Berger developed the sandwich tech- struction. Stoma obstruction is reported only in se-
nique, which combines the advantages of both ries that used the (modified) Sugarbaker technique.
methods [7]. Several biomaterials such as polypro- Probably, the lateralization and coverage of the
pylene mesh and e-PTFE have been used for paras- stoma cause kinking and obstruction, especially if
tomal hernia repair, and most parastomal hernias the prosthesis is fixed tight to the abdominal wall.
can be repaired laparoscopically. The conversion Mesh infection was reported in 3.7%, similar
rate in the literature is less than 1%, compared to to infection rates in laparoscopic hernia repair and
8.5% in our series of patients [3–8]. Most conver- lower than in open hernia repair, which may be a
sions in our series were in patients who were reop- benefit of the laparoscopic approach [9].
erated for a parastomal hernia. The mortality was
less than 1%.
The main problems associated with laparo- References
scopic parastomal hernia repair are accidental en-
terotomy, postoperative ileus or stoma obstruction, 1. Carne PWG, Robertson GM, Frizelle FA. Parastomal hernia.
mesh infection, and reherniation. In our series, 9% Br J Surg 2003; 90:784–793
2. Hansson BME, van Nieuwenhoven EJ, Bleichrodt RP. Pro-
of patients had an accidental enterotomy. In four mising new technique in the repair of parastomal hernia.
other series, 1.8% accidental enterotomies were Surg Endosc 2003; 17:1789–1791
reported for 112 patients altogether [4–7]. In 2007, 3. Hansson BME, de Hingh IH, Bleichrodt, RP. Laparoscopic
three reviews were published about laparoscopic parastomal hernia repair is feasible and safe: early results
hernia repair [9–11]. Müller-Riemenschneider et of a prospective clinical study including 55 consecutive
patients. Surg Endosc 2007; 21:989–993
al. [9] reported accidental enterotomies in 3% of
4. Safadi B. Laparoscopic repair of parastomal hernias. Surg
patients who underwent laparoscopic incisional Endosc 2004; 18:676–680
hernia repair. Pierce et al. [10] and LeBlanc et al. 5. LeBlanc KA, Bellanger DE, Whitaker JM. Laparoscopic pa-
[11] reported an enterotomy incidence of 2.9% rastomal hernia repair. Hernia 2005; 9:140–144
and 1.8%, respectively, during laparoscopic ventral 6. Mancini GJ, McCluskz III DA, Khaitan L, et al. Surg Endosc
2007; 21:1487–1491
and incisional hernia repair. Especially if unrec-
7. Berger D, Bientyle M. Laparoscopic repair of parastomal
ognized, bowel perforations represent a serious hernias. A single surgeon’s experience in 66 patients. Dis
and potentially life-threatening complication [11]. Colon Rectum 2007; 50:1668–1673
Accidental enterotomies are recognized in 82% 8. McLemore EC, Harold KL, Efron JE, et al. Parastomal hernia
of cases during the first operation and are associ- short term outcome after laparoscopic and conventional
ated with a mortality of 1.7%. Eighteen percent of repairs. Surg Innov 2007; 14(3):199–204
9. Müller-Riemenschneider F, Roll S, Friedrich M, et al. Medi-
enterotomies are diagnosed in the postoperative
cal effectiveness and safety of conventional compared to
period and have a significantly higher mortality of laparoscopic incisional hernia repair: a systematic review.
7.7% [11]. With laparoscopy, the risk of accidental Surg Endosc 2007; 21:2127–2136
enterotomy seems to be higher than in open sur- 10. Pierce RA, Spitler JA, Frisella MM, et al. Pooled data analy-
gery. To prevent full-thickness bowel lesions, adhe- sis of laparoscopic vs. open ventral hernia repair: 14 years
of patient data accrual. Surg Endosc 2007; 21:378–386
siolysis should be performed by sharp dissection,
11. LeBlanc KA, Elieson MJ, Corder JM 3rd. Enterotomy and
without the use of electrocautery or ultrasonic mortality rates of laparoscopic incisional and ventral her-
devices. Sharp dissection has the advantage that nia repair: a review of the literature. JSLS 2007; 11(4):408–
a serosal bowel lesion can be recognized immedi- 414
59

Concept of Visible Mesh and


Possibilities for Analysis of Mesh
Migration and Shrinkage
J. Otto, N. Krämer, G. A. Krombach, I. Slabu, M. Hodenius, M. Baumann,
U. Klinge
458 Chapter 59 · Concept of Visible Mesh and Possibilities for Analysis of Mesh Migration and Shrinkage

After incorporation, textile meshes change their constructed (SF mesh). To compare this mesh with
appearance markedly because of tissue ingrowth a conventional UltraPro mesh, they were both
and integration into scar tissue. Migration and placed in a phantom model consisting of two
erosion, shrinkage and deformation, and fistula pieces of meat surrounded by water to evacuate
formation are rare but severe complications. To air. ⊡ Figure 59.4 shows a coronal slice of the two
appreciate the clinical relevance, we have to keep meshes. Only the nanoparticle-containing SF mesh
in mind that 1.5 million meshes are implanted
per year worldwide [1]. After mesh implantation,
a significant number of patients will present to a
doctor with mesh-related problems sooner or later.
Among these may be either newly developed pain
in the groin, functional problems in the hiatus if
the mesh was placed around the oesophagus, or
manifestation of fistulas to the intestines.
To decide whether to monitor the complaints,
surgically correct the position of the mesh, or
explant the mesh, a central question must be an-
swered: Is a dislocation of the mesh causing the
current complaints?
X-ray, ultrasound, computed tomography (CT),
and magnetic resonance imaging (MRI) are the
main radiological imaging methods at hand for pos-
sibly answering this question. However, X-ray is not
able to show the mesh itself; only the metal surgical
clips used for fixation may be visible (⊡ Fig. 59.1).
With ultrasound, the mesh cannot be distin-
guished from the ambient structure if the mesh has
been incorporated with no seroma, infection, or
scar formation because the signal differences are
too small to separate the mesh from the surround- ⊡ Fig. 59.1. X-ray after mesh implantation; mesh fixation with
ing tissues (⊡ Fig. 59.2). metal tacks (arrows)
Computed tomography and MRI struggle with
the same problem: In the case of mesh incorpora-
tion with no complications, it is almost impossible
to identify the mesh and reveal its exact localisa-
tion. Only in exceptional cases, if the mesh is sur-
rounded by fluids or fat, can the fine structure of
the mesh be delineated [2–4] (⊡ Fig. 59.3). Besides
these exceptions, X-ray, ultrasound, CT, and MRI
usually fail to directly visualise the mesh device.
To achieve an MR-visible polymer device, we
use superparamagnetic nanoparticles of ferrofluids
[5]. These superparamagnetic iron oxides are also
used as MR contrast media. On MRI, the nano-
59 particles cause a signal decrease by disturbing the
magnetic field, resulting in a hypointense signal.
A new textile mesh made from polyvinylidene
fluoride with superparamagnetic particles has been ⊡ Fig. 59.2. Mesh (arrow) surrounded by seroma (star)
Chapter 59 · Concept of Visible Mesh and Possibilities for Analysis of Mesh Migration
459 59
could be visualised by the desired susceptibility ar- to identify and locate the mesh (⊡ Fig. 59.5) on MR
tefacts. These artefacts enabled an increased differ- images. With the aid of a dedicated small animal
entiation from the tissue, which was not possible receiver coil and an imaging sequence providing
using UltraPro mesh. high resolution, even the pores of the mesh could
Based on these results, a prototype of the »vis- be delineated. However, this is possible only with
ible« mesh was implanted as an inlay into the long data acquisition.
abdominal wall of a dead rat. Again, it was possible If the concentration is too high, the signal will
strongly exceed the diameter of the mesh fibre. Af-
ter proving that textile structures can be visualised
using MRI by adding superparamagnetic particles,
future work should optimise the particle size, the
concentration in relation to the fibre size, and
the MRI sequences. Knowledge of the magnetic
properties of the mesh is important for developing
models of MR signalling behaviour. On account of
this, the magnetic susceptibility will be determined
by superconducting interference device (SQUID)
measurements. The final goal will be to find a
method to image the mesh with a clear delinea-
tion of its surrounding structures. Because neither
air nor susceptibility artefacts provide signals, a
method to differentiate air from susceptibility arte-
facts with positive contrast is desirable.
Such a visible mesh will be helpful both for de-
⊡ Fig. 59.3. Computed tomographic image after mesh hiato- ciding whether a revision operation of the mesh is
plasty. It is not possible to see the mesh beside the metal tacks necessary and as a tool for constructing improved

⊡ Fig. 59.4. Magnetic resonance


image (MRI): Visible mesh vs. Ul-
trapro. No signal can be detec-
ted from the UltraPro mesh; the
SF mesh causes mild signal loss
(open arrow). Macroscopy: Upper
arrow indicates UltraPro with
blue stripes. Lower arrow indi-
cates colourless mesh of fibres
that include superparamagnetic
ferroparticles (SF mesh). Both
meshes were placed between
air-filled plastic tubes
460 Chapter 59 · Concept of Visible Mesh and Possibilities for Analysis of Mesh Migration and Shrinkage

⊡ Fig. 59.5. Magnetic reso-


nance image of abdominal
wall replacement with visib-
le mesh in a rat model

meshes that, it is hoped, will have less shrinkage 5. Hodenius MA, Niendorf T, Krombach GA, Richtering W,
and less risk of migration, particularly for areas Eckert T, Lueken H, Speldrich M, Gunther RW, Baumann
M, Soenen SJ et al. Synthesis, physicochemical charac-
with a lot of mobility, such as the hiatus and the terization and MR relaxometry of aqueous ferrofluids. J
pelvic floor. Nanosci Nanotechnol 2008, 8:2399–2409

Acknowledgements
Discussion
This work was supported by the German Fed-
eral Ministry of Education and Research (BMBF Schumpelick: Are you sure that every surgeon
01EZ 0849). would be glad to know where his mesh is?
Otto: Probably not.
Fitzgibbons: Are none of the others visible?
References Otto: It depends on the contrast. Just very thick
meshes in cases of seromas are able to see.
1. Junge K, Klinge U, Rosch R, Mertens PR, Kirch J, Klosterh-
Schumpelick: And what about nanoparticles? Any
alfen B, Lynen P, Schumpelick V. Decreased collagen type
I/III ratio in patients with recurring hernia after implanta-
dangers to their use?
tion of alloplastic prostheses. Langenbecks Arch Surg Otto: They are already in use.
2004, 389:17–22
2. Crespi G, Giannetta E, Mariani F, Floris F, Pretolesi F, Ma-
rino P. Imaging of early postoperative complications after
polypropylene mesh repair of inguinal hernia. Radiol Med
(Torino) 2004, 108:107–115
3. Di MM, Runfola M, Magalini S, Sermoneta D, Gui D. Rip-
pled mesh: a CT sign of abdominal wall ePTFE prosthesis
infection. G Chir 2006, 27:384–387
59 4. Fischer T, Ladurner R, Gangkofer A, Mussack T, Reiser M,
Lienemann A. Functional cine MRI of the abdomen for
the assessment of implanted synthetic mesh in patients
after incisional hernia repair: initial results. Eur Radiol
2007, 17:3123–3129
VI

VI Strategy to Improve Results

60 Who Has the Major Role in Hernia Surgery:


The Surgeon or the Material? – 463

61 Two Controversial Concepts: Standard Procedure


in a Standard Patient Versus Tailored Surgery with
Procedures Adjusted to Individual Patients – 467
60

Who Has the Major Role in Hernia


Surgery: The Surgeon or the Material?
R. C. Read
464 Chapter 60 · Who Has the Major Role in Hernia Surgery: The Surgeon or the Material?

Introduction ing that this period of supervision was inadequate.


The authors point out that at the Shouldice clinic,
Astley Cooper (1804), in the preface to his classic new staff surgeons receive close supervision for
monograph on the anatomy and surgical treatment their first 50 herniorrhaphies and do not operate
of hernia [1], wrote, »No disease of the human independently until they have repaired 100. A final
body belonging to the province of the surgeon, assessment of their technique is made after 1,000
requires in its treatment a greater combination of hernias have been operated upon.
accurate anatomical knowledge with surgical skill, A similar finding of junior staff incurring a
than hernia in all of its varieties.« More recently, in high incidence of early recurrence after inguinal
1989 George Wantz stated, »The outcome of an in- herniotomy in children was reported by Harvey
guinal hernioplasty is more dependent on the skills et al. [7]. Poor technique was considered to be
and experience of the surgeon than on the type of responsible. The authors recommended that the
repair« [2]. In 2006, Gilbert et al. [3] averred, »The practice of placing hernia cases at the end of the
use of any mesh product to repair a hernial defect operating room list, thereby allowing junior staff
will never supplant the need to fully know and to work on them unsupervised, be discontinued.
utilize the layers, planes and spaces of the abdo-
men.« The purpose of this chapter is to document
evidence supporting these judgments. Prostheses [8]

Reinforcement of sutured repairs in the groin using


Sutured Repair metallic filigrees began soon after Bassini intro-
duced his cure (1887). During World War II, they
The importance of the surgeon’s experience in pre- were replaced with plastic meshes by Aquaviva
venting recurrence after hernia repair is exempli- and Bounet. The Lichtenstein procedure (1984),
fied by the trend toward making herniology a sub- using onlay polypropylene, became the gold stan-
specialty of general surgery. Glassow [4], in a 1970 dard for inguinal herniorrhaphy in the 1990s. It
review of 50,000 groin herniorrhaphies performed supplanted the Shouldice operation because the
at the Shouldice Hospital, pointed out that the in- recurrence rate was significantly less. Because the
cidence of recurrence fell from 17% to 1% within approach was anterior, through familiar anatomy,
two decades after this herniological institute was there seemed to be no need for a specific training
founded (1945). The improvement was attributed period.
to modifications made to the original Shouldice Positioning of mesh behind the transversalis
procedure in the 1950s and to specialization. The fascia is more difficult because the preperitoneal
first detailed analysis of the relationship between space is unfamiliar territory. The open posterior
a surgeon’s operative experience of groin hernio- approach to both groins was pioneered by Cheatle
plasty and recurrence was provided by Kingsnorth and Henry [9]. McEvedy introduced the unilateral
et al. in 1981 [5]. Consultants and senior registrars procedure in 1950 [9]. Stoppa [10] employed the
who had performed more than six such proce- bilateral access for prosthetic repair and, in his early
dures had a 2.5% recurrence rate, whereas the experience, had a high rate of recurrence. Similarly,
figure for registrars with less experience was 9.4% Wantz, with this operation, reported a figure of
(calculated to be 28% in 25 years). The authors 11.6% in his first 40 patients [11]. Subsequently,
therefore recommended careful supervision, by a this rate fell to 1.9%. Fernandez-Lobato et al. [12]
consultant, of six herniorrhaphies before juniors believed the Stoppa technique required an initial
could become principal operators. A subsequent learning curve of 20–30 cases. Kurzer et al. [13], us-
study in 1992 [6] also involved registrars who ing Wantz’s unilateral posterior preperitoneal repair
were supervised while performing their first six for anterior groin recurrences and thereby avoiding
Shouldice operations. Their later high recurrence scar, had 25% of their operations recur in their first
60 rate of 4.5% was blamed on inexperience, indicat- 20 patients. Later, the figure was 1%.
Chapter 60 · Who Has the Major Role in Hernia Surgery: The Surgeon or the Material?
465 60
Schroder et al. [14] found a recurrence rate of that they could avoid initial complications, includ-
18.2% in their first 36 patients who received the ing recurrence. Kingsnorth [5] did likewise for reg-
Kugel patch preperitoneal hernioplasty. The later istrars. Later, the new gold standard for groin repair,
incidence was 2.9%. The overall results with open the Lichtenstein operation, was exempted because
posterior preperitoneal prosthetic repair indicate its rate of recurrence was significantly less than
that there is a learning curve during which com- that of the supplanted Shouldice procedure. Prep-
plications, including recurrence, are more likely. eritoneal prosthetic repair required more training
Schroder et al. [14] considered its extent to be 40 (20–30 cases). A similar learning curve was recom-
cases, and Van Nieuwenhove et al. [15], in a study mended for the repair of incisional and hiatal herni-
of 450 Kugel repairs, estimated a training period of ation, open or laparoscopic. Laparoscopic repair of
25–35 patients, depending on the surgeon’s experi- inguinal herniae required a more extended learning
ence with the anatomy. Similar learning curves curve (30–50 cases). However, in 2004 a multicenter
were developed for incisional herniation and hiatal Veterans Administration study [21] indicated that
herniae, the latter for open [16] and laparoscopic for general surgeons, even this figure was inad-
repair [17]. equate. A later follow-up in 2005 [22] raised the
The principles of open anterior or posterior question of whether aging countered the value of
preperitoneal mesh herniorrhaphy apply to laparo- surgical experience when sophisticated technology,
scopic repair. Therefore, experience with the former i.e., laparoscopy, is employed. These data support
facilitates performance of the latter, which is tech- the axioms of pioneering herniologists.
nically demanding and therefore requires an ex-
tended learning curve if initial recurrences are to be
avoided. Wright and O’Dwyer [18] suggested that References
30–40 supervised cases are needed for the groin.
Beets et al. [19] quoted a consensus of 50 repairs, 1. Cooper AP (1804) The anatomy and surgical treatment of
inguinal and congenital hernia [preface]. Cox, London
while DeTurris et al. [20] cited 30–50. Neumayer
2. Wantz GE (1989) The Canadian repair: personal observa-
et al. [21], comparing the results of open mesh and tions. World J Surg 13:516–521
laparoscopic repair of inguinal hernia in male vet- 3. Gilbert AI, Graham MF, Young J, et al. (2006) Closer to
erans, found that general surgeons who were super- ideal solution for inguinal hernia repair: comparison bet-
vised for their initial 25 laparoscopic hernioplasties ween general surgeons and hernia specialists. Hernia
10(20:162–168
had a later recurrence rate that plateaued only after
4. Glassow F (1970) Recurrent inguinal and femoral hernia.
250. It appeared that an inexperienced surgeon em- BMJ (1):215–216
ploying this new and demanding technique requires 5. Kingsnorth AN, Britton BJ, Morris PJ (1981) Recurrent
more training. However, in a later report [22], these inguinal hernia after local anesthetic repair. Br J Surg
authors raised the question of whether, despite ex- 68:273–275
6. Kingsnorth AN, Gray MR, Nott DM (1992) Prospective
perience, aging affects a surgeon’s performance, es-
randomized trial comparing the Shouldice technique and
pecially using newer, more challenging techniques, plication darn for inguinal hernia. Br J Surg 79(10):1068–
such as laparoscopy and robotics. 1070
7. Harvey MH, Johnstone MJS, Fossard DP (1985) Inguinal
herniotomy in children: a five year survey. Br J Surg
Conclusions 72:485–487
8. Read RC (2004) Milestones in the history of hernia sur-
gery: prosthetic repair. Hernia 8(1):8–14
In summary, pioneers in herniology have, over the 9. Read RC (2001) Use of the preperitoneal space in ingu-
last two centuries, asserted that a surgeon’s skills and inofemoral herniorrhaphy: historical considerations. In:
experience are more important than the material Bendavid R (ed) Abdominal wall hernias: principles and
management. Springer, New York, pp 11–15
used to cure abdominal herniation. These senti-
10. Stoppa RE, Warleumont CR (1989) The preperitoneal ap-
ments encouraged the development of herniology proach and prosthetic repair of groin hernia. In: Nyhus
as a subspecialty of general surgery. The Shouldice LM, Condon RE (eds) Hernia, 3rd edn. Lippincott, Philadel-
clinic [4] introduced learning curves for new staff so phia, pp 199–216
466 Chapter 60 · Who Has the Major Role in Hernia Surgery: The Surgeon or the Material?

11. Wantz GE (1989) Giant prosthetic reinforcement of the


visceral sac. Surg Gynecol Obstet 169:408–417
12. Fernandez-Lobato R, Tartas-Ruiz A, Jimenez-Miramon FJ
(2006) Stoppa procedure in bilateral inguinal hernia. Her-
nia 10(2):179–183
13. Kurzer M, Belsham PA, Kark AE (2002) Prospective study
of open preperitoneal mesh repair for recurrent inguinal
hernia. Br J Surg 89:90–93
14. Schroder DM, Lloyd LR, Boccaccio JE, et al. (2004) Inguinal
hernia recurrence following preperitoneal Kugel patch
repair. Amer Surg 70:132–136
15. Van Nieuwenhove Y, Vansteenkiste F, Vierendeels T, et al.
(2007). Open preperitoneal hernia repair with the Kugel
patch: a prospective multicenter study of 450 repairs.
Hernia 11(1):9–13
16. Orringer MB, Skinner DB, Belsey RH (1972) Long term
results of the Mark IV operation for hiatal hernia and
analyses of recurrences and their treatment. J Thorac
Cardiovasc Surg 63:25–33
17. Puri V, Kakarlapudi GV, Awad ZT, Filipi CJ (2004) Hiatal
hernia recurrence: 2004. Hernia 8(4):311–317
18. Wright D, O’Dwyer RJ (1998) The learning curve for lapa-
roscopic hernia repair. Semin Laparoscop Surg 5(4):227–
232
19. Beets GL, Dirksen CD, Go PMNYH, et al. (1999) Open or
laparoscopic preperitoneal mesh repair for recurrent in-
guinal hernia? Surg Endoscop 13:323–327
20. DeTurris SV, Cacchione RN, Mungara A, et al. (2002) Lapa-
roscopic herniorrhaphy: beyond the learning curve. J Am
Coll Surg 194 (15):65–73
21. Neumayer L, Giobbie-Hurder A, Jonasson O, et al. (2004)
Open mesh versus laparoscopic mesh repair of inguinal
hernia. N Engl J Med 350(18):1819–1827
22. Neumayer LA, Gawande AA, Wang I, et al. (2005) Pro-
ficiency of surgeons in inguinal hernia repair: effect of
experience and age. Ann Surg 243 (3):344–352

60
VII

VII Pro and Contra

62 In Support of a Standard Technique for Inguinal


Hernia Repair – 475

63 In Support of Individual Selection of Technique as


Related to the Patient–Improvement by Better Selection
of Patients Who Can Be Offered a Less Risky Technique:
Groin Hernia – 479

64 In Support of Standard Procedure in Abdominal


Hernia Repair – 485

65 In Support of Individualized Procedures in Abdominal


Wall Hernia Repair – 493

66 In Support of Standard Procedure in Hiatal Hernia


Repair – 503

67 Strategy To Improve the Results? In Support of


Individualized Procedures in Hiatal Hernia Repair – 513

68 Questionnaire – 521
61

Two Controversial Concepts:


Standard Procedure in a Standard
Patient Versus Tailored Surgery with
Procedures Adjusted to Individual
Patients
U. Klinge and A. Fiebeler
468 Chapter 61 · Two Controversial Concepts: Standard Procedure in a Standard Patient Versus Tailored Surgery

Introduction more numerous proteins have to be considered.


61 Furthermore, if a relevant impact of these biologi-
Surgeons have been working for decades to improve cal conditions is suspected, it is obviously impos-
their technique and to develop better procedures. sible to control all of these components in detail.
In doing so, they try to prove the effect of every Consecutively, on the molecular level it has to be
modification by clinical randomized controlled tri- accepted that every patient will react and respond
als (RCTs). The process should result in a best a little bit differently than another. Thus, this sec-
technique that can then be considered the gold stan- ond concept assumes relevant differences between
dard. This recommendation is outlined in so-called every individual and consequently results in an
guidelines offering evidence-based knowledge to individual disease that requires individualization
every physician. However, although RCTs have been of therapies. The second concept may best reflect
performed with increasing efforts, these often fail the true diversification of diseases; however, it is
to confirm any significant differences between the unsuitable for developing practical approaches to
groups involved. Furthermore, after replication by treat our patients. The resulting picture of thou-
other investigators, the overall results differ con- sands of individual diseases and treatments is too
siderably in outcome, making interpretation of the complex to derive principles and guidelines that
results rather complicated. Even the collection of can be taught to our students and residents.
several trials in meta-analyses often does not ease A compromise between the two extremes can
interpretation. It appears that for some questions, be a third concept that considers several subgroups
the RCT instrument needs some support to verify of patients with prognostic differences in disease
the superiority of one procedure over another. progress, each demanding specific stage-related
What might be the reason that even marked ex- therapies. This concept is already well established
pansion of cohort size frequently does not show clearer for cancer therapy; cancer surgery is adapted to
results? For explanation, it may be helpful to look at the tumor stage to provide comparable subgroups,
our general concepts of disease in more detail. which can then be tested by RCTs. Instead of the
first concept being applied, tumor patients are con-
sidered to be nonhomogeneous and are grouped
Different Concepts of Disease according to certain influencing constellations con-
cerning their prognosis for survival. According to
A disease is assumed to be best treated in a stan- defined risk factors, different therapies are tailored
dardized way, and its impact on the outcome can to each individual patient, forming a decision tree
be tested by an RCT. An RCT is based on the as- for selecting the individualized best therapy.
sumption that the disease process is uniform in In the following, we discuss whether the opti-
every patient. Individual patients are considered mal therapy for hernia can be derived from apply-
as average patients since their individual differ- ing the first concept or whether better results can
ences will be compensated for by randomization. be achieved by using the latter concept, which is
This first concept of assuming one disease treated also referred to as a »tailored approach.« Further-
by one standard therapy is the domain of the more, general remarks are given on how to identify
RCT and usually does not offer serious problems. therapies with a clear causal impact on the result as
This is true for many experimental settings with a predicted by the first concept and how to test the
limited and known number of influencing effects. quality of a tailored approach.
However, for others the number of factors relevant
to the prognosis seems to be uncountable. Besides
technical aspects, an increasing number of biologi- A Century of Seeking the Best Standard
cal reasons seem to interfere with the results, e.g., Procedure To Repair a Hernia?
gene polymorphism or functional imbalances in
the proteosome. Unfortunately, we do not know The surgical repair of groin hernia started with
which of the 40,000 genes (or all?) and the even Bassini in 1884 as a suture repair, was modified
Chapter 61 · Two Controversial Concepts: Standard Procedure in a Standard Patient
469 61
by Shouldice in 1944, and changed toward mesh using meshes in the huge majority of our patients.
repair with the introduction of the Lichtenstein What might be the reason that we could not solve
repair in 1986 and the laparoscopic procedures this simple technical problem, and why did many
at the beginning of the 1990s. Since Bassini, the RCTs fail to lead to significant improvement of our
recurrence rate for suture repair had been <5% in techniques?
selected patients, but the long-term recurrence rate
was widely constant around 10–15%. Treatment
of recurrent hernia had been more difficult, with Recurrence as a Technical Failure?
recurrence rates of up to 30–50%. Reinforcement
of tissue with meshes improved the results, with From an engineer’s technical point of view, ab-
recurrence rates of <1% in selected patients [1], a dominal wall hernia repair needs any adequate
long-term rate of 5–10%, and a rerecurrence rate procedure to simply close the hernia gap. A perfect
of 10–20% [2]. Several meta-analyses concluded technique and procedure should be decisive for the
that meshes reduce the recurrence rate by half, result and should permanently prevent recurrence.
regardless of whether they are implanted in open However, in some cases a technical failure may
surgery or laparoscopically [3]. In the guidelines occur and will result in recurrence. For a group
of many countries (including the United Kingdom of comparable cases, this should manifest after a
and the Netherlands), Lichtenstein mesh repair is mean delay of some months or years (± standard
claimed to be the standard operation for primary deviation). If a procedure is used that works better,
hernia in the adult patient [1]. there may be either fewer recurrences or the recur-
Incisional hernia of the abdominal wall is even rence should appear later (⊡ Fig. 61.1).
more difficult to treat. Despite countless attempts As a consequence, the outcome curve will show
to improve the standard technique for closing a an S-shaped configuration with its transflexion
laparotomy, the long-term incidence for develop- point at the time of peak incidence. This is well
ing an incisional hernia is up to 20%, and for known for engineers and is in accordance with car
parastomal hernia it is even higher, up to 50%. breakdowns due to certain technical defects [5].
The rerecurrence rate after suture repair is >50%. Correspondingly, if we assume that every patient
Again, reinforcement with meshes markedly re- with any kind of hernia is treated with a standard
duces the recurrence rate to <10% [4]. To date, procedure, in the case of a standard patient with a
there is no evidence regarding whether the onlay standard hernia we should expect that recurrences
position is as good as the sublay position in all develop after a standard delay ± standard deviation.
cases, but mesh repair is regarded as the standard
for repair of incisional hernia.
After more than 100 years of improving our Recurrence
technical skills, we can state that reinforcement of
tissues by meshes hinders recurrence. However,
despite many attempts to identify the best closure
technique, we still do not know how to close a lap-
arotomy sufficiently. And up to now, no RCT has
proven any beneficial effect of a new technique.
What might the technical challenge be when ap-
proximating just two layers of the abdominal wall?
Until now, despite the clear and evident supe-
riority of mesh techniques proven by many RCTs
(and even several meta-analyses), we are still op-
Time
erating on 10–15% of our patients with a groin
hernia because of a recurrent hernia–for decades ⊡ Fig. 61.1. Incidence of a technical failure (recurrence; red
without any sign of reduction even though we are solid line) and its cumulative incidence curve (blue dotted line)
470 Chapter 61 · Two Controversial Concepts: Standard Procedure in a Standard Patient Versus Tailored Surgery

Do we have data to support such courses of Time course of failure with linear rise
61 hernia recurrences? No, clearly this is not the rule. due to accumulation of many incidences
Studying incisional hernia in a long-term survey, 1
Incidence of damage
Luijendijk et al. found unexpectedly high rerecur-
cumulative »survival«
rence rates even after mesh repair: >60% after
suture and >30% after mesh repair [6, 7]. Many of
these recurrences developed after a long delay from
the previous operation, and even more intriguing,
the courses showed cumulative incidences that
formed curves with a roughly linear shape. Similar
courses are seen in the cumulative rate of opera-
tions for recurrence depicted from epidemiological
0
databases. In contrast to the expected peak inci- Time
dence with an S-shaped outcome curve, for groin
⊡ Fig. 61.2. Incidences of several possible failures (red solid
hernia [1] as well as for incisional hernia [8], the line) and their superimposition toward a linear rise in the cu-
cumulative incidence rises constantly over time, mulative incidence curve (blue dotted line)
not showing any S-shaped inflexion or reaching a
plateau at the end.
Is this really worth thinking about? And does
it help addressing the problem of standard versus comparable in their failure risk or a mechanism to
tailored treatment? be tested that has an undoubted causal relevance
Regarding the linear rise of a cumulative recur- for the occurrence of a failure. Neither may be as-
rence rate, the best explanation is still that there sumed in the case of linear outcome curves. In the
is not one specific reason but that there are many case of linear cumulative incidences, an alternative
of them. Conclusively, the development of a re- therapy may show a reduced rate of complications
currence cannot be related to one (i.e., technical) at any time point; however, without having reached
problem that can be overcome by one technical a plateau, it is only a delayed manifestation of the
solution. In other words, it is unlikely for one stan- problem. Furthermore, if the results are not cor-
dard procedure to address all of these problems rected for age-related morbidity, every delay per se
and to improve all results significantly. will suggest a reduced number of complications.
Consequently, if we do not see a standard fail- In summary, the configuration of epidemio-
ure with a standard delay resulting in an S-shaped logical outcome curves indicates that recurrences
outcome curve, it must be suspected that the basic should not be regarded as simple technical failures
assumption of a standard patient with a standard but rather as a complex problem of biology, and
hernia is not advantageous. Recent investigations that we should not look for a standard failure in a
of wound healing confirm the evidence that recur- standard patient.
rence in hernia patients is a problem of a defective
biological network rather than a technical failure.
Because the defective scarring process is triggered Technical Solution for a Complex
by a complex network of biological interferences, it Biological Problem
is not surprising that the causally relevant reason
may differ with each patient. The superimposi- Currently, the technical solution to the biologi-
tion of all the many different possible reasons with cal problem means reinforcement of tissue with
their different incidence peaks will result in a meshes. One way to overcome poor-quality scar-
linear rise of the outcome curve, as in fact is seen ring in patients is to supply an extended sub-
in patients after hernia repair (⊡ Fig. 61.2). Not the duction of the mesh underneath healthy scar-free
least consequence of this model is that it questions tissue. The important question for the surgeon is
the role of RCTs. These require either (sub)groups whether the overlap that can be achieved by a stan-
Chapter 61 · Two Controversial Concepts: Standard Procedure in a Standard Patient
471 61
dard technique is independent of the patient’s indi- to the procedure must show whether any problems
vidual type of hernia or whether it is necessary to were caused by poor technique in the right patient
tailor various techniques to the individual patient. or by good technique in the wrong patient. If tech-
We present some considerations that all indicate nical failure is suspected, surgical skills need to be
that the procedure must at least be selected in view improved. If a technical failure can be excluded
of hernia size and location. and the problem was simply the wrong technique
A larger hernia gap needs a larger mesh. How- for the patient concerned, the decision tree needs
ever, in the case of a large mesh, even small shrink- to be modified such that the next similar patient
age of <15% may reduce the absolute width of the will receive a more appropriate technique. After
mesh by >4 cm and thereby cut the overlap in half! some time, all results have to be checked again.
Next, surgeons should consider that positioning Furthermore, all results need to be compared with
the mesh on fat tissue is more likely to result in other clinics and other decision trees. Finally, it is
slippage of the mesh and shortening of the over- likely that decision trees with the best results will
lap; thus, larger meshes will be advantageous in be rather similar; however, it will be possible to
such cases. This is in accordance with the clinical achieve good results with several different decision
results of increased recurrence rates in adipose trees in different target groups of patients.
patients when the mesh had been placed in the Not the least advantage is that for this tailored
preperitoneal fat [9]. Furthermore, there are some approach, no patient has to be randomized; there-
areas of concern where anatomy makes it difficult fore, every surgeon and every clinic can take part in
to supply a sufficient overlap, such as close to bony a comprehensive comparison of patients’ outcomes.
structures (e.g., the iliac crest or costal arch). In Even in theory, a tailored approach will lead
these locations, intraperitoneal onlay mesh tech- to superior results if corresponding subgroups can
niques may provide greater overlap than meshes in be identified. Whereas for an entire cohort two
the onlay position. Because the various techniques therapies may have a similar complication rate,
differ considerably in the mesh size used and the this may be eliminated if the procedure is tailored
overlap that is achievable by dissection, we must to subgroups with less risk for a specific therapy
tailor the procedure to the patient. This means we (⊡ Fig. 61.3).
have to select the technique that fits best and that The previous remarks focus on recurrence;
provides the biggest overlap with the lowest risk however, the principal aspects of a tailored ap-
for the patient. proach should be applied for many other treatment
regimens, such as for curing infection, pain, etc.
Further, it is necessary to weight the importance
Principle and Quality Control and relevance of the complications, advantages,
of Tailored Surgery and disadvantages to the patient and the surgeon
as well as to the institution.
The concept of tailored surgery does not mean
treating patients according to some vague expert’s
opinion. Quality control is required, just as for ev- Conclusion
ery other therapeutic concept, although the evalu-
ation of a decision tree requires studies other than Although we may not feel comfortable with it,
the RCT. we have to accept that there is no easy scientific
The final goal of any tailored approach is to answer [10] that offers the one golden solution.
achieve the best result in all patients, while using Only in the case of S-shaped outcome curves we
various techniques in nonhomogeneous groups of are allowed to assume that we are treating standard
patients. First of all, we have to define criteria for patients with standard procedures, and in this
such a decision tree regarding which patient should case we are right to expect standard results. In the
receive which technique. Checking the results after case of linear outcome curves, we should consider
x time and analyzing the complications in relation whether a tailored approach is more appropriate.
472 Chapter 61 · Two Controversial Concepts: Standard Procedure in a Standard Patient Versus Tailored Surgery

Assumption szenario III: „tailored approach“


61
Technique 1: laparoscopical Technique 2: open

5% A B A B 5%

B A

Technique 2 (open) A B Technique 1 (laparoscopical)


for patients of group A for patients of group B
(suprasymh., subxiphoid.) (lateral, close to bones)

⊡ Fig. 61.3. Two different techniques, each with 5% complications. For technique 1 it manifests in subgroup A, whereas for tech-
nique 2 it occurs in subgroup B. A tailored approach with treatment of A with technique 2 and of B with technique 1 will even
be able to eliminate all complications

However, once we have identified subgroups of 6. Luijendijk RW, Hop WC, van den Tol MP, et al. (2000) A
patients with identical risk profiles for a complica- comparison of suture repair with mesh repair for incisio-
nal hernia. N Engl J Med 343:392–8
tion, S-shaped outcome curves should be available
7. Burger JW, Luijendijk RW, Hop WC, et al. (2004) Long-term
for these patients, and those subgroups then should follow-up of a randomized controlled trial of suture ver-
be compared with RCTs. If not, we should try to sus mesh repair of incisional hernia. Ann Surg 240:578–83;
improve the quality of our decision tree for the discussion 583–5
tailored approach. Nevertheless, there is no doubt: 8. Flum DR, Horvath K, Koepsell T (2003) Have outcomes of
incisional hernia repair improved with time? A populati-
Every procedure has to be performed carefully and
on-based analysis. Ann Surg 237:129–35
correctly according to the well-established stan- 9. Rosemar A, Hana N, Ulf A, Staffan H, Pär N (2008) Groin
dards–which means, tailor your standards! hernia surgery and body mass index: a study based on a
national register (S). In: Proceedings of the 30th Congress
of EHS GREPA, Sevilla, Spain, 7–10 May 2008
10. Klinge U, Dahl E, Mertens P (2007) Problem poser–how
References to interpret divergent prognostic evidence of simultane-
ously measured tumor markers? Comput Math Methods
1. Schumpelick V, Fitzgibbons R (2007) Recurrent hernia– Med 8:71–75
prevention and treatment. Springer, Berlin
2. Eklund A, Rudberg C, Leijonmarck CE, et al. (2007) Recurrent
inguinal hernia: randomized multicenter trial comparing la-
paroscopic and Lichtenstein repair. Surg Endosc 21:634–40
3. McCormack K, Scott NW, Go PM, Ross S, Grant AM (2003)
Laparoscopic techniques versus open techniques for in-
guinal hernia repair. Cochrane Database Syst Rev 2003
(1):CD001785
4. Klinge U, Krones CJ (2005) Can we be sure that the mes-
hes do improve the recurrence rates? Hernia 9:1–2
5. Klinge U, Binnebösel M, Rosch R, Mertens P (2006) Hernia
recurrence as a problem of biology and collagen. J Minim
Access Surg 2:151–4
62

In Support of a Standard Technique


for Inguinal Hernia Repair
M. P. Simons
476 Chapter 62 · In Support of a Standard Technique for Inguinal Hernia Repair

Introduction
⊡ Table 62.1. Factors that influence the possibility of
using one standard technique in inguinal hernia repair
Is standardisation of treatment of inguinal hernia (ASA American Society of Anesthesiologists)

62 necessary? Yes, it is necessary because the vast


Patient-related
majority of surgeons are not dedicated hernia sur-
 Gender
geons, so they need guidance and training. Look-  Obesity
ing for a »standard« technique that is (relatively)  ASA class
easy to learn, safe, cheap, reliable, and reproducible  Prior groin surgery
is important.  Comorbidity
 Type of anaesthesia
In this chapter, factors that influence the choice
 Preference
of technique are discussed, and the European
Guidelines are used to demonstrate that standardi- Type of hernia
sation is indeed possible and recommended.  Indirect
 Direct
What is a standard technique? We know that  Combined
specialists such as Amid use a Lichtenstein tech-  Recurrence (prior technique?)
nique for almost all repairs. The same can be said  Femoral hernia
of other techniques such as Shouldice, Stoppa, and
Surgeon-related
endoscopic repair techniques. We, sadly, also know  Specialist in hernia centre
that many surgeons do not use the technique as  Specialist in general practice
described by the originator. »Choose the surgeon,  Laparoscopic surgeon
not the technique« is a known adagium. Is a »stan-  General surgeon (dedicated?)
dard« technique truly standard in most cases? And Resident
do surgeons who state that they use a standard
technique deviate from this standard in some (or
many) cases?
Before we can be pro standard technique, fac- Comorbidity: As with ASA class, some patients re-
tors influencing the possibility of stating this must quire a low-risk technique under local anaesthesia.
be identified. The type of hernia, type of patient,
type of surgeon, and the setting in which he or she Type of anaesthesia: Endoscopic surgery requires
operates are discussed (⊡ Table 62.1). general anaesthesia.

Preference: Although little data are available on


Patient-Related Factors this subject, nobody will contradict the fact that
some patients prefer a technique under local an-
Gender: Female patients have a higher rate of aesthesia whereas other patients request a mini-
chronic pain and a higher risk of femoral hernia. mally invasive technique.

Obesity: Morbidly obese patients require an indi-


vidualised approach. Type of Hernia

American Society of Anesthesiologists (ASA) The normal distribution (as measured in large
class: In many cases, ASA 3 and 4 patients have studies and national databases) of inguinal hernias
contraindications to general anaesthesia, preclud- is as follows:
ing the use of certain techniques. Indirect 50–55%
Direct 30–35%
Prior groin surgery: Prior groin surgery, prior Combined 10–15%
lower abdominal surgery, radiation, and other fac- Bilateral 10–15%
tors greatly influence the choice of technique. Recurrent 10–15%
Chapter 62 · In Support of a Standard Technique for Inguinal Hernia Repair
477 62

⊡ Table 62.2. Differences in hernia repair among countries

Types of inguinal hernia repair

Country Year Conventional Open mesh Endoscopic Other

Netherlands 2006 4% 78% 19%

Denmark 2006 2.5% 82.5% 15%

Finland 2006 7% 81% 8% 3%

France 2006 14.9% 46% 34% 4.6%

Poland 2006 38% 60% 1%

Austria 2006 76% 24%

Hungary 2007 60% 34% 6%

Sweden 2006 8.5% 82% 9%

The distribution shown precludes the use of one Is Hernia Surgery Standardised?
standard technique in inguinal hernia. It is a fact,
though, that around 70–75% of inguinal hernia Many techniques are being used, and the literature
repairs are for unilateral primary cases. For these shows that the differences among countries are sig-
cases, a standard approach (either by anterior or nificant (⊡ Table 62.2). There is a growing indica-
endoscopic approach) is feasible. tion that in European and North American coun-
But a standard »Lichtenstein surgeon« will tries, a majority of inguinal hernias are treated by
have difficulty treating a complex third recur- a Lichtenstein technique. Endoscopic repair varies
rent hernia after open techniques or bilateral large from 1% to 24%. Miscellaneous other techniques
recurrent hernias. A »laparoscopic surgeon« will are used in 5–20% of cases, but one could postulate
have difficulty when a patient specifically requests that these are standard procedures (for example,
an operation under local anaesthesia or has a dif- Prolene Hernia System, Kugel, plug-and-patch), as
ficult recurrence after prior preperitoneal repair. is the Lichtenstein.
In the Netherlands, guidelines in 2002 rec-
ommended a Lichtenstein repair (as a standard)
for unilateral uncomplicated inguinal hernia, an
Level of the Surgeon endoscopic repair for bilateral hernias (if the
expertise was available), and a tailored approach
Expert surgeons use a standard technique for most for recurrent hernias. An implementation study
cases and agree that surgeons need proficiency was performed. In 2001, all inguinal hernia sur-
in at least two techniques–preferably an anterior geries in 73 hospitals (70% of the total) were
technique and a posterior technique–to be able to analysed after 1 year of follow-up (charts only). A
treat all cases. few years after implementation of the guidelines
Laparoscopic surgeons will state that almost (2006), the study was repeated. Results are shown
all cases can be treated by laparoendoscopic tech- in ⊡ Table 62.2.
niques. But there are contraindications to these It is postulated that the increase in mesh (pre-
techniques, including previous lower abdominal dominantly Lichtenstein) has decreased the per-
surgery, radiation, prior mesh implantations, and centage of reoperations for recurrence from 14%
inability to undergo general anaesthesia. to 11%.
Guidelines advise teaching residents both ap-
proaches (anterior and posterior).
478 Chapter 62 · In Support of a Standard Technique for Inguinal Hernia Repair

What Do the European Guidelines in trials. Specific patient categories are not ran-
Recommend? domised, usually because they require a tailored
approach. O’Dwyer’s MRC trial is an example of a
62 Guidelines are developed to improve practice, es- study in which an endoscopic »standard« operation
pecially general practice. Those involved in devel- was compared with a »tailored open approach.« In
oping the European Guidelines have, after consid- the open group, around 20% of patients were oper-
ering the following factors, come to the following ated on with a nonmesh technique and 80% by a
recommendations regarding the following: Lichtenstein technique. There was no difference in
▬ Risk of recurrence recurrence after 2 years.
▬ Safety (risk of complications)
▬ Postoperative recovery and quality of life
(resumption of work) Conclusion
▬ Grade of difficulty and reproducibility (lear-
ning curve) After analysing the arguments discussed above,
▬ Costs (hospital and societal) this author concludes that an approach using one
standard technique for all inguinal hernias is not
Level A feasible. It is possible, though, to use one stan-
All male adult (>18 years) patients with a symp- dard technique for the 70–75% primary unilateral
tomatic inguinal hernia should be operated on cases. This can be an open mesh technique such
using a mesh technique. as Lichtenstein. Some patients will prefer an en-
When a nonmesh repair is considered, the doscopic approach! This can also be a »standard«
Shouldice technique should be used. endoscopic approach. Some patients will have con-
The open Lichtenstein and endoscopic ingui- traindications for this technique, and it cannot be
nal hernia techniques are recommended as best performed under local anaesthesia.
evidence-based options for repair of a primary Recurrent inguinal hernia requires an individ-
unilateral hernia, providing the surgeon is suffi- ualised approach with at least two and maybe even
ciently experienced in the specific procedure. three techniques, depending on prior technique
and patient factors.
Level D It is important to determine for which type of
For large scrotal (irreducible) inguinal hernias, surgeon how this situation should be handled. A
after major lower abdominal surgery, and when specialist surgeon will be used to individualising
no general anaesthesia is possible, the Lichtenstein treatment and will master different techniques. On
repair is the preferred surgical technique. the other hand, in a teaching hospital, surgeons
It is recommended that in the case of a re- and residents should start by teaching/learning
current inguinal hernia following an anterior ap- one »standard« technique well for uncomplicated
proach, a preperitoneal mesh should be placed, cases. This leaves 20–25% of the cases, such as bi-
preferably by means of an endoscopic technique. lateral hernias, recurrent hernias, female patients,
It is recommended that an anterior approach and young patients, for which dedicated or (sub)
be used in the case of a recurrent inguinal hernia specialised surgeons should be prepared to choose
that was treated with a posterior approach. between an open anterior or a posterior approach
Because evidence is scarce, a tailored approach is (author’s opinion). The posterior approach can be
recommended for female patients and young adults. performed endoscopically or via an open approach.
In certain cases, a mesh might not be necessary. Ev-
idence is unclear whether females and young adults
What Does the Literature Recommend? with an indirect primary hernia require mesh.

Most trials describe results between standard pro-


cedures, but there is, of course, an inclusion bias
63

In Support of Individual Selection


of Technique as Related to the
Patient–Improvement by Better
Selection of Patients Who Can
Be Offered a Less Risky Technique:
Groin Hernia
B. D. Matthews
480 Chapter 63 · In Support of Individual Selection of Technique as Related to the Patient–Improvement

Introduction toneal repair, and laparoscopic transabdominal


(TAPP) or total extraperitoneal (TEP) inguinal
Dr. David Sackett of McMaster University in On- hernia repair. Watchful waiting for asymptomatic
tario, Canada, defined evidence-based medicine or minimally symptomatic inguinal hernias is also
as the judicious use of the best current evidence in considered standard of care. Primary tissue repair
making decisions about the care of the individual is infrequently performed, but it is often done for
63 patient. He further remarked that evidence-based incarcerated and/or strangulated inguinal her-
medicine is a means to integrate clinical expertise nias when wound contamination is a concern.
with the best available research evidence and pa- A Cochrane Database review in 2001 reported
tient values. Clinical outcome research in surgery a 50% reduction in inguinal hernia recurrence
is commonly criticized for a lack of prospective when a tension-free repair was performed, pro-
randomized trials to compare alternative surgi- viding additional evidence of the shortcomings of
cal techniques or operative versus nonoperative primary repair [2]. Nevertheless, familiarity and
treatment when the option of avoiding surgical experience in primary tissue repair is important
intervention is considered appropriate. Despite when a surgeon is faced with an incarcerated and/
these shortcomings, there is perhaps no area in or strangulated hernia or unique circumstances
surgery in which more level I evidence is available when a mesh-based repair is deemed inappropri-
to guide clinical practice and surgical decision ate. A tailored approach to the individual patient
making than in the care of patients with inguinal using evidence-based medicine will allow for the
hernias. integration of surgical expertise and approach
Because the cumulative incidence of inguinal with unique patient characteristics. This chapter
hernias in males is approximately 14% at a median discusses important patient and surgeon variables
follow-up of 18.2 years, as reported in a recent to consider in order to optimize patient outcomes
publication from the first National Health and Nu- through selection of an appropriate technique
trition Examination Survey, the application of clin- for patients undergoing elective inguinal hernia
ical outcome studies to inguinal hernia patients is repair.
critical to guide surgeons toward appropriate care
of this common surgical problem [1]. Minimiz-
ing recurrent hernias, chronic inguinodynia, and Watchful Waiting Versus Inguinal
additional postoperative morbidities and decreas- Hernia Repair
ing postoperative recovery to facilitate a return to
self-reliance are paramount. Despite an enormous Upon initial evaluation of a patient with an in-
quantity of clinical outcome data comparing open guinal hernia, the surgeon must decide whether
tension-free to primary tissue repair techniques inguinal hernia repair is required. A doctrine that
and open tension-free to laparoscopic inguinal the presence of an inguinal hernia, even if asymp-
hernia repair, controversy persists regarding the tomatic, is an indication for repair to prevent an
use of a standard versus a tailored approach to the acute hernia emergency from incarceration and/
management of groin hernias. Patient care guide- or strangulation has been challenged by two re-
lines for inguinal hernia repair were published by cent prospective randomized trials. O’Dwyer et
the Society for Surgery of the Alimentary Tract in al. reported only one (1.3%) patient out of 78
2006 and the National Institute for Clinical Excel- who developed an acute incarceration at a median
lence for the NHS (United Kingdom) in 2004, but follow-up of 574 days [3]. The rate of crossover
they are vague in regard to the use of laparoscopic to inguinal hernia repair was 26% at 15 months.
inguinal hernia except for the need for appropriate Two patients in the observation group who subse-
training and experience in a minimally invasive quently underwent surgery suffered a myocardial
approach. infarction and cerebrovascular accident, respec-
Many techniques exist, including primary tis- tively. The authors concluded that observation
sue repair, open tension-free anterior or retroperi- may only delay surgical intervention. Neverthe-
Chapter 63 · In Support of Individual Selection of Technique
481 63
less, watchful waiting would be appropriate for a consequence, laparoscopic techniques account
high-risk patients since an acute hernia accident for only 20–30% of inguinal hernia repairs in
is quite rare. In a comparable study, Fitzgibbons the United States. Reasons to not perform lap-
et al. reported the frequency of acute incarcera- aroscopic inguinal hernia repair for a unilateral
tion to be 1.8 per 1,000 patient-years inclusive primary hernia include surgeon preference, lack
of patients followed for as long as 4.5 years [4]. of expertise in minimally invasive techniques,
The probability of crossover from watchful wait- complexity of the hernia (e.g., inguinoscrotal, in-
ing to inguinal hernia repair was approximately carcerate), and cost. Laparoscopic inguinal hernia
23% at 3 years of follow-up. Delaying repair of an repair is almost always performed under general
asymptomatic or minimally symptomatic inguinal anesthesia, certainly limiting its use. Ideally, all
hernia did not have adverse effects on subsequent patients would receive the treatment that provides
operative intervention or postoperative outcomes the most durable repair with the least amount of
[5]. Why would watchful waiting decrease patient perioperative morbidity (pain, quality-of-life limi-
morbidity? A population-based questionnaire in tations, and cardiac, pulmonary, and non-hernia-
the Netherlands of consecutive patients who un- related complications). Although a few risks as-
derwent inguinal hernia repair over 68 months sociated with hernia recurrence and even chronic
reported that 40.2% of patients had »some degree pain have been established, patient-specific and
of pain,« with 21% being confronted with some hernia-specific factors associated with postopera-
degree of limitation in daily functioning and 1.9% tive complications and hernia recurrences are be-
experiencing severe pain [6]. Therefore, due to a ing defined. There is a possibility that minimally
high incidence of chronic pain, watchful waiting is invasive techniques are underutilized or, alterna-
particularly relevant for patients with asymptom- tively, not performed in the appropriate patient.
atic or minimally symptomatic hernias. Even though the majority of inguinal hernia re-
pairs are day cases, risk stratification of periop-
erative morbidity in addition to recurrence and
Laparoscopic Versus Open Inguinal chronic pain after laparoscopic and open inguinal
Hernia Repair hernia repair would be useful in determining an
appropriate surgical approach.
Over 40 prospective randomized single-institution The Patient Safety in Surgery (PSS) Study, a
or multi-institutional studies comparing laparo- collaboration between the U.S. Department of Vet-
scopic (TAPP and TEP) inguinal hernia repair to erans Affairs (VA) National Surgical Quality Im-
open tension-free inguinal hernia repair have been provement Program and the American College of
reported worldwide. A recent review by Takata Surgeons and funded by the Agency for Healthcare
and Duh summarizing these publications dem- Research and Quality, took 97 different periopera-
onstrated that laparoscopic inguinal hernia repair tive variables (patient demographics, preoperative
has a beneficial role in decreasing chronic inguin- risk factors, preoperative laboratory values, op-
odynia and recurrence rates and is associated with erative values, and postoperative outcomes) and
shorter convalescence and a faster return to work cross-referenced them to the top 10 most frequent
and activities in patients with recurrent, bilateral, current procedural terminology (CPT) codes [9].
and primary inguinal hernias [7]. In a prospective In the VA system, open inguinal hernia repair (the
randomized trial of laparoscopic inguinal hernia 1st most common code), recurrent inguinal her-
repair and anterior tension-free repair for recur- nia repair (6th), and laparoscopic inguinal hernia
rent inguinal hernias, patients experienced less repair (8th) are represented. The PSS Study has
postoperative pain and fewer days of sick leave evolved to include private sector hospitals, with
after a laparoscopic approach. Cumulative 5-year open inguinal hernia repair being the 2nd most
recurrence rates were equivalent [8]. Indeed, lap- common CPT code. Because the aim of the PSS
aroscopic inguinal hernia repair is most often Study is to minimize postoperative morbidity and
performed for bilateral and recurrent hernias. As mortality and to risk-adjust adverse events for
482 Chapter 63 · In Support of Individual Selection of Technique as Related to the Patient–Improvement

common procedures in order to compare different ing into the widely developed preperitoneal space,
hospital systems, information on inguinal hernia or even intraabdominal bleeding, seems a poor
repair will allow surgeons to appropriately risk- choice compared with an anterior tension-free
stratify patients for open and laparoscopic inguinal repair in which postoperative bleeding could be
hernia repair. managed with less morbidity. As additional studies
Matthews et al. have identified risk factors are reported and risk stratification becomes more
63 associated with complications and recurrences reliable, surgeons will need to alter their operative
in patients undergoing laparoscopic and open approach to inguinal hernia repair to ensure that
inguinal hernia repair and have developed a risk- they reduce the risks of postoperative morbidity
assessment model for hernia recurrence using the and recurrence.
data from the VA Cooperative Studies Program One factor that has not been evaluated is lap-
trial that compared open and laparoscopic surgi- aroscopic inguinal hernia repair for a recurrent
cal techniques for tension-free inguinal hernia hernia in a patient who has undergone an ante-
repair [10]. Independent patient-specific and sur- rior tension-free preperitoneal inguinal hernia
gery-specific variables that predict postoperative repair. A strategy to repair a recurrent hernia by
complications and recurrence have been defined. an opposite approach from the index operation
Many predictors of complications (e.g., recur- is obscured when the preperitoneal space has
rent hernia, inguinoscrotal hernia) were similar been disturbed and used for mesh placement,
between open and laparoscopic inguinal hernia albeit by an anterior approach. Although laparo-
repair, although several variables (e.g., prostat- scopic transabdominal and extraperitoneal ingui-
ism, surgeon experience) differed based on the nal hernia repair can successfully be performed
surgical approach. Risk for recurrence after an after previous abdominal and/or pelvic surgery,
open inguinal hernia repair included a recurrent additional investigation of laparoscopic inguinal
hernia, preoperative activity level of the patient, hernia repair after the anterior placement of pre-
American Society of Anesthesiologists class, and peritoneal mesh needs to be done. In addition,
whether the hernia had enlarged recently. Using differentiation of whether laparoscopic transab-
regression analyses, Matthews et al. have also dominal and extraperitoneal inguinal hernia re-
developed predictive models for perioperative pair reduce hernia recurrences, chronic pain, or
outcomes. These models can be used to deter- perioperative morbidity has not been elucidated
mine an appropriate surgical approach for an through clinical trials.
individual patient to reduce the risk of recurrence Evidence is accumulating that experience is
and complications. important in determining outcomes with regard to
Additional studies have reported a predictive hernia recurrence, not only for laparoscopic ingui-
risk score for infection after inguinal hernia repair nal hernia repair but also for open inguinal hernia
as well as patient characteristics associated with repair [13, 14]. Anterior tension-free preperitoneal
an increased risk of postoperative hematoma fol- inguinal hernia repairs such as the Prolene Hernia
lowing herniorrhaphy. Pessaux et al. developed a System (Ethicon, Somerville, NJ, USA) and Kugel
global infection score (GIS) dependent on risk fac- (Davol, Cranston, RI, USA) repair require specific
tors for infection (age, obesity, and use of a urinary training and an awareness of preperitoneal anatomy
catheter) as determined by multivariate analysis and the nuances of mesh placement. Arbitrary case
from a database of 1,254 patients [11]. The use volumes have been projected to define the learning
of prophylactic antibiotics in patients with a high curve, but they do little to define appropriate train-
GIS and/or a laparoscopic inguinal hernia repair ing. Surgeons need to honestly assess their clinical
appears to be a better option in these patients. outcomes and level of technical expertise with any
Smoot et al. reported that preoperative Coumadin type of inguinal hernia repair and properly choose
usage was a significant risk factor for postop- an approach that places the patient at the least risk
erative hematoma [12]. Intuitively, a laparoscopic for perioperative technique-related complications,
inguinal hernia repair with the potential for bleed- recurrence, or chronic pain.
Chapter 63 · In Support of Individual Selection of Technique
483 63
Conclusions 12. Smoot RL, Oderich GS, Taner CB, et al. (2008) Postopera-
tive hematoma following inguinal herniorrhaphy: patient
characteristics leading to increased risk. Hernia 12:261–
A tailored approach to the individual patient with
265
an inguinal hernia integrates surgical expertise and 13. Neumayer L, Giobbie-Hurder A, Jonasson O, et al. (2004)
evidence-based medicine to optimize patient out- Open mesh versus laparoscopic mesh repair of inguinal
comes through the selection of an appropriate tech- hernia. N Engl J Med 350:1819–27
nique. As predictors of complications after open and 14. Wilkiemeyer M, Pappas TN, Giobbie-Hurder A, et al. (2005)
Does resident post graduate year influence the outcomes
laparoscopic inguinal hernia repair are more clearly
of inguinal hernia repair? Ann Surg 241:879–84
defined through large multi-institutional prospec-
tive registries, the frequency of chronic pain and
the incidence of recurrent inguinal hernias can be
reduced, and the relationships between outcomes Discussion
and patient comorbidities, hernia characteristics,
and surgeon experience will be revealed. Kurzer: Perhaps we should get away from saying
that recurrence is the only thing we are interested
in; some of us have alluded to that. I get patients
References who come to me and ask if it will last forever,
but they don’t really expect the lack of recurrence
1. Ruhl CE, Everhart JE (2007) Risk factors for inguinal hernia to last forever. You can’t just operate to get rid
among adults in the US population. Am J Epid 165:1154–
of recurrence at all costs, and maybe we have to
1161
2. Scott N, Go PM, Graham P, et al. (2001) Open mesh versus
take into consideration operations that are more
non-mesh for groin hernia repair [review]. Cochrane Data- likely to cause pain in certain patients. In English,
base Syst Rev (3):CD002197 they say that to the man who has a hammer, ev-
3. O’Dwyer PJ, Norrie J, Alani A, et al. (2006) Observation ery problem is a nail. Clearly, if you are a hernia
or operation for patients with an asymptomatic inguinal
surgeon, you can’t have just one hammer, and you
hernia: a randomized clinical trial. Ann Surg 244:167–173
4. Fitzgibbons RJ, Giobbie-Hurder A, Gibbs, JO et al. (2006)
have to have other tools to deal with other hernias.
Watchful waiting vs repair of inguinal hernia in mini- There are clearly different hernias, different prob-
mally symptomatic men: a randomized clinical trial. JAMA lems, different patients.
295:285–292. Schumpelick: Could it be that the hernia centers
5. Thompson JS, Gibbs JO, Reda DJ, et al. (2008) Does delay-
tend more in the direction of standard procedures
ing repair of an asymptomatic hernia have a penalty? Am
J Surg 195:89–93
and that the general surgeons who do [operate on]
6. Loos MJA, Roumen RMH, Scheltinga MRM, et al. (2007) some hernias take a tailored approach?
Chronic sequelae of common elective groin hernia repair. Kurzer: No, I do not think so… probably more the
Hernia 11:169–173 other way round. I think the general surgeons are
7. Takata MC, Duh QY (2008) Laparoscopic inguinal hernia
the ones who would go through life with just one
repair. Surg Clin North Am 88:157–178
8. Eklund A, Rudberg C, Leijonmarck CE, et al. (2007) Recur-
operation that they use for everyone. It’s perhaps
rent inguinal hernia: randomized multicenter trial com- not a bad thing, if the general surgeon has only one
paring laparoscopic and Lichtenstein repair. Surg Endosc procedure that he can do, as long as he recognizes
21:634–640 when he sees a patient who has something he can’t
9. Khuri SF, Henderson WG, Daley J (2007) The Patient Safety
deal with and as long as he is happy to send it to
in Surgery Study: background, study design, and patient
populations. J Am Coll Surg 204:1089–1102
someone who can. If he sees someone with a bilat-
10. Matthews RD, Anthony T, Kim LT, et al. (2007) Factors eral recurrence and he can only do a Lichtenstein,
associated with postoperative complications and hernia he sends that patient away to someone who can do
recurrence for patients undergoing inguinal hernia repair: a TEP; he doesn’t try to do it himself. I think that
a report from the VA Cooperative Hernia Study Group. Am
is important.
J Surg 194:611–617
11. Pessaux P, Lermite E, Blezel E, et al. (2006) Predictive risk
Schumpelick: Is it likely that someone who is not
score for infection after inguinal hernia repair. Am J Surg used to doing a TAPP or TEP will send the patient
192:165–171 away? I have seldom heard about that.
484 Chapter 63 · In Support of Individual Selection of Technique as Related to the Patient–Improvement

Deysine: I have a double experience. I worked at of strength—or divide the omentum with Ultra-
the Bellevue Hospital in New York, in a popula- cision or some device, make a small incision in
tion of malnourished alcoholics, and then I went the scrotum, and mobilize and remove the hernia
to work at the VA Hospital in Northport with a lot content. So this is a combination of imagination
of different people with different kinds of malnu- and expertise. The ultimate bottom line is that the
trition. And then I went to work in my neighbor- patient should not be harmed. Give the best for
63 hood, where the income is extremely high, and your patient; do whatever is best for him.
people usually eat very well and they exercise. Fitzgibbons: I think that is a very reasonable ap-
These are three different types of human beings; proach, individualizing to some extent, but, as you
they all are going to heaven but in different condi- said, not too far.
tions. So if you try to standardize and you use for Chowbey: In a strangulated inguinal hernia, we
everybody the same procedure, you are going to go transabdominal with a pneumoperitoneum, re-
find different results. Surgeons who came from duce the bowel, and look at the viability of the
New York Hospital, a very rich environment, and bowel. In a few situations where we were not sure
operated in Bellevue using the techniques they about the viability of the bowel, we did not mind
used at the New York Hospital were a disaster. leaving a small 5-mm trocar and putting in an
You have to have in your pocket two or three tech- optic and looking at the viability of the bowel after
niques you can use, and [you have to] analyze very a few hours under local or short sedation. If the
carefully the biology of the patient you are going bowel is not viable, just open the patient and do a
to deal with. resection. This way, you can extend your expertise
Chowbey: I think it is very important to under- to different degrees.
stand that the technique depends on the expertise
of the surgeon, a group of surgeons of a depart-
ment, who have developed an expertise in a par-
ticular technique of hernia repair. For example, in
our department, we do mainly TEP in the majority
of our patients. But at the same time, the group
should have a sense of responsibility where they do
not stretch their imagination too far, do not stretch
their technique too far so as to harm the patient.
So if there is a patient after a radical prostatectomy
and you find that TEP is going to be difficult, it is a
good idea to do an anterior approach.
Schumpelick: How important is the wish of the
patient when they come to you and say that they
want this technique? Today our patients are quite
well informed by newspaper and the Internet.
Chowbey: This will not happen in our situation.
When a patient comes to us, he only comes to us
for endoscopic technique because we are known
for his technique. So even when a patient comes
with a huge, obstructed hernia with half of the
omentum in the scrotum, it is our responsibil-
ity to modify our technique. For example, in this
particular situation, we would still do an extra-
peritoneal approach. We know it is irreducible;
either we do a TAPP and reduce the hernia and
then go extraperitoneally—because that is our idea
64

In Support of Standard Procedure


in Abdominal Hernia Repair
J. B. Flament
486 Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair

Introduction computed tomography (CT) scanning is very use-


ful to assess the dimensions of the defect, the
The incidence of incisional hernia (usually defined retraction of the lateral muscles of the abdominal
as a chronic postoperative defect of the abdominal wall, and the volume of the mushroom-like mass of
wall through which intraabdominal viscera pro- bowel exteriorized from the abdominal cavity [9].
trude beneath the skin). has been reported to be As a consequence of the extraabdominal pro-
as high as 11–13% of all laparotomies [1, 2]. Surgi- trusion of the viscera, the decrease in intraab-
cal repair is difficult in cases of large abdominal dominal pressure leads to general and local distur-
64 defects when the herniated viscera have »lost their bances. The recti and lateral muscles are infolded
right to reside« in the abdominal cavity; it must be because they have lost their midline insertion on
remembered that surgical repair of an incisional the linea alba. Wylie [10], as early as 1887, had un-
hernia has nothing in common with closure of derstood this, writing that »most operators entirely
a laparotomy. The weakening of the abdominal overlook the fact that the deep fascia which divides
wall and the consequences of decreased abdominal and forms the sheath of the recti muscles, and
pressure on diaphragmatic mobility and respira- unites in the median line to form the linea alba,
tory function are important factors [3]. Surgical is in reality the tendon of the transverse abdomi-
repair requires placement of a prosthetic mesh. nal muscles; that is the fascia, and not the recti
Without mesh, the recurrence rate is high and pro- muscles, which gives the abdominal walls their
hibitive because it may vary from 30% to 60% [1]. transverse strength.« The recti abdominis are sag-
Retromuscular prefascial placement of the mesh, ittalized, and flat lateral muscles (external oblique,
which we will describe as a standard procedure, internal oblique, and transversus) are retracted
has been proposed by Rives and used in our de- and become fatty and sclerotic. The skin is also
partment since 1966. Let us remember its basic involved in the abdominal wall disease: Trophic ul-
principles: cerations are often observed in large tumefactions.
▬ A macroporous mesh They are located over the midline and the apex of
▬ Placed in an extraperitoneal site the protrusion, resulting from the weakening of
▬ With fixation by transfixing stitches the subcutaneous cellular tissue and the flattening
▬ Under a tension sufficient to give normal of blood vessels due to visceral pressure [11].
physiology to the abdominal wall Perhaps more important are the respiratory
▬ With a good cosmetic result consequences related to the disappearance of the
normal contribution of the abdominal muscles and
Described as early as 1973 [3], this technique diaphragm in respiration [3]. These disorders must
was clearly demonstrated in 1977 in the French be evaluated by appropriate respiratory function
Encyclopedia of Surgery [4]. The drawings were tests in order to avoid a catastrophic postoperative
later reproduced in the first and second editions course. In some cases, the herniated organs have
of Chevrel’s Hernias and Surgery of the Abdomi- lost their »right to reside« in the abdomen, and
nal Wall [5]. They have also been reproduced by herniation cannot be reintegrated into the abdo-
Kingsnorth [2] and, with minor modifications, by men. These cases require specific preparation with
Wantz [6], Stoppa et al. [7], and Bauer et al. [1]. therapeutic preoperative pneumoperitoneum [12].
This technique is considered the gold standard for
repair of midline incisional hernias [8].
Clinical features are evident, and the diagnosis Preoperative Care
is obvious at the first look. The bulge is seen when
the surgeon asks the patient to push or cough, in- On initial contact with the patient, respiratory
creasing the abdominal pressure. Palpation identi- function must be assessed (history of smoking,
fies the edges of the musculoaponeurotic defect, cough, expectorations). Preparation includes respi-
but precise measurement of the defect’s dimensions ratory physiotherapy, withdrawal of tobacco, and,
may be difficult in very obese patients. Therefore, if possible, weight loss. In cases of hernias with
Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair
487 64
loss of domain, as evaluated by preoperative CT herniated organs are no longer able to reside in
scanning [9], the technique of preoperative thera- the abdominal cavity and cannot be reintegrated
peutic pneumoperitoneum is useful. Air is injected into the abdomen. In this situation, there are really
into the peritoneal cavity until the patients feels two abdominal cavities. This concept of a second
discomfort (scapular pain). The amount of air that abdominal cavity was first described by Rives et al.
can be injected during each session varies greatly in 1977 [4]. CT scanning gives a clear view of the
according to the patient, from half a liter to more protruded viscera compared to the volume of the
than a liter. These pneumoperitoneum sessions residual abdominal cavity [9].
are repeated every 2 or 3 days, and the patient is A general description of the procedure can be
monitored with X-rays (subdiaphragmatic air im- easily given looking at a transverse cross-section of
ages). With this technique, the patient’s tolerance the abdominal wall (⊡ Figs. 64.1–64.4) [12, 13]. The
to reintegration of the herniated viscera can be prosthesis is placed in the rectus sheath, in contact
assessed. The diaphragm is readapted to work in with the muscular fibers of the rectus muscle,
physiological conditions and is able to accept the between the muscle and its sheath. The posterior
postoperative increase in intraabdominal pressure. layer of the rectus sheath, strictly closed, prevents
any contact of the prosthesis with the bowel loops.
Lateral fixation by transfixing stitches, placed
Surgical Treatment through buttonhole stab wounds, prevents any
displacement of the prosthesis and recreates the
The objectives of the operation are to place a physiological tension of the lateral muscles of the
prosthetic material in the retromuscular prefascial abdominal wall [14].
space. The prosthesis must be sutured under ten- The direction of skin incision is chosen ac-
sion. We use transfixing sutures. This procedure of cording to the previous incision or to the major
fixation can lead to recuperation of lateral muscle axis of the tumefaction. We usually perform a large
function since the physiological tension lost be- resection of fat and skin (dermolipectomy or pan-
cause of the middle detachment of the muscle is niculectomy) since the hernial sac always adheres
reestablished. But when there is a risk of septic to the skin. In cases of cutaneous ulceration, the
complication (opening of an old abscess, acciden- resected area should be as large as possible, ex-
tal opening of the bowel), the use of a nonabsorb- tending well behind the zone of infected lymphatic
able mesh must be forbidden. reticulum [12]. After opening of the sac, adherent
In most cases of huge incisional hernias that bowel loops, which are often present (mainly in
we deal with, there is a loss of domain because the cases of multirecurrent hernia), must be freed.

⊡ Fig. 64.1. The posterior rectus


sheath is opened near the linea
alba to expose the posterior layer
of the rectus muscle. (From Chevrel
and Flament [13], with permission
from Elsevier)
488 Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair

The margins of the orifice must be carefully hematomas if injured. In this case, they may be li-
identified. Secondary orifices must be searched gated. The dissection must be pushed to the pubic
for carefully (usually, these are diagnosed on sag- symphysis medially and to the Cooper’s ligament
ittal three-dimensional CT scan reconstruction) laterally. Thus, stitches may be passed through the
and should be open; residual aponeurotic bands Cooper’s ligament. Such stitches are a trick that
extending from one margin to the other have no takes only a few seconds and prevents any slippage
structural value and cannot be used for repair. of the mesh that would lead to suprapubic recur-
When the abdominal cavity is free, by lib- rences. This dissection may be difficult in cases of
64 eration of bowel adhesions, the posterior rectus previous prostate or bladder surgery.
sheath is opened–either with a sharp knife or The peritoneal cavity must be closed before
electrocautery–near the linea alba, to expose the the mesh is implanted. In most cases, suturing of
posterior layer of the rectus muscle (Fig. 64.1). the fascial margins can be achieved when the pos-
The area of mesh insertion must be as large as terior rectus sheath has been correctly and widely
possible. Suturing the mesh to the margins of the freed. When fascial closure cannot be achieved, we
defect offers no guarantee and usually results in close the defect with a patch of absorbable mesh.
hernia recurrence because of lateral detachment Omentum, when present, can also be used to pro-
of the mesh. Accordingly, the mesh should extend tect viscera from any contact with the prosthesis;
widely beyond the limits of the myoaponeurotic the posterior surface of the omentum allows good
orifice. An overlap of at least 5 cm is necessary. peritonization, while its anterior surface offers a
The dissection of the retromuscular space is real- surface of granulation tissue that granulates into
ized with a swab or scissors. It is a blunt dissec- the prosthesis.
tion and bloodless because it runs in an avascular
space. The dissection must be pushed to the lateral
margins of the rectus muscle, easily recognizable Preparation of the Prosthesis
by the perforating branches of intercostal neuro-
vascular bundles [15] (⊡ Fig. 64.2). The choice of prosthesis is based on the physi-
Below the arcuate line there is no posterior cal and biological properties of the material to
layer of the rectus sheath, so the prosthesis will be be used. The ideal material must be a fairly open
placed in the so-called preperitoneal or properito- mesh structure so that a rapid fibroblastic re-
neal space (Retzius space medially, Bogros space sponse is able to invest the prosthesis, facilitating
laterally). The dissection must be careful because its insertion. The ideal material must also be light,
branches of the inferior epigastric artery cross with a certain degree of elasticity and suppleness;
the operative field and may cause postoperative elasticity allows the prosthesis to conform freely

⊡ Fig. 64.2. The dissection is pu-


shed to the lateral margins of the
rectus muscle, easily recognizable
by the perforating branches of
intercostal neurovascular bundles.
(From Chevrel and Flament [13],
with permission from Elsevier)
Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair
489 64
to the curvatures of the visceral sac. According neous fat is very thick (as is usually the case in our
to the classification given by Amid [16], we use patients). Each limb of the suture is passed through
either a type III (macroporous with microporous the abdominal wall separately, but through the
components; Mersuture) or a totally macroporous same buttonhole stab wound (⊡ Fig. 64.4). In some
prosthesis (Prolene). The force of the abdominal cases when the abdominal wall is not too fatty, an
pressure holds the prosthesis against the deep sur- ordinary stitch with a straightened needle, held
face of the muscle, achieving a sort of »suture by by a strong needle holder, may pass through the
apposition.« However, this pressure-induced ap- abdominal wall, from outside to the retromuscular
position is not sufficient to maintain the prosthe- space previously dissected; take a bite of the pros-
sis correctly during the first postoperative week. thesis; and pass again through the abdominal wall
Therefore, it is necessary to ensure solid peripheral from inside to outside. (It is interesting to note
suturing of the prosthetic material. Sutures are that a company, Gore & Associates, has designed
placed near the edge of the prosthesis; the two a »suture passer« for celioscopic use that is very
ends of a nonabsorbable stitch are passed through similar to a straight Reverdin needle.) So each
a fold (⊡ Fig. 64.3). stitch transfixes the abdominal wall twice, through
To pass the stitches through the abdominal a cutaneous buttonhole stab wound that will be
wall, we use a Reverdin needle when the subcuta- closed at the end of the procedure by a single cuta-

⊡ Fig. 64.3. Sutures are placed near


the edge of the prosthesis; the two
ends of a nonabsorbable stitch are
passed through a fold. (From Chev-
rel and Flament [13], with permissi-
on from Elsevier)

⊡ Fig. 64.4. Each limb of the suture


is passed through the abdominal
wall separately, but through the
same buttonhole stab wound.
(From Chevrel and Flament [13],
with permission from Elsevier)
490 Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair

neous stitch. The passage of each end of the stitch on the 3rd or 4th postoperative day. Antithrom-
through the muscle must be separated by at least boembolism measures must be used.
1.5 cm. If they are closer, the muscle fibers may be
cut by the knot, which may cause small lateral re-
currences. The surgeon stands on the opposite side Results
of the stitches he or she is placing. Doing so, he or
she has a better view of the retromuscular space, In a recent series of 693 nonabsorbable prosthetic
and the tailoring of the prosthesis is easier and repairs [18], the postoperative course was unevent-
64 more precise. The transfixing sutures are placed ful in 96.4% of the patients. Five patients died
clockwise along each semilinear line (Spiegel line) during the postoperative course, one from infec-
and at each extremity of the laparotomy. Twelve tion. Other deaths were from cardiac or respira-
stitches are usually enough, but in cases of huge tory causes. Superficial infection occurred in eight
incisional hernia, up to 21 stitches may be used. cases (1.2%). Deep infection occurred in nine pa-
The stitches are knotted on one side and then on tients, one being lethal, but in only one case did we
the other side of the laparotomy. have to remove the mesh.
The tailoring of the prosthesis is important: The long-term results were evaluated by careful
The sutures must be placed under tension. This follow-up. We observed 42 recurrences (6.7%),
fixation procedure allows recuperation of lateral which were often small lateral recurrences. Thirty
muscle function because the physiological tension of them were successfully treated, leading to a final
lost by midline detachment of the muscle is rees- good result of 98%.
tablished (remember Wylie!).
In epigastric incisional hernias, the upper part
of the prosthesis is placed between the rectus abdo- Discussion
minis anteriorly and the ribs and internal oblique
posteriorly. If there is a loss of substance due to Naturally, this technique, although in our minds
retraction of the very short muscular fibers in this the best, cannot be applied to all cases; other sites
location, the prosthesis may be fixed by a stitch of prosthetic implantation may be chosen on an
going around the rib on each side. The surgeon anatomical basis.
must be careful not to pass the stitch through the Intraperitoneal positioning of the prosthesis is
cartilage; that may cause postoperative pain. The easy, and some published studies report good re-
surgeon must also be attentive to cover the »fatty sults [19]. However, we do not believe that intra-
triangle« described by Conze et al. [17]. peritoneal implantation has any advantages, ex-
At the end of the procedure, we trim the ex- cept rapidity. Of course, the peritoneum rapidly
cess prosthetic tissue. Two close suction drains envelops the prosthesis and offers a good defense
are placed in contact with the prosthesis. Closure against infection without hematoma formation,
of the musculoaponeurotic layer in front of the but adhesions of the bowel loops to the prosthesis
prosthesis is always possible, thanks to the tension are frequent, thereby hindering intestinal transit
of the prosthesis. Two drains are placed beneath and rendering reintervention dangerous. We have
the skin. Dermolipectomy in the case of obese observed 17 cases of intraluminal migration of in-
patients, as already mentioned, may be done for a traperitoneal prosthesis, and similar cases have
much better cosmetic result. been reported in the literature [20]. When possi-
ble, interpositioning of the omentum between the
viscera and the prosthesis, as advocated by Rives et
Postoperative Care al. in 1973 [3], can provide protection against these
complications.
During the early postoperative period, respiratory Laparoscopic placement of a prosthesis is a
physiotherapy resumes as soon as possible. Aspira- variant of intraperitoneal placement. We think this
tion drains are monitored and are usually removed technique may be used for small hernias but that
Chapter 64 · In Support of Standard Procedure in Abdominal Hernia Repair
491 64
it is ineffective for large hernias because the pros- 9. Pourcher G, Deguelte S, Diaz Cives A et al.: Giant incisional
thesis cannot be placed under good tension due to hernias: a new criteria for evaluation and treatment. Her-
nia [submitted]
the pneumoperitoneum. This technique may be
10. Wylie G: Ventral hernia caused by laparotomy. Am J Obs-
dangerous because dissection of the intrasaccular tet 20:53, 1887
adhesions is difficult and may lead to bowel fistu- 11. Flament JB, Avisse C, Palot JP et al.: Trophic ulcers in giant
las. Finally, laparoscopic treatment cannot give a incisional hernias–pathogenesis and treatment. A report
good cosmetic result because it does not treat the of 33 cases. Hernia 1:71–76, 1997
12. Flament JB: Retro rectus approach to ventral hernia repair.
problem of excess skin. Oper Tech Gen Surg 6:165–178, 2004
Premuscular positioning of the prosthesis is an- 13. Chevrel JP, Flament JB: Traitement des éventrations de la
other option [21]. This technique consists of clos- paroi abdominale. In: Encyclopédie medico-chirurgicale.
ing the midline by reflected flaps of the interior Editions techniques. Techniques chirurgicales–appareil
digestif. Elsevier, Paris, pp 40–165, 1995
layer of the rectus sheath, this suture being rein-
14. Flament JB, Palot JP: Prosthetic of massive abdominal
forced by a large premuscular prosthesis, usually ventral hernia. In: Fitzgibbons RJ, Greenburg AG (eds)
Prolene. The problem with this technique is the Nyhus and Condon’s hernia (5th edn). Lippincott, Phila-
necessity of lifting a huge cutaneous flap, which delphia, 2002, pp. 341–365
may lead to long-lasting seromas. 15. Flament JB: Funktionelle anatomie der bauchwand. Der
Chirurg 5:401–407, 2006
16. Amid PK: Classification of biomaterials and their related
complications in abdominal wall hernia surgery. Hernia
Conclusion 1:15–21, 1997
17. Conze J, Prescher A, Klinger U, Saklak M, Shumpelick V:
We can say that the standard retromuscular prefas- Pitfalls in retro-muscular mesh repair for incisional hernia:
the importance of the «fatty triangle.» Hernia 8:255–259,
cial prosthesis can be applied in about 80% of the 2004
cases we are confronted with. But an abdominal 18. Flament JB, Palot JP, Lubrano D et al.: Retromuskuläre
wall surgeon must know other techniques to fix netplastik: Erfahrungen aus Frankreich. Chirurg 73:1053–
the 20% of cases in which a retromuscular prosthe- 1058, 2002
sis cannot be used. 19. Arnaud JP, Cervi C, Tuech JJ et al.: Surgical treatment of
post operative incisional hernias by intra-peritoneal inser-
tion of a Dacron mesh. Hernia 1:97–99, 1997
20. Flament JB, Avisse C, Palot JP et al.: Complications in in-
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65

In Support of Individualized Procedures


in Abdominal Wall Hernia Repair
M. Miserez, E. Peeters, F. Penninckx
494 Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair

Introduction
⊡ Table 65.1. Risk factors for hernia recurrence

This paper describes our algorithm for a tailored  Obesity


approach to patients with abdominal wall hernias,  Smoking
 Diabetes
excluding inguinal hernias. We believe that, even  Immunodeficiency (including cirrhosis, malnutrition,
more than in inguinal hernia repair, an individu- etc.)
alised approach is most appropriate for an optimal  Chronic cough
 Prostatic hypertrophy
outcome.  Constipation
Abdominal wall hernias include both ventral  History of abdominal aortic aneurysm
and incisional hernias. A ventral hernia is a pri-
mary abdominal wall hernia (e.g. epigastric, um-
65 bilical, Spigelian). Any hernia developing at the site tailoring the approach to the individual patient [1].
of a previous incision is referred to as an incisional Type 1 hernias (width <5 cm) can be described as
hernia. Many different factors (patient, hernia, sur- small, type 2 hernias (width 5–10 cm) as medium,
geon, economic) play a role in the choice of the type 3 hernias (width 10–15 cm) as large, and type 4
most appropriate surgical procedure for ventral hernias (width >15 cm) as giant [2]. The latter are
or incisional hernia repair. Patient factors include sometimes accompanied by a loss of domain in the
risk factors for hernia development or hernia re- abdominal cavity. Hernia width is more important
currence (⊡ Table 65.1), details on previous hernia than hernia length because the possibility for ap-
repair with respect to the plane of previous mesh proximation of the lateral edges of the hernia defect
implantations, symptoms at the time of presen- depends on this hernia width. Moreover, hernia
tation (e.g. incarceration), and the importance of width is often correlated with the length and thus
aesthetic aspects to the patient (e.g. postoperative with the overall hernia surface area. In determin-
bulge). Hernia factors include the size of the defect ing the hernia defect size in incisional hernia, the
and hernia sac, the location of the defect (e.g. paras- size of additional defects (e.g. Swiss-cheese defects)
tomal), and the presence of additional muscle dia- or eventual weaknesses or bulging over the entire
stasis or bulging around the defect. Surgeon fac- previous incision need to be taken into account
tors imply that the surgeon should ideally have when calculating the final defect size. Of course,
both open and laparoscopic expertise. Economic the preoperative hernia diameter needs to be veri-
aspects refer to the cost of the new generation fied intraoperatively, and the surgical strategy may
of meshes (including specially designed intraab- need to be modified as a result of this.
dominal meshes with antiadhesive properties and When a mesh is used for hernia repair in the
»megaporous« meshes with larger pores and mostly ventral abdominal wall, it can be placed anterior to
lower weight or density than the classical macropo- the abdominal wall muscles (onlay), between the
rous meshes) and the hospital costs associated with, fascia edges (inlay or interposition), or posterior
for example, the use of a laparoscopic procedure to the abdominal wall muscles [sublay if extrap-
(laparoscopic equipment, disposable materials). eritoneal and underlay or intraperitoneal onlay
mesh (IPOM) technique if intraperitoneal]. (See
⊡ Fig. 65.1). Most authors agree that the current
Classification and Definition gold standard in open mesh repair is the sublay
extraperitoneal repair popularised by Rives [3] and
In the absence of an ideal ventral/incisional her- Stoppa [4]. The main disadvantage of this tech-
nia classification and taking into account differ- nique is the extensive retromuscular dissection
ent hernia details (e.g. defect location, diameter necessary for implanting the prosthesis, which can
and surface area, patient habitus, risk factors), the lead to postoperative wound complications such as
Chevrel classification based on the location and hematoma and seroma formation.
width (transverse diameter) of the hernia defect Therefore, open onlay mesh repair, initially pop-
currently offers the simplest, easiest system for ularised by Chevrel [5], has been recently promoted
Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair
495 65

⊡ Fig. 65.1. Terminology of


mesh location for ventral/incisi-
onal hernia repair

again [6] and could be especially useful in locations important in large and giant hernias to avoid early
where the retromuscular plane is more difficult mesh migration (leading to an early hernia recur-
to dissect (e.g. semilunar line, subcostal). Although rence) or later bulging of the mesh with a bad
easier than the sublay approach, it has not gained aesthetic result and abnormal functioning of the
widespread acceptance because of the less physi- abdominal wall muscles during respiration. In this
ological localisation of the mesh, in which a high case, the sutured fascia acts as an extra buttress, and
intraabdominal pressure might push the mesh away a faster mesh ingrowth due to better contact with
from the fascia and could ultimately lead to early host tissue can be expected. This is referred to as
recurrence, especially in cases of inadequate fixation mesh augmentation. In cases in which the fascia
and/or overlap of the defect. Moreover, the exten- cannot be closed completely, the mesh is used (par-
sive subcutaneous dissection might result in subcu- tially) as a bridge between the fascia edges (»mesh
taneous seroma formation and wound dehiscence. bridging«; ⊡ Figs. 65.1 and 65.2). Whether closure of
Because of the immediate contact of the subcutis the posterior rectus sheath (above the arcuate line
with a large surface of foreign body material, mesh of Douglas) before sublay mesh implantation is an
infection is also more likely to develop [2]. High- important factor in preventing postoperative bulg-
level evidence in the literature, however, is limited, ing/herniation remains unclear. We prefer to close
and only a randomised controlled trial (RCT) with this posterior rectus sheath as much as possible in
onlay vs. sublay mesh positioning as a variable will order to create a barrier between the (polypropyl-
be able to solve this pertinent question. ene) mesh and the viscera and also to restore the
On the other hand, because of the absence of original anatomical planes as much as possible.
any overlap between mesh and healthy tissue, and
thus a high risk for hernia recurrence, inlay repair
should be abandoned. Very Small Ventral or Incisional Hernias
In both open onlay and sublay mesh repair, (≤2 cm Maximum Diameter)
special attention should be paid to closing the ante-
rior fascia by adapting the abdominal wall muscles The data in the literature on the value of primary
and anterior rectus sheath on the midline. This suture repair in small ventral or incisional hernias
reconstruction of the abdominal wall is especially are very limited. Two RCTs are available. The
496 Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair

65

⊡ Fig. 65.2. Anatomical de-


monstration of mesh augmenta-
tion techniques and inlay mesh
positioning

first trial compared the long-term recurrence rate A subanalysis showed a recurrence rate of 10%
of a continuous suture repair (polypropylene) vs. (suture) vs. 0% (mesh) in the very small hernias
sublay polypropylene mesh repair in 181 midline (≤3 cm) and a recurrence rate of 13% (suture)
incisional hernia patients (diameter ≤6 cm) [7]. A vs. 3% (mesh) in the larger hernias (>3 cm) [9].
subanalysis of small incisional hernias (hernia sur- Complications in the overall group did not differ.
face area ≤10 cm2) showed a significantly increased Also in this paper, no data are given with respect
10-year cumulative recurrence rate of 67% vs. 17% to body mass index (BMI) or other risk factors for
for the suture repair patients (p=0.003). The overall hernia recurrence.
long-term complication rate (small and larger her- Thus, although the recurrence rate in the
nias), which was available for 126 patients with an small hernias is clearly in favour of mesh repair in
average follow-up of 8 years, showed no significant both trials, it is not entirely clear that both groups
difference (8% for suture repair vs. 17% for mesh were comparable concerning risk factors for de-
repair; p=0.17). However, six patients in the mesh veloping a recurrent hernia. Moreover, it is not
group developed a fistula between the mesh and certain whether the data for these small hernias
the skin (n=3), a mesh infection (n=1), or an en- with a diameter of around 3 cm (surface area of
terocutaneous fistula (n=2). Further details on the 10 cm2= diameter of 3.6 cm, provided the defect
association between hernia defect and complica- is circular) are valid for even smaller hernias
tion rate are not available. The authors concluded with a maximum diameter the size of a finger
that suture repair should be abandoned. (1.5–2 cm), this being the majority of umbilical
Another RCT compared the long-term recur- hernias. Therefore, also taking into account the
rence rate (mean follow-up 64 months) after suture chronic risk of mesh-related complications [10],
repair (interrupted nonresorbable suture) vs. sub- in the absence of any risk factors and without
lay mesh repair (polypropylene mesh or plug) in muscle diastasis around the defect, we suggest
primary umbilical hernia patients [8]. Here, too, a suture repair for very small ventral (umbili-
the recurrence rate was significantly increased in cal, epigastric, Spigelian) or incisional hernias
the suture repair patients (11% vs. 1%; p=0.0015). (e.g. trocar site hernias).
Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair
497 65
After all of the avascular weakened scar tissue methods of follow-up. To answer these questions,
is excised, the suture repair should preferably be a large RCT was initiated both in Europe and the
performed with a one-layer nonabsorbable mono- United States. It seems that the trial in the United
filament suture of size 0 or 1, or slowly resorbable States, comparing open onlay repair and laparo-
polydioxanone. Transverse adaptation of the fascial scopic repair, was prematurely stopped because of
edges without a »vest-over-pants« Mayo technique an unacceptable number of wound complications
[11] is suggested. in the open group [14]. The European LAPSIS
trial, running under the auspices of the European
Hernia Society, currently includes more than 200
Small and Medium-Size Ventral/ patients and compares not only open sublay re-
Incisional Hernias (2–10 cm Maximum pair vs. laparoscopic repair but also, in every arm,
Hernia Width) the use of a biological mesh (Surgisis Gold) vs. a
nonresorbable prosthesis. Inclusion criteria are pa-
For these hernias we suggest an open sublay or tients with a BMI <40 and a primary or incisional
laparoscopic IPOM mesh repair. In a retrospective hernia with a maximum diameter of 4–10 cm. All
analysis of 175 consecutive patients with open sub- eligible patients in our department have been pro-
lay repair and average hernia size between 8.5 cm posed to enter the trial. The primary end point is
and 10.6 cm, anterior fascial closure was associ- a composite end point of major complications at
ated with a decreased risk for prosthetic infection 3 years (hernia recurrence and/or mesh infection
(2% vs. 26%; p<0.01). The recurrence risk after and/or reoperation related to the previous hernia
a follow-up period of 20 months was not shown repair) [15].
to be statistically different, although recurrence For all patients with a very small hernia who do
rates were increased by almost threefold in the not undergo suture repair and for all other patients
nonclosure group (16%) vs. the closure group (6%; with a maximum hernia width of 10 cm that do
p=0.10) [12]. With adequate mobilisation of the not fulfil the inclusion criteria for the LAPSIS trial,
skin and subcutis laterally, anterior fascial closure either a laparoscopic or an open sublay mesh re-
is almost always possible in these hernias during pair can be offered. In the absence of further high-
open sublay repair. When a small gap remains, the level evidence-based data, we propose laparoscopic
medial edges of the anterior rectus sheath can be repair to the patient, especially in cases of BMI
fixed onto the mesh, or a small polyglactin mesh >35–40, on the condition that he or she be willing
can be used as an additional inlay mesh to avoid to cover the additional cost for the intraabdomi-
lateral retraction of these edges. nal prosthesis since these costs are currently not
Laparoscopic mesh repair has the main advan- covered by the social security system in Belgium.
tages of decreased wound complications, especially In a specific subgroup of these patients, we try to
in obese patients, and a shortened hospital stay avoid the use of an intraabdominal prosthesis by
[13]. On the other hand, a laparoscopic repair in- using an endoscopic totally preperitoneal repair,
volves the use of a more expensive intraabdominal as in laparoscopic totally extraperitoneal (TEP)
antiadhesive mesh, and both postoperative acute inguinal hernia repair [16]. Good candidates for
and prolonged pain may be higher after a laparo- this technique are patients with a lateral incisional
scopic procedure. All of these parameters should hernia (e.g. postappendectomy) or a hernia that is
be taken into account when calculating cost-effec- localised subxiphoidally, suprapubically, or close
tiveness. Recurrence rates in the midterm seem to to other bony edges (iliac spine, costal margin). In
be comparable with those for open repair. How- many cases, direct contact between the mesh and
ever, from the available randomised trials so far, the bowel can be avoided, and a simple polypro-
it is very difficult to draw any final conclusions pylene mesh is used.
because of the low patient numbers and the het- Ideally, anterior fascial closure and mesh aug-
erogeneity of inclusion criteria, definitions of post- mentation should also be aimed at during a lap-
operative outcome parameters, and duration and aroscopic procedure, not to decrease the risk for
498 Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair

prosthetic infection as in open repair but mainly to tioned before. The most radical relaxing incision
decrease the risk for early mesh migration or late technique is the component separation technique
bulging of the mesh. We believe this is especially (CST) described by Ramirez et al. in 1990 [23].
true for the large and giant hernias, but it is exactly Another possibility is multiple small relaxing in-
in this group of patients that this is most difficult to cisions bilaterally on the anterior rectus sheath
accomplish due to excessive tension on the tissues, according to Clotteau and Premont [24] or one
even after decreasing the intraabdominal pressure single relaxing incision on each anterior rectus
of the pneumoperitoneum. Chelala et al. described sheath two-thirds from the midline according
excellent results (low incidence of seroma forma- to Gibson [25], with or without turndown of the
tion and chronic pain, low recurrence rate) in a anterior rectus sheath according to Welti and Eu-
large group of patients with systematic laparo- del [26]. If, however, a large defect remains at the
65 scopic closure of the defect (although no closure level of the anterior fascia (mesh bridging), most
was performed in 4.5% of cases), but it is not clear authors also agree that a so-called megaporous
how many patients actually had a large defect mesh should preferably be avoided to decrease
[17]. Whether this closure really needs to be done the risk for early or late bulging of this type of
in small and medium-size hernias remains to be soft, (too) elastic prosthesis.
shown [18].
In all cases, exploration of the complete scar
is warranted, and additional hernias or bulging or Giant Ventral/Incisional Hernias
diastases over a previous incision need to be ad- (>15 cm Maximum Hernia Width)
dressed and treated as the original hernia. In the
absence of any weaknesses, we use a tailored ap- This group of patients present with the most chal-
proach based on different parameters to determine lenging hernias. For the same reasons as discussed
the need for coverage of the whole incision in a above, we believe laparoscopic repair is not indi-
patient with an incisional hernia [19]. cated. In the case of loss of domain in the abdomi-
nal cavity, a preoperative pneumoperitoneum [27]
and optimal preparation of the patient (e.g. weight
Large Ventral/Incisional Hernias loss, respiratory physiotherapy, bowel preparation)
(10–15 cm Maximum Hernia Width) may be necessary. Especially in this patient group,
in whom anterior fascial closure is important for
Although a laparoscopic approach is feasible [20, an acceptable functional and aesthetic result, this
21], we feel that a low chance for recurrence, to- closure is at the same time the most challenging,
gether with an optimal functional and aesthetic due to retraction of the fascial edges laterally, and
result, can be obtained only by an open sublay CST is necessary in the majority of cases.
repair with excision of redundant, often thinned Skin coverage with a well-vascularised skin
compromised skin and a maximal attempt at ana- and subcuticular flap without undue tension is
tomical reconstruction of the abdominal wall. In extremely important in this group to avoid wound
addition, (laparoscopic) adhesiolysis can be very dehiscence or superficial wound infection, which
cumbersome in large and giant hernias, and the might be the start of a real disaster, with mesh
mortality rate in cases of unrecognised enterotomy infection and fascia disintegration. Therefore, all
can be as high as 7.7% [22]. compromised skin tissue of bad quality needs to
In most smaller hernias during open repair, be excised at the end of the procedure. An exten-
the anterior fascia can readily be approximated sive lateral dissection together with adequate sub-
on the midline, but in these larger hernias, ad- cutaneous drainage and avoidance of dead space
ditional relaxing incisions may be necessary to on the midline are key points to preserve skin
obtain this goal. Apart from decreasing the risk integrity at the incision during the postoperative
for prosthetic infection, this adaptation is mainly course. To do this, a multidisciplinary approach
important in large and giant hernias, as men- involving the plastic surgeon to create an autolo-
Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair
499 65
gous skin (plus fascia) flap is necessary in a subset patient population reported on by Kingsnorth et al.
of these patients. [6]. In such cases, it is possible to overlap the relax-
Due to a small part of the rectus muscle that ing incisions with the same mesh, extending far lat-
remains, it is nearly always necessary to open the erally and thereby reducing the risk for abdominal
semilunar line to develop a nice extraperitoneal wall bulging or even abdominal wall rupture [31].
plane (beneath the transversus abdominis muscle)
for mesh implantation; even then, it is almost im-
possible to close the posterior rectus sheath as a bar- Conclusion
rier between the mesh and the viscera, so a specially
designed mesh with antiadhesive properties will The algorithm in ⊡ Fig. 65.3 summarises our cur-
be needed. Whether a simple and cheap polygla- rent approach based on the maximum hernia
ctin mesh acts as an equally effective antiadhesive width. Of course, this algorithm is only a rough
barrier between polypropylene and the viscera re- guide to quickly determine the best approach. Pre-
mains controversial [28, 29]. In addition, Petersen operative patient details (including the skin condi-
et al. showed that extraperitoneal mesh implanta- tion, such as thinning or ulceration) and intraop-
tion might even further compromise anterior fascial erative hernia characteristics (especially in cases
closure, in contrast to intraperitoneal mesh implan- of unexpected multiple hernia orifices at different
tation [12]. Taking all of these findings together, locations) will influence the surgical strategy in the
a more straightforward intraperitoneal (underlay) individual patient. Therefore, we strongly believe
mesh implantation without extraperitoneal dissec- that the abdominal wall surgeon should master
tion might be a better option in these patients [30], both laparoscopic and different open procedures
despite the inherent risks of a more extensive adhe- in order to use them in a tailored way in the in-
siolysis. A third option is an onlay mesh technique dividual patient who presents with a ventral or
in combination with CST, as was done in 18% of the incisional abdominal wall hernia.

⊡ Fig. 65.3. Algorithm for determining surgical strategy as a function of hernia width in ventral/incisional hernia repair (CST
component separation technique)
500 Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair

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toneal ventral hernia repair. Surg Endosc 16:1207–1213
1. Chevrel JP, Rath AM (2000) Classification of incisional 17. Chelala E, Thoma M, Tatete B, Lemye AC, Dessily M, Alle
hernias of the abdominal wall. Hernia 4:7–11 JL (2007) The suturing concept for laparoscopic mesh
2. Korenkov M, Paul A, Sauerland S, Neugebauer E, Arndt fixation in ventral and incisional hernia repair: mid-term
M, Chevrel JP, Corcione F, Fingerhut A, Flament JB, Kux analysis of 400 cases. Surg Endosc 21:391–395
M, Matzinger A, Myrvold HE, Rath AM, Simmermacher RK 18. Agarwal BB, Agarwal S, Gupta MK, Mishra A, Mahajan
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Chapter 65 · In Support of Individualized Procedures in Abdominal Wall Hernia Repair
501 65
Discussion

Kurzer: Dr. Flament, have you ever seen a hernia


that you thought was inoperable, that you couldn’t
operate on?
Flament: Yes. There are some people—old patients,
with fistula and a short life expectancy; in these
cases we do not operate. But in young patients
with loss of domain, we perform a progressive
pneumoperitoneum; we could always reintegrate
all of the abdominal cavity. And in very rare cases
we perform a resection, for example, a left hemi-
colectomy to close the abdominal wall.
Deysine: A comment on the small hernias below
2 cm, which are most common. My experience
at the VA Hospital doing these little hernias with
conventional suture repair was a recurrence rate
of 100%. The motion of the abdominal wall when
the patient stands up is so strong that it will break
it. Since I began using small pieces of mesh, some-
times the tip of a plug, just to obliterate those little
holes, the recurrences went away.
Schumpelick: Maybe this should be studied in a
trial. I also believe that small trocar hernias can be
done by stitches with good results.
66

In Support of Standard Procedure


in Hiatal Hernia Repair
P. K. Chowbey, T. Mittal, V. Soni, R. Khullar, A. Sharma, M. Baijal, A. Dey
504 Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair

Introduction hiatal hernia repair on recurrence rate and side ef-


fects during long-term follow-up.
Laparoscopic esophageal surgery has gained pop-
ularity due to the unprecedented view it allows of
esophageal hiatal hernias and the ease of access to Materials and Methods
the surgical site offered by the minimal-access ap-
proach. Numerous series have demonstrated the Patients
safety and efficacy of approaching gastroesopha-
geal reflux disease (GERD) and hiatal hernia A total of 430 patients (165 men and 265 women)
repair laparoscopically [1, 2]. Despite increasing underwent laparoscopic hiatal hernia repair be-
experience with laparoscopic hiatal hernia repair, tween January 1994 and December 2007 at Sir
authors continue to report recurrence rates of Ganga Ram Hospital, Delhi, India. Their mean age
up to 43% with sutured cruroplasty [3, 4]. This was 42.4 years (range 25–72 years). In the period
66 compares laparoscopic hiatal hernia repair poorly between 1994 and 2002, suture cruroplasty was
with open repair, as it is well documented that performed for most of the patients with hiatal her-
open hiatal hernia repair with the addition of nias, except for those with a very wide hiatal defect
Stamm gastrostomy is associated with very low in whom the crura could not be brought together
recurrence rates [5, 6]. Additionally, intrathoracic with sutures. In those patients, mesh cruroplasty
wrap migration rates of up to 26% have been re- was performed. After 2002, crural repair was re-
ported for patients undergoing laparoscopic fun- inforced by using a mesh for hiatal hernias (>5 cm
doplication with primary sutured hiatal hernia hernial defect) as routine practice.
repair [7].
Some possible patient-related and procedure-
related mechanisms for recurrence include inap- Preoperative Investigation
propriate patient activity immediately after sur-
gery, inadequate excision of the sac, inadequate Preoperative evaluation included a chest X-ray,
mobilization of the esophagus, inadequate crural upper gastrointestinal endoscopy, and barium
closure secondary to widely spaced crura sutured swallow for all patients. Manometry and 24-h pH
under tension, and postoperative rupture of the monitoring were not routinely performed. Fluoro-
cruroplasty due to continuous excursion of the scopic evaluation provided a reasonable measure
diaphragm. of esophageal motility. The presence or absence
Several technical details have been considered of dysphagia was considered another reasonably
to minimize these high recurrence rates, including sound predictor of whether the patient would tol-
excision of the sac with complete detachment of erate full fundoplication. An antireflux procedure
the sac from the hiatus and mediastinum, adequate was performed in most circumstances.
mobilization of the esophagus with a minimum
of 3 cm of intraabdominal esophagus, and the use
of mesh cruroplasty in patients with large hiatal Indications for Surgery
hernias. The purpose of using prosthetic materials
is to achieve a tension-free hiatal repair. The mesh Sliding hernia: All symptomatic patients
may be used to close the gap between two widely
spaced crura or to reinforce a suture cruroplasty. Paraesophageal hernia: Even asymptomatic pa-
There has been debate regarding the type, size, tients were operated on to avoid the potential risk
and shape of mesh and the technique of mesh of life-threatening complications such as incar-
placement; these are matters of future research in ceration, volvulus, perforation, and bleeding.
this field.
The aim of the present study was to evaluate Exclusion criteria: Patients with symptoms of
the effect of mesh reinforcement in laparoscopic GERD without hiatal hernia
Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair
505 66
Surgical Technique Ports
The camera port (10 mm or 5 mm) is made above
Our aims of surgery are as follows: the umbilicus, one-third of the distance between
▬ Reduction of contents the umbilicus and the epigastrium toward the left
▬ Excision of the sac of the midline. Additional ports, three 5-mm and
▬ At a minimum, a 3-cm intraabdominal length one 10-mm, are placed as shown in ⊡ Fig. 66.2. The
of esophagus 5-mm port in the epigastrium is used to retract the
▬ Division of the short gastric vessels to mobi- left lobe of the liver using a Nathanson liver retrac-
lize the gastric fundus tor (our preferred method). In some cases we also
▬ Tension-free sutured crural repair in a hiatus use a fan retractor for retraction of the liver. The
<5 cm wide 5-mm port in the right midclavicular line and the
▬ Prosthetic repair of the crural gap in a hiatus 10-mm port in the left midclavicular line are the
>5 cm wide surgeon’s left-hand and right-hand working ports,
▬ A short, floppy 360° wrap respectively.

Anesthesia Reduction of Contents


The procedure is performed under general anes- With the use of atraumatic bowel graspers, the
thesia with endotracheal intubation. stomach is grasped and retracted, and the contents
from the hernial sac are then reduced (⊡ Fig. 66.3).
Position
The patient is placed in reverse Trendelenburg Excision of Sac
position with the knees slightly flexed. The sur- A right diaphragmatic crus is identified after di-
geon stands between the patient’s legs. The camera viding the gastrohepatic ligament (⊡ Fig. 66.4), pre-
assistant is positioned to the right of the patient serving the hepatic branch of the vagus in most
and the assistant surgeon to the left of the patient cases. Ultrasonic coagulating shears (UltraCision;
(⊡ Fig. 66.1). Ethicon Endo-Surgery, Cincinnati, OH, USA) are

⊡ Fig. 66.1. Operating theater


layout
506 Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair

66
⊡ Fig. 66.4. Gastrohepatic ligament being divided to visualize
the right crus

⊡ Fig. 66.2. Port positions


Esophagus Mobilization
Circumferential esophageal mobilization is done
using ultrasonic shears so as to have a minimum of
3 cm of intraabdominal esophagus around which
the fundal wrap is created. In our experience, it has
been possible to mobilize the esophagus to achieve
an intraabdominal length of 3 cm in all cases, and
we have not felt the need to perform an esophageal
lengthening procedure.

Division of Short Gastric Vessels


The short gastric vessels are divided to mobilize the
gastric fundus, using ultrasonic coagulating shears,
until the left crus is identified (⊡ Fig. 66.5). This
helps us in creating loose, floppy fundoplication.

⊡ Fig. 66.3. Stomach being reduced from mediastinum using Cruroplasty


bowel grasper The retroesophageal window is enlarged, and then
the esophagus is retracted to the patient’s left with
a sling made with a Penrose drain or umbilical
used to divide the peritoneum at the anterolateral tape. The size of the hiatus is then assessed in the
edge of the hiatus. The natural tissue plane that anterior–posterior plane (⊡ Fig. 66.6).
exists between the peritoneal and pleural layers of If the size of the hiatus is <5 cm, a primary
the hernial sac is developed, and the sac is sepa- posterior suture cruroplasty is performed using
rated completely. Once the complete dissection of two or three intracorporeal sutures (2-0 Ethibond;
the sac has been performed, the sac is excised close Ethicon, Somerville, NJ, USA) for crural approxi-
to its attachment to the gastroesophageal junction mation. Sutures are tied loosely so as not to stran-
and removed so that it does not interfere with sub- gulate the muscle fibers. A sufficient gap is left
sequent repair. between the crura by visual impression to allow
Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair
507 66

⊡ Fig. 66.5. Greater curvature of the stomach being mobilized ⊡ Fig. 66.7. 2–0 Ethibond suture being used to fix the crural
by dividing the short gastric vessels using ultrasonic coagu- soft mesh near the right crus
lating shears

⊡ Fig. 66.6. The size of the hiatus is assessed in the anterior– ⊡ Fig. 66.8. Gastrogastric suture with 2–0 Ethibond for fundal
posterior plane wrap

passage for a food bolus and thereby prevent dys- There has been concern about using polypropylene
phagia. We prefer to err on the side of a wider hia- mesh because it causes dense fibrosis, so later we
tus in place of tight closure. Tight closure may lead started using lightweight meshes, UltraPro (Ethi-
to intractable dysphagia, which might not respond con) and CruraSoft (Bard, Murray Hill, NJ, USA).
to any other measure and may need reexploration The CruraSoft is a V-shaped mesh that conforms
and removal of sutures. to the hiatal anatomy. The mesh is fixed using 2-0
If the size of the hiatus is >5 cm, a mesh repair Ethibond (Ethicon) sutures (⊡ Fig. 66.7), with its
is performed either to reinforce a sutured repair margins overlapping the crural margin by 2–3 cm.
or to bridge the gap between the widely spaced The gastric fundus is wrapped around the
crura. lower esophagus to create a tension-free wrap.
Before placing the mesh we prefer to approxi- Two gastrogastric seromuscular sutures are placed,
mate the crura posteriorly as much as can be which include a seromuscular bite on the esopha-
achieved without tension. In our initial practice, geal wall to ensure correct positioning of the fun-
we used polypropylene mesh (Prolene; Ethicon). doplication and prevent slippage (⊡ Fig. 66.8). We
508 Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair

routinely perform Nissen 360° fundoplication in cruroplasty group were lost to follow-up. There
most patients, but in patients with a history of dys- was no conversion to open surgery.
phagia, detected motility disorder, and age >65, we
perform partial fundoplication.
Intraoperative Considerations

Postoperative Management The intraoperative complication rate was 5.81%


(25 patients). Ten (2.32%) patients had a pleu-
Postoperatively, patients are kept on a liquid diet ral tear, which was managed by positive pressure
on the1st postoperative day and gradually started ventilation during carbon dioxide desufflation to
on a soft diet, progressing to a normal diet as tol- ensure lung expansion. There were no postop-
erated. They are advised to chew their food well erative sequelae. Ten (2.32%) patients had bleeding
and not to take large bites. All tablets are given in from the short gastric vessels, which was managed
66 a crushed form. We do not routinely recommend by the application of clips, and in five (1.16%) pa-
a Gastrografin study before starting a diet for the tients there was splenic capsule laceration, which
patient. was managed by compression. No splenectomy
Follow-up evaluations took place at 7 days, was required in any of our patients. In all patients,
3 months, and 1 year after surgery. A barium swal- an adequate intraabdominal length of esophagus
low was performed at 3 months and 1 year after was achieved by mobilizing the esophagus. No
surgery. Endoscopy was suggested for routine fol- patient required a gastroplasty.
low-up but was refused by most of our patients in The postoperative morbidity was 2.7%
view of the invasiveness of the procedure. However, (12/430). Three (0.06%) of our patients developed
it was done if the patient became symptomatic. complete dysphagia (inability to swallow saliva).
All of these patients were managed conservatively
on intravenous fluids and cessation of all oral in-
Surgical Outcome take. Five (1.16%) patients developed atelectasis,
and four (0.9%) had pneumonia that responded
Preoperative data were collected retrospectively. to intravenous antibiotics and chest physiotherapy.
Long-term follow-up assessment was prospectively There was no mortality. The mean duration of
performed for 410 patients (95%) using a stan- hospitalization was 3.2 days (range 2–9 days).
dardized questionnaire. Hiatal hernia recurrence Postoperatively, patients with suture cruro-
was assessed using barium swallow .The mean plasty had a dysphagia rate of 9.9% (34 patients
follow-up period was 5.6 years (range 1–13 years). out of 342) compared with 14.7% (10/68) in the
mesh cruroplasty group at 3 months after sur-
gery (p=0.344). However, the dysphagia rate at the
Statistical Analysis 1-year follow-up had improved in both groups and
was not significantly different between the groups
Statistical analysis was performed using, as appro- (3.8% vs. 4.4%; p=0.916). (See ⊡ Fig. 66.10.)
priate, a chi-square test and Fisher’s exact test. A p- Radiologic follow-up evaluation showed a
value <0.05 was considered statistically significant. hiatal hernia recurrence rate of 14.9% (51/342)
in patients with suture cruroplasty (⊡ Fig. 66.11).
Of these 51 patients, 12 were symptomatic. They
Results were initially managed medically; however, three
of these 12 patients required redo surgery. In all
In 357 patients we repaired the hiatus with sutured three patients, we found a hiatal disruption with
cruroplasty and in 73 patients with mesh cruro- intrathoracic migration of the fundal wrap.
plasty (⊡ Fig. 66.9). Fifteen patients in the sutured During follow-up of mesh cruroplasty patients,
cruroplasty group and five patients in the mesh the recurrence rate was 5.8% (4/68; ⊡ Fig. 66.12)
Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair
509 66

⊡ Fig. 66.9. Total number of patients undergoing hiatal hernia


⊡ Fig. 66.11. Recurrence rate in the suture cruroplasty group
repair with and without mesh

⊡ Fig. 66.10. Incidence of dysphagia in patients with suture


⊡ Fig. 66.12. Recurrence rate in the mesh cruroplasty group
cruroplasty at 3 months and 1-year follow-up

compared with 14.9% in the suture cruroplasty Discussion


group (p=0.071). All of these patients had a small
sliding hernia on radiologic evaluation. These pa- The past 50 years have witnessed a paradigm shift
tients were asymptomatic and are being regularly in the surgical repair of both inguinal and ventral
followed up. Most of these recurrences (three out hernias. Several reports of randomized data show
of four) were observed in the earlier patients. a clear superiority of tension-free mesh hernia re-
Since 2005, there has been no recurrence during pair for both inguinal and ventral hernias [8–10].
follow-up. Creating a tension-free, primary sutured repair
No mesh-related complications were ob- of the diaphragmatic hiatus is difficult. It is a dy-
served. namic area due to diaphragmatic excursions with
510 Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair

constant motion, even at rest. Nevertheless, the completely circular mesh. There has been some
goal for repair of the hiatus should be to create a concern about the use of a circular mesh because
tension-free repair. A high recurrence rate after of its potential to cause circumferential fibrosis
laparoscopic primary sutured cruroplasty, espe- around the esophagus, resulting in dysphagia. Our
cially for large hiatal hernias [3, 4], suggests that preference is a V-shaped mesh (CruraSoft) for
suture repair alone does not provide an optimal closing the esophageal hiatus.
tension-free repair. Our own experience demon- The technique for placing prosthetic materials
strated a higher recurrence rate in patients with can be either posterior, anterior onlay, or interpo-
sutured cruroplasty compared with those receiving sitional when reapproximation of the hiatus is pos-
mesh cruroplasty (14.9% vs. 5.8%). sible (⊡ Fig. 66.13). Most surgeons prefer primary
As with hernia repair in other parts of the body, sutured repair of the hiatus followed by an onlay of
there is no consensus on the best prosthetic mate- prosthetic materials posteriorly. The overall theme
rial to use for the procedure. The most commonly remains that hiatal hernia repair should be made
66 used mesh is polypropylene (Prolene; Ethicon) as tension-free as possible, whether via an onlay
[11–13]. Several different types of polytetrafluo- repair or an interpositional repair. Our preference
roethylene (PTFE) and PTFE composite materials is to do an onlay repair for large hiatal hernias
have been used, including DualMesh (Gore, Flag- (>5 cm).
staff, AZ, USA) [14] and a simple PTFE patch [15, The mesh is fixed at the hiatus using sutures,
16]. Porcine small intestinal mucosa (Surgisis; Cook tacks (not our choice), or, recently, fibrin sealant.
Surgical, Bloomington, IN, USA), which provides The topographic vicinity of the heart and other
scaffolding for natural tissue ingrowth, is also used major anatomical structures (liver, inferior vena
[17]. In our initial 27 cases, we used Prolene mesh cava) and the fact that the diaphragm is very thin
because it is readily available, inexpensive, mal- in this area makes suturing technically difficult
leable, and easy to handle. There has been concern and requires surgical expertise. An easier alterna-
about the use of polypropylene mesh because it tive is to apply tacks, but this has resulted in fatal
causes dense fibrosis. As a result, we have started us- complications, including death by cardiac tampon-
ing lightweight, large-pore meshes–Ultrapro (Ethi- ade [18]. The use of a fibrin sealant for mesh fixa-
con) and CruraSoft (Bard)–because they are tissue tion was reported by Katkhouda et al. in an animal
friendly and known to cause less fibrosis. experiment [19]. These authors were able to show
The hiatal meshes are available in variable that fixation with fibrin sealant is mechanically
shapes, including a V-shape, a U-shape, and a equivalent to stapler fixation. In a number of clini-

⊡ Fig. 66.13. Techniques of mesh cruroplasty


Chapter 66 · In Support of Standard Procedure in Hiatal Hernia Repair
511 66
cal studies, both the efficiency of fibrin sealant and tively participating in the »pro standard pro-
also a reduction in postoperative complications cedure in hiatal hernia repair« project and in
have been shown in inguinal hernia repair [20, preparing this article.
21]. The use of fibrin sealant is now also being I am thankful to my colleagues Dr. Rajesh
described for hiatal hernia repair. As protocol, we Khullar, Dr. Anil Sharma, Dr. Vandana Soni, and
prefer sutures for fixing the mesh but have on oc- Dr. Manish Baijal for their invaluable assistance
casion used fibrin sealant and found it to be a safe in completing this project. I am grateful for their
and effective adhesive. constant and positive support in all the ongoing
Higher rates of dysphagia have been reported projects and progress made in the Centre. I express
in patients with mesh cruroplasty [22, 23], and great appreciation to all my fellows and resident
there have been case reports of patients being doctors, Dr. Kshipra Dhawan and Dr. Neeraj Garg,
reoperated for mesh-induced fibrosis [24, 25]. In for their supportive help and efforts.
most studies, the early results have shown a higher I sincerely thank Ms. Aenu Batra, Mr. Pankaj
rate of dysphagia in patients with mesh cruro- Gupta, Ms. Shradha Verma, Mr. Satish Jha, and
plasty, but this rate became comparable at 1 year of Dhuruvendra Singh for their excellent secretarial
follow-up. In our study, the dysphagia rate was also help and support.
comparable at 1-year follow-up (3.8% vs. 4.3%).
Another major concern of using mesh at the
hiatus is erosion of the mesh into the esophagus or References
stomach. Erosion of mesh is very rare and has been
reported only in case reports [26, 27]. In our expe- 1. Arnaud JP, Pessaux P, Ghavami B, Flaments JB, Trebuchet
rience, there were no mesh-related complications. G, Meyer C, Huten N, Champauck G (2000) Laparoscopic
fundoplication for gastroesophageal reflux: multicenter
study of 1470 cases. Surg Endosc 14:1024–1027
Summary 2. Huntington TR (1997) Short-term outcomes of laparosco-
pic paraesophageal hernia repair: a case of 58 consecu-
tive patients. Surg Endosc 11:894–893
Reinforcement of the esophageal hiatus with a 3. Hashemi M, Peters JH, Deemeester TR, Huprich JE, Quek
prosthetic mesh has proven to be a safe and ef- M, Hagen JA, Crookes PF, Theisen I, De Meester SR, Sillin
fective procedure to reduce postoperative hiatal F, Bremner CG (2000) Laparoscopic repair of large type III
hiatal hernia: objective follow up reveals high recurrence
hernia recurrence. A few comparative studies of
rate. J Am Coll Surg 190:553–561
laparoscopic hiatal closure with simple sutures ver- 4. Wiechmann RJ, Ferguson MK, Nauheim KS, McKesey P,
sus mesh cruroplasty have shown that patients Hazelrigg SJ, Santucci TS, Macherey RS, Landreneau RJ
with prosthetic hiatal closure have a lower rate (2001) Laparoscopic management of giant paraesopha-
of hiatal hernia recurrence in comparison to pa- geal hernia. Ann Thoracic Surg 71:1080–1087
5. Schauer PR, Ikramuddin S, McLaughlin RH, Graham TO,
tients with simple hiatal repair. However, some
Slivka A, Lee KK, Schraut WH, Luketich JD (1998) Compari-
patients with prosthetic hiatal closure suffer from son of laparoscopic versus open repair of paraesophageal
prolonged postoperative symptoms such as dys- hernia. Surg 176:659–665
phagia. Fortunately, this resolves in most patients 6. Wichterman K, Geha AS, Cahow CE, Raue AE (1979) Para-
without further treatment. A true complication esophageal hiatus hernia with intrathoracic stomach and
colon: the case for early repair. Surgery 86:497–506
related to the use of prosthetic materials for hiatal
7. Granderath FA, Schweiger UM, Kamoiz T, Ashe KU, Point-
closure is rare. ner R (2006) Laparoscopic Nissen fundoplication with
prosthetic hiatal closure reduces postoperative intratho-
racic wrap herniation. Arch Surg 140:40–48
Acknowledgments 8. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk
EG, Jeekel J (2004) Long-term follow up of a randomized
controlled trial of suture versus mesh repair of incisional
I am thankful to Dr. Tarun Mittal and Dr. Ash- hernia. Ann Surg 240:578–585
ish Dey, my colleagues in the Minimal Access, 9. Lichtenstein IL, Shulman AG, Amid PK, Montlior MM (1989)
Metabolic & Bariatric Surgery Centre, for ac- The tension-free hernioplasty. Am J Surg 157:188–193
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10. Vrijland WW, van den Tol MP, Luijendijk RW, Hop WC, paroscopic paraesophageal hernia repair. J Gastrointest
Busschback JJ, de Lange DC, van Geldere D, Rottier AB, Surg 1:221–228
Vegt PA, IJzermans JN, Jeekel J (2002) Randomized clinical 26. Carlson MA, Condon RE, Ludwig KA (1998) Management
trial of nonmesh versus mesh repair of primary inguinal of intrathoracic stomach with polypropylene mesh pros-
hernia. Br J Surg 89:293–297 thesis reinforced transabdominal hiatus hernia repair. J
11. Basso N, De Leo A, Genco A, Rosato P, Rea S, Spaziani Am Coll Surg 187:227–230
E, Primavera A (2000) 360° laparoscopic fundoplication 27. Schauer PR, Ikramudin S, McLaughlin RH, Graham TO,
with tension-free hiatoplasty in the treatment of symp- Slivka A, Lee KK, Schrayt WH, Luketich JD (1998) Compari-
tomatic gastroesophageal reflux disease. Surg Endosc son of laparoscopic versus open repair of paraesophageal
14:164–169 hernia. Am J Surg 176:659–665
12. Basso N, Rosato P, De Leo A, Genco A, Rea S, Neri Y (1999)
»Tension-free« hiatoplasty, gastrophrenic anchorage and
360° fundoplication in the laparoscopic treatment of pa-
raesophageal hernia. Surg Laparosc Endosc 9:257–262
13. Hawasli A, Zonca S (1998) Laparoscopic repair of paraeso-

66 phageal hiatal hernia. Am Surg 64:703–710


14. Frantzides CT, Madan AK, Carlson MA (2002) A prospec-
tive randomized trial of laparoscopic polytetrafluoroethy-
lene (PTFE) patch repair vs. simple cruroplasty for large
hiatal hernia. Arch Surg 137:649–652
15. Athanasakis H, Tzortzinis A, Tsiaoussis J (2001) Laparoscopic
repair of paraesophageal hernia. Endoscopy 33:590–594
16. Carlson MA, Richards CG, Frantzides CT (1999) Laparosco-
pic reinforcement of hiatal herniorrhaphy. Diag Surg 16:
407–410
17. Oelschlager BK, Barreea M, Chang L, Pellegrini CA (2003)
The use of small intestine submucosa in the repair of
paraesophageal hernias: initial observations of a new
technique. Am J Surg 186:4–8
18. Kemppainen E, Kiviluoto T (2000) Fatal cardiac tampo-
nade after emergency tension-free repair of a large para-
esophageal hernia. Surg Endosc 14:593
19. Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu
M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani
R (2001) Use of fibrin sealant for prosthetic mesh fixation
in laparoscopic extraperitoneal inguinal hernia repair.
Ann Surg 233:18–25
20. Lau H (2005) Fibrin sealant versus mechanical stapling for
mesh fixation during endoscopic extraperitoneal inguinal
hernioplasty. Ann Surg 242:670–675
21. Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S,
Dalenback J (2006) Fibrin glue for securing the mesh in la-
paroscopic totally extraperitoneal inguinal hernia repair.
Surg Endosc 20:462–467
22. Granderath FA, Schweiger UM, Kamolz T, et al. (2002)
Laparoscopic antireflux surgery with routine mesh-hi-
atoplasty in the treatment of gastroesophageal reflux
disease. J Gastrointestinal 6:347–353
23. Kamolz T, Granderath FA, Bammer T, Pasiut M, Pointner
R (2002) Dysphagia and quality of life after laparosco-
pic Nissen fundoplication in patients with and without
prosthetic reinforcement of the hiatal crura. Surg Endosc
16:572–577
24. Edelman DS (1995) Laparoscopic paraesophageal hernia
repair with mesh. Surg Laparosc Endosc 5:32–37
25. Trus TL, Bax T, Richardson WS, Branum GD, Mauren SJ,
Swanstrom LL, Hunter JG (1997) Complications of la-
67

Strategy To Improve the Results?


In Support of Individualized
Procedures in Hiatal Hernia Repair
J. F. Kukleta
514 Chapter 67 · Strategy To Improve the Results? In Support of Individualized Procedures in Hiatal Hernia Repair

Introduction troversies, identify potential improvements of the


surgical technique, and reinforce the position of an
It has recently become evident that the durability of advocate of patient-related, individualized proce-
crural repair determines not only the outcome qual- dures for hiatal hernia repair in order to improve
ity of paraesophageal hernia (PEH) repairs but the outcomes.
long-term success of antireflux procedures as well.
Because of the personal experience of individual
surgeons and surgical teams with the complexity of Material
hiatal repairs, several different techniques have been
proposed to correct this diaphragmatic disorder. For many years it was thought that reflux and all
The results of the surgical treatment are far from be- its sequelae could be controlled by a tight wrap
ing excellent solutions for all patients for all esopha- to increase the lower esophageal sphincter pres-
geal and extraesophageal symptoms, but in general, sure and prevent the reflux [7]. A high incidence
they promise good or satisfactory outcomes ap- of moderate to severe dysphagia and inability to
proximately 85–90% of the time. Since the introduc- belch was the consequence. The formation of a
67 tion of laparoscopic techniques in hiatal repair, the shorter and floppy fundoplication evolved as a
problematic cure has become even more complex, logical answer to a recognized inadvertent com-
partly due to the learning curve for everyone. plication. Today the successful control of reflux
Several reviews of the available published data is related to restoring adequate length of the ab-
on the hiatal environment [1–3] are quite repre- dominal esophagus, bringing the gastroesophageal
sentative of the status quo: The procedures are not junction back into the positive intraabdominal
standardized, and data with high levels of evidence pressure environment, creating a floppy full wrap
are lacking. There are too many controversies and or partial wrap, and preventing intrathoracic wrap
very little consensus. migration by achieving a durable crural repair. The
The recurrence rate of a laparoscopic simple- partial wrap (Toupet [8]) was believed to be less
sutured PEH repair ranges from 0% to over 40% efficient in preventing the reflux but more reliable
[4]. The most important mechanism of failure of in preventing dysphagia. Therefore, this technique
antireflux procedures is, in 60–84% of cases, migra- was recommended to be used in patients with ad-
tion of the intrathoracic wrap [5, 6]. Both failures ditional motility disorders of the distal esophagus.
are sequelae of insufficient closure or disruption of Some of the above-mentioned beliefs could not be
the crural repair. Unlike in endoscopic repairs for confirmed in prospective controlled trials, which
inguinofemoral or abdominal wall hernias, in which brought up additional doubts about the correct-
the use of prosthetic meshes is a well-accepted part ness of our pathophysiological understanding [9].
of a successful tension-free repair concept, the use The successful application of prosthetic meshes
of meshes in hiatal repairs is still under debate [3]. in the cure of groin and abdominal wall hernias
To improve the results of hiatal disorders, the influenced the treatment of large hiatal hernias
causes of failure must be analyzed, the predictors of types II–IV [10]. Various mesh materials were
taken into account, and the »pillars of the best used to either reinforce the sutured crural repair or
outcome« identified and reinforced. If the risk of to cover the large nonsutured defect in a tension-
repair failure is anticipated, then individual adapta- free manner. The few sporadic reports on late
tion of the surgical technique can help prevent this mesh-related complications [11–14], regardless of
situation. the material used, raised an ongoing discussion on
risks and benefits, in which gut feelings and low
scientific evidence were used to try to convince
Concept one another. The incidence of mesh-related com-
plications is obviously underreported. The major-
The objective of the following analysis of avail- ity of existing studies are retrospective, and data of
able published experiences is to highlight the con- higher levels of evidence are scarce.
Chapter 67 · Strategy To Improve the Results? In Support of Individualized Procedures
515 67
Analysis of the causes of recurrence contributes Basso et al. improved their recurrence rate of
to better understanding of the pathogenesis and 9% of sutured crurorrhaphy to 0% when they rein-
enables possible correction of the operative tech- forced their sutured crural repairs with a posterior
nique [15]. Among the factors predicting repair buttressing polypropylene mesh [19].
failure, lack of surgical expertise is one of the most Granderath et al. [20] reviewed 42 studies re-
important. Once again, it seems to be difficult to garding prosthetic hiatal closure. Mesh repairs
differentiate whether the surgeon’s experience and markedly reduced the recurrence rates both in
expertise or a successful therapeutic concept has a paraesophageal and antireflux surgery, with low
more significant impact on outcome. complication rates. The mesh material and its size
and shape are still controversial [20].

Arguments
Risk of Mesh-Related Complications
Main Problem–Crural Repair Failure
Very few reports have been published on pros-
Champion and McKernan [16] prospectively thetic complications such as erosion, stenosis, pen-
measured hiatal diameters in 476 primary laparo- etrations, and migrations [11–14]. Although these
scopic antireflux procedures. The smaller defects incidents are surely underreported, their numbers
(<4.5 cm) led to a recurrence rate of 0.9%. The are too small to justify a general reluctance to use
bigger ones (>5 cm) showed recurrence in 10.6% mesh in high-risk repairs. Even though the major-
of cases. The difference is highly significant: p< ity of published results report no erosions, longer
0.000001. The size of the hiatus matters. follow-up is necessary because some complications
In 2001 Carlson and Frantzides [6] published of a similar type (pledget erosion) may not appear
a review of 10,735 reported cases of minimally until after more than 6 years [21, 22]. To avoid
invasive antireflux procedures. The most common the lifelong risk of potential complications from
finding at redo operation for the failed repair was permanent prosthetic material, a new category of
an intrathoracic wrap herniation due to ruptured reinforcing biomaterials has been proposed [23].
crural closure [5, 6]. However, the role of the various acellular scaffolds
of human or porcine/ bovine origin is unclear and
their value still unpredictable.
Mesh Reinforcement Reduces the
Recurrence Rate in Hiatal Repair
Does the 360° Wrap Control Reflux
The literature review by Johnson et al. [2] on the Better Than the Partial Wrap?
use of mesh in hiatal repair demonstrates a highly
significant reduction in recurrence rate in anti- Strate et al. [9] randomized 100 Nissen and 100
reflux and PEH procedures when mesh was used Toupet procedures with and without preoperative
either to reinforce the sutured repair or as a true esophageal motility disorders. After 2 years, the
tension-free repair. patients with Nissen fundoplication had a higher
Champion and Rock [17] reduced their recur- incidence of dysphagia, but the Toupet repair con-
rence rate in laparoscopic sutured crural repair from trolled the reflux equally or insignificantly better
10.6% to 1.9% by employing a polypropylene mesh than the Nissen repair. The patients’ preexisting
to reinforce the sutured repair in 52 patients. motility impairments did not correlate with the
Frantzides et al. [18] presented a randomized postoperative complaints, so the authors declared
controlled study comparing laparoscopic sutured that tailoring antireflux procedures according to
cruroplasty and expanded-polytetrafluoroethyl- esophageal motility is not indicated.
ene-reinforced sutured cruroplasty. The recurrence Wykypiel et al. [24] confirmed the equal ef-
rate of 22% improved to 0% in mesh repair. ficiency of reflux control of Toupet compared with
516 Chapter 67 · Strategy To Improve the Results? In Support of Individualized Procedures in Hiatal Hernia Repair

Nissen, besides restoring the preoperatively im- onstrates the necessity to technically improve
paired bolus propagation after the Toupet proce- the durability of the cruroplasty.
dure. Both groups of researchers [9, 24] found the 4. Among the factors related to hiatal hernia
Toupet procedure to be the better one, with fewer recurrence are technical reasons, anatomic
side effects. reasons (different hernia types I–IV, size of the
hiatus, condition of the crura), and patient-
related reasons, including obesity, chronic
Why We Should Adapt the Surgical obstructive pulmonary disease, constipation,
Technique to the Individual Patient weight lifting, age, vomiting in the early post-
operative course, early physical activity, and
1. Most patients with large paraesophageal so on. Patients with these predisposing factors
hernias are elderly. For many years, patients should probably be primarily offered a mesh-
may stay asymptomatic. Historically, treat- reinforced crural repair.
ment was open surgical management of a 5. Mesh decreases the risk of recurrence in hiatal
large diaphragmatic defect too invasive for an repair [2, 17–19, 30, 31], but it carries the risk
67 older, minimally symptomatic patient who of mesh-related complications. These are very
frequently already had other comorbidities. rare but may have disastrous consequences.
Because of rare but well-known and possibly To eliminate this small but serious risk, sev-
life-threatening complications [25], we contin- eral surgeons promote the use of biomeshes,
ued to offer these patients a »prophylactic op- namely porcine small intestine submucosa
eration« with a mortality of 0–5.4%. Accord- [23].
ing to Stylopoulos et al. [26], the probability Johnson et al. [2] reviewed the available lit-
of needing emergency surgery is only 1.16% erature and identified 19 studies reporting on
in the asymptomatic group. Therefore, only the use of mesh in hiatal repair (PEH, lap-
symptomatic or progressively symptomatic aroscopic fundoplication for reflux, or both).
older patients should undergo elective surgery. There were 729 sutured repairs and 639 mesh
2. The incidence of failure of laparoscopic sim- repairs with or without crura closure. After 20
ple-sutured hiatal repair in patients with PEH months, there were fewer recurrences in the
is known to be quite high. Especially in series mesh group: 1.8% vs. 10.7%. No erosion was
with systematic follow-up and consequent bar- reported in this study or in series published by
ium swallow examination, the recurrence rate Frantzides et al. [18], Basso et al. [19], Gryska
ranges from 0% to 42% [4]. Nevertheless, the and Vernon [30], Granderath et al. [31], and
majority of patients are symptomatically im- Champion and Rock [17].
proved and do not require interventions, just The awareness of potential mesh-related late
observation [27]. White et al. [27] conducted a sequelae in the dynamic hiatal area is certainly
10-year follow-up of 31 patients who had had important. Nevertheless, by respecting the
laparoscopic repair of PEH. They found that individual patient’s failure-risk profile, there
heartburn had improved from 54% to 12%, must be a place for primary mesh-reinforced
chest pain from 36% to 9%, dysphagia from crural repair rather than waiting for a failure
30% to 3%, and regurgitation from 50% to and then using the mesh in a technically de-
6%, despite the recurrence rate of 32%. Only a manding redo repair later on. The lightweight,
small group needed reoperation. megaporous, and oligofilament meshes have
3. The failure rate after fundoplication for reflux demonstrated less chronic inflammatory reac-
disease after 5-year follow-up is 10–15% [28]. tion and limited shrinkage in inguinal hernia
The most common failure pattern is intratho- repair. With this prosthetic material there is a
racic herniation of the intact wrap (61–84%) justified expectation of good performance and
due to disruption of the crural repair [5, 6, low risk in hiatal repair as well, but long-term
29]. The reoperation rate of around 10% dem- results are still lacking.
Chapter 67 · Strategy To Improve the Results? In Support of Individualized Procedures
517 67

⊡ Fig. 67.1. Small hiatal surface area ⊡ Fig. 67.3. Large hiatal surface area

⊡ Fig. 67.2. Low tension on the suture line ⊡ Fig. 67.4. Higher risk of crural repair failure

6. The risk of failure of the crural repair is pre- ▬ The recurrence risk depends strongly on the
dominantly determined by the size of the size of the hiatus and the condition of the
hiatus and the condition of the crura [32]. crura. This justifies the simple sutured repair
Measuring the hiatal surface area gives a ratio- in patients with small hiatal defects and mesh-
nal background for a tailored concept of hiatal reinforced suture repair in patients with bigger
closure (⊡ Figs. 67.1–67.4). defects, weak crura, and/or additional elevated
risk factors.
▬ The traditional validation of Nissen vs. Toupet
Conclusions wrap must be scrutinized or reconfirmed [9,
24, 33–35].
▬ Solidity and durability of crural repair are key, ▬ The individualized approach to hiatal hernia
both for antireflux procedures as well as for repair (tailored repair [32]) must reflect the
PEH repair. risk–benefit ratio of each individual patient,
▬ Patients with increased recurrence risk should based on the available evidence from long-
probably be offered a primary mesh-rein- term follow-up if possible.
forced repair.
518 Chapter 67 · Strategy To Improve the Results? In Support of Individualized Procedures in Hiatal Hernia Repair

References 17. Champion JK, Rock D (2003) Laparoscopic mesh cruro-


plasty for large paraesophageal hernias. Surg Endosc 17:
1. Draaisma WA, Gooszen HG, Tournoij E, Broeders IAMJ 551–553
(2005) Controversies in paraesophageal hernia repair. 18. Frantzides C, Madan A, Carlson M, Stavropoulos G (2002)
Surg Endosc 19:1300–1308 A prospective, randomized trial of laparoscopic polytetra-
2. Johnson JM, Carbonell AM, Carmody BJ, Jamal MK, Maher fluoroethylene (PTFE) patch repair vs simple cruroplasty
JW, Kellum JM, De Maria EJ (2006) Laparoscopic mesh hia- for large hiatal hernia. Arch Surg 137:649–652
toplasty for paraesophageal hernias and fundoplications. 19. Basso N, DeLeo A, Genco A, Rosato P, Rea S, Spaziani E,
Surg Endosc 20:362–366 Privaera A (2000) 360° laparoscopic fundoplication with
3. Targarona EM, Bendahan G, Balague C, Garriga J, Trias M tension-free hiatoplasty in the treatment of symptomatic
(2004) Mesh in the hiatus–a controversial issue. Arch Surg gastroesophageal reflux disease. Surg Endosc 14:164–
139:1286–1296 169
4. Hashemi M, Peters JH, DeMeester TR, Huprich JE, Quek M, 20. Granderath FA, Carlson MA, Champion JK, Szold A, Basso
Hagen JA, Crookes PF, Theisen J, DeMeester SR, Sillin LF, N, Pointner R, Frantzides CT (2006) Prosthetic closure of
Bremmer CG (2000) Laparoscopic repair of large type III the esophageal hiatus in large hiatal hernia repair and
hiatal hernia: objective follow-up reveals high recurrence laparoscopic antireflux surgery. Surg Endosc 20:367–
rate. J Am Coll Surg 190:553–560 379
5. Hunter JG, Smith CD, Branum GD (1999) Laparoscopic 21. Dally E, Falk GL (2004) Teflon pledget reinforced fundopli-
67 fundoplication failures: patterns of failure and response
to fundoplication revision. Ann Surg 230:595–604
cation causes symptomatic gastric and esophageal lumi-
nal penetration Am J Surg 187:226–229
6. Carlson MA, Frantzides CT (2001) Complications and results 22. Balladas HG, Smith GS, Richardson MA, Dempsey ME,
of primary minimally invasive antireflux procedures: a re- Falk GL (2000) Esophagogastric fistula secondary to Tef-
view of 10,735 reported cases. J Am Coll Surg 193:428–439 lon pledget: a rare complication following laparoscopic
7. Nissen R (1956) A simple operation for control of reflux fundoplication. Dis Esophagus 13:72–74
esophagitis. Schweiz Med Wochenschr 86:590–592 23. Oelschlager BK, Barreca M, Chang L, Pellegrini CA (2003)
8. Toupet A (1963) Technique of esophago-gastroplasty The use of small intestine submucosa in repair of paraeso-
with phrenogastropexy used in radical treatment of hiatal phageal hernias: initial observations of a new technique.
hernias as a supplement to Heller’s operation in cardio- Am J Surg 186:4–8
spasms. Mem Acad Chir (Paris) 89:384–389 24. Wykypiel H, Hugl B, Gadenstaetter M, Bonatti H, Bodner J,
9. Strate U, Emmermann A, Fibbe C, Layer P, Zornig C (2008) Wetscher WJ (2008) Laparoscopic partial posterior (Tou-
Laparoscopic fundoplication: Nissen versus Toupet two- pet) fundoplication improves esophageal bolus propaga-
year outcome of a prospective randomized study of 200 tion on scintigraphy. Surg Endosc 22:1845–1851
patients regarding preoperative esophageal motility. 25. Skinner DB, Belsey RH (1967) Surgical management of
Surg Endosc 22:21–30 esophageal reflux and hiatus hernia. Long-term results
10. Kuster GG, Gilroy S (1993) Laparoscopic technique for with 1030 patients. J Thorac Cardiovasc Surg 53:33–54
repair of paraesophageal hiatal hernias. J Laparoendosc 26. Stylopoulos N, Gazelle GS, Rattner DW (2002) Paraeso-
Surg 3:331–338 phageal hernias: operation or observation? Ann Surg
11. Carlson MA, Condon RE, Ludwig KA, Schulte WJ (1998) 236:492–500
Management of intrathoracic stomach with polypropy- 27. White BC, Jeansonne LO, Morgenthal CB, et al. (2008)
lene mesh prosthesis reinforcement transabdominal hia- Do recurrences after paraesophageal repair matter? Surg
tus hernia repair. J Am Coll Surg 187:227–230 Endosc 22:1107–1111
12. Trus TL, Bax T, Richardson WS, Branum GD, Mauren SJ, 28. Franzén T, Anderberg B, Wirén M, Johansson KE (2005)
Swanson LL, Hunter JG (1997) Complications of lapa- Long-term outcome is worse after laparoscopic than after
roscopic paraesophageal hernia repair. J Gastrointest conventional Nissen fundoplication. Scand J Gastroente-
Surg 1:221–228 rol 40:1261–1268
13. Coluccio G, Ponzio S, Ambu V, Tramontano R, Cuomo G 29. Cadiere GB, Bruyns J, Himpens J, Vertruyen M (1996) Intra-
(2000) Dislocation into cardiac lumen of a PTFE prosthetic thoracic migration of the wrap after laparoscopic Nissen
used in the treatment of voluminous hiatal sliding hernia, fundoplication. Surg Endosc 10:187 (S43)
a case report. Minerva Chir 55:341–345 30. Gryska PV, Vernon JK (2005) Tension-free repair of hiatal
14. Zilberstein B, Ashkenasy R, Pajecki D, Granja C, Brito ACG hernia during laparoscopic fundoplication: a ten-year ex-
(2005) Laparoscopic mesh repair antireflux surgery for treat- perience. Hernia 9:150–155
ment of large hiatal hernia. Dis Esophagus 18:166–169 31. Granderath F, Kamolz T, Schweiger M, Pasiut M, Haas C,
15. Filipi CJ (2000) Laparoscopic hiatal hernia repair: why they Wykypiel H, Pointer R (2002) Long-term results of lapa-
fail. Hernia 4:219–222 roscopic antireflux surgery. Surg Endosc 16:753–757
16. Champion JK, McKernan JB (1998) Hiatal size and risk of 32. Granderath FA, Schweiger UM, Pointner R (2007) Lapa-
recurrence after laparoscopic fundoplication [abstract]. roscopic antireflux surgery: tailoring the hiatal closure to
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519 67
33. Spechler SJ, Lee E, Ahnen D, Goyal R, Hirano I, Ramirez F,
Raufman JP, Sampliner R, Schnell T, Sontag S, Vlahcevic Z,
Young R, Williford W (2001) Long term outcome of me-
dical and surgical therapies for gastroesophageal reflux
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34. Kamolz T, Granderath FA, Bammer T, Pasiut M, Pointner
R (2002) Dysphagia and quality of life after laparosco-
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35. Hunter JG, Swanstrom L, Waring JP (1996) Dysphagia after
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technique. Ann Surg 224:51–57
68

Questionnaire
522 Chapter 68 · Questionnaire

1. How many hernias do you perform 4. Spermatic Cord


each year?
A. Do you believe that infertility (due to obstruc-
▬ Inguinal 6,175 tive azoospermia or ischaemic orchitis) is a
▬ Incisional 1,935 potential complication of inguinal hernia re-
▬ Hiatal 486 pair?
▬ Yes 85%
▬ No 15%
2. Percentage of Operations
Performed (%) B. Do you believe that the type of repair
(mesh vs. nonmesh) has an impact on the
▬ Inguinal integrity of the vas deferens and testicular
– Lichtenstein 35% function?
– Shouldice 13% ▬ Yes 62%
– TAPP 14% ▬ No 38%
– TEP 25%
– TIPP-Rives <1% C. Do you believe that the type of the mesh used
– Stoppa <1% (small porous mesh vs. large porous mesh) has
68 – Wantz <1% an impact on the integrity of the vas deferens
– Plug/PHS 8% and testicular function?
– Others 3% ▬ Yes 56%
▬ Hiatal ▬ No 44%
– With mesh 20%
– Without mesh 80% D. Is potential alteration of the spermatic cord
▬ Incisional a reason to tailor your approach in inguinal
– Sublay 51% hernia repair (i.e. young men, single tes-
– Onlay 3% ticle)?
– Inlay 4% ▬ Yes 74%
– IPOM 40% ▬ No 26%
– Others 2%

5. Infection
3. Type of Mesh Actually Used
A. Do you use single-shot antibiotic prophylaxis
Ingui- Inci- Hiatal in hernia surgery to prevent infections?
nal sional

Polypropylene 35% 21% 0 Inguinal hernia Incisional hernia Hiatal hernia


(i.e. Atrium, Marlex)
Yes 70% Yes 92% Yes 60%
Large porous polypro- 48% 33% 37%
No 30% No 8% No 40%
pylene (i.e. UltraPro)

Polyester (i.e. Mersilene) 10% 7% 0


B. Do you believe that the kind of mesh materi-
ePTFE (i.e. DualMesh) 5% 24% 8%
als (structure, polymer, kind of filament, pore
Biological mesh (i.e. 0 10% 42% size) has an impact on infection rate?
Surgisis)
▬ Yes 69%
Others 2% 5% 13% ▬ No 31%
Chapter 68 · Questionnaire
523 68
C. Do you implant permanent mesh materials C. Should a suspected injured nerve be saved or
(no biological meshes) in potentially contami- resected?
nated fields? ▬ Saved 4%
▬ Resected 96%
Hernia repair for incarcerated inguinal/
incisional hernias
D. How do you resect a nerve?
▬ Yes 90%
▬ No 10%
How? Ligate the Place end in
Hernia repair + elective cholecystectomy end? muscle?
▬ Yes 77%
Scissor 79% Yes 33% Yes 52%
▬ No 23%
Knife 7% No 67% No 48%
Hernia repair + iatrogenic small bowel
enterostomy Cautery 14%
▬ Yes 56%
▬ No 44%
E. Do you try to identify all three nerves during
Hernia repair + iatrogenic large bowel open inguinal hernia repair?
enterostomy ▬ Yes 40%
▬ Yes 21% ▬ No 60%
▬ No 79%

D. Do you think there is a place for an antibiotic- 7. Adhesion/Migration/Erosion


supplemented mesh in hernia repair to pre-
vent/treat infections? A. Do you believe in adhesions as a chronic in-
flammatory process?
In clean cases In contaminated In infected cases ▬ Yes 85%
cases ▬ No 15%
Yes 26% Yes 70% Yes 50%
B. Which factors are responsible for the develop-
No 74% No 30% No 50% ment of adhesions?
▬ Surgical technique (peritoneal
damage) 100%
▬ Kind of mesh material 96%
6. Chronic Pain ▬ Kind of fixation 93%
▬ Patient’s individual response 86%
A. Do you believe that patient-related factors (i.e.
age, gender, body mass index) are of major C. Which factors determine the adhesive potency
importance for the development of postopera- of a mesh material (multiple answers pos-
tive neuropathic pain? sible)?
▬ Yes 74% ▬ Polymer 79%
▬ No 26% ▬ Pore size 93%
▬ Kind of filaments (mono vs. multi) 79%
B. Do you believe that optimised (i.e. larger ▬ Kind of antiadhesive barrier 89%
pores, monofilaments) mesh materials are able
to decrease the overall amount of postopera- D. Have you ever seen complications following
tive neuropathic pain? hiatal hernia repair using a mesh material?
▬ Yes 78% ▬ Yes 52%
▬ No 22% ▬ No 48%
524 Chapter 68 · Questionnaire

E. Is there a need for further mesh optimisation


for placement in the hiatal region?
▬ Yes 95%
▬ No 5%

68
Subject Index

Cellular infiltration 108


A B Central nervous plasticity 181
Central neuroinflammation 171
Abdominal colposuspension 440 Bacterial colonization 395 C-fibers 210
Abdominal stiffness 223 Bacterial contamination 120 Chemical barriers 357
Abdominal wall compliance 347 Bacterial resistance 126, 132 Chronic groin sepsis 114, 116
Abdominal wall surface 144 Band disconnection 430 Chronic inguinal pain 293
Abdominopelvic pain 306 Band erosion 430, 432 Chronic inguinodynia 290
Acute inflammatory response 366 Band migration 432, 434, 435 Chronic pain 221, 222, 246, 257,
Acute laparotomy wound failure Bariatric surgery 435 258, 266, 280, 294
402 Bassini 464, 468 Classification 120, 229, 494
Adhesion 345, 354, 346, 378, 385, Bcl-2 (oncoprotein) 45 C-myc 306, 309, 311
446 Bioacoustic effect 122 Collagen 172
Afferent nociceptors 172 Biocompatibility 377 Collagen coating 282, 389
Allodynia 170, 180 Biofilm 121 Collagen deposition 368
Amnion-derived cells 402 Biological tissue grafts 318 Color doppler ultrasound (CDUS) 5
Amniotic cell therapy 405 B-lymphocytes 306 Complex regional pain syndromes
Antiadhesive barrier 348 Bridging 223, 228 (CRPS) 170, 208
Antibiotic prophylaxis 126 Bulging 147 Component separation technique
Antireflux procedure 504 143
Anxiety 164 Composite biomaterials 356, 394
Arcuate line 488 Condensed PTFE (cPTFE) 355
Aß-fiber 210
C Contaminated environment 144
Augmentation 228 Contaminated surgical field 104
Autologous skin 498 Catecholamine-O-methyltrans- Contamination 116
Axon 178 ferase (COMT) 194 Cooper’s ligament 488
Axonotmesis 178 ß-catenin 306, 309, 311 COX-2 309
Aδ-fiber 210 Cefazolin 138 Crural repair 517
526 Subject Index

Cyclooxygenase-2 306, 311 Fibrin glue 357 Hyaluronic acid/carboxymethylcel-


Cytokine growth factors 402 Fibroblastic response 270 lulose (HA/CMC) membranes
Fibroblasts 172, 311, 367 357
Fibrocollagenous ingrowth Hyaluronidase cream 357
378 Hyperalgesia 170
D Fistula formation 120, 121, 458 Hyperexcitability 170
Fixation 165, 258 Hyperpathic pain 180
Deep infections 116 Flap 499
Degeneration 170 Follicle-stimulating hormone (FSH)
Depression 164, 195 58
Discomfort 223, 246 Foreign body reaction 215, 423
I
Double-crown technique 453 Foreign body response 259
Drains 132 Foreign body sensation 276 Ideal mesh 373
DualMesh 382, 397 Francis Usher 369 Iliohypogastric nerve 178, 240, 289
DynaMesh IPOM 382 Fundoplication 506 Ilioinguinal nerve 178, 240
Dysejaculation 192 Impaired quality of collagen matrix
Dysesthesia 210 synthesis 402
Dyspareunia 442 Improved laparotomy wound
Dysphagia 511
G repair 405
Incisional hernia 221, 325, 332,
Gastric banding 430 402, 486
Gastric fundus 507 – Formation 407
E Gastric herniation 414 – Model 403
Gastroesophageal junction 506 – Repair 376
Early infections 80 Gastroesophageal reflux disease Individualized therapy 170
Early wound failure 407 (GERD) 504 Indocyanine green (ICG) 31
Effective porosity 378 Gastroplasty 508 Infection 87, 126
Elasticity 236 Genetic factors 166 – of a prosthetic material 395
Encapsulation 346 Genetic polymorphisms 194 – Rate 447
Enterotomy 335, 338 Genetic variation 161 Infertility 306
Entrapment 178, 180, 266, 294 Genitofemoral nerves 178, 240 Inflammation 121
Epineural fibrosis 179 Genotype 194 Inflammatory
Epineurectomy 179 Gentamicin 136 – Cells 186, 367
Epineurium 178 Global infection score (GIS) 482 – Pain 170
Epineurotomy 179 Guidelines 478 – Reaction 116, 441
ePTFE 44, 324, 356, 376, 382, 394 Guillain-Barré syndrome 193 – Response 223, 394, 446
398 Ingrowth maturation process
Erosion 434, 440, 442, 458 368
European guidelines 201, 476 Inguinal Pain Questionnaire (IPQ)
Evidence-based medicine 480
H 194
Extensive scar tissue 223 Inguinodynia 287
Haematogenous spread 116 Interfascicular neurolysis 179
Hernia recurrence 109, 336, 394 International Association for the
Hiatal hernia repair 416 Study of Pain (IASP) 209
F Hiatoplasty 425 Intragastric band migration 430
Human acellular dermis (HADM) Intraneural blood flow 188
Fascicles 178 104 Intraperitoneal onlay mesh (IPOM)
Fatty triangle 490 Hyaluronic acid 388 82, 376, 446, 494
527
Subject Index

IPOM 324 Mayo technique 497 Neurotomy 181


– Rabbit model 377 Mesh attachment 223 Nissen Fundoplication 422, 515
Mesh bowel intrusion 120 Nitric oxide (NO) 58
Mesh bridging 495 Nociceptive stimulus 164, 170
Mesh contraction 345, 346, 348 Nociceptive system 164
J Mesh cruroplasty 504, 510 Nonsteroidal anti-inflammatory
Mesh explantation 293 drugs 165
Johnsen Score 23 Mesh infection 79, 119, 120, 336, Notch-3 306, 309
338, 447
Mesh inguinodynia 266
Mesh migration 423, 425, 458
K Mesh-related infections 98
O
Mesh removal 115, 166, 296
Keyhole technique 455 Mesh shrinkage 424 Obstructive azoospermia 51
Ki67 23, 368, 383 Mesh surface 378, 386 Onlay techniques 82, 222
Kugel repair 465 Mesh surgery in urogynecology Open onlay mesh 494
440 Orchialgia 240, 287
Microneurolysis 179 Orchitis 253
Midline tension 223 Overlap 356
L Monocytes 383
Monofilament polypropylene (PP)
Laparoscopic fundoplication 414 98
Laparoscopic hiatal hernia repair Mononuclear round cells 311
P
504 MycroMesh (MM) 395, 397
Laparoscopic ventral hernia repair Myelin degeneration 258 Pain 166, 233, 252, 276
82, 332, 366 Pain level 236
Laparotomy wound breaking Pain transmission 156
strength 403 Pampiniform plexus 73
LAPSIS trial 497
N Paraesophageal hernia 414, 422,
Large-pore mesh 186, 376 504, 514
Late infections 80 National database 476 Paraesthesia 223
Learning curve 465 Nerve damage 148 Parastomal hernia 325, 446, 447,
Lichtenstein 5, 14, 23, 52, 126, 252, Nerve division 243 452
464, 469 Nerve identification 239 Parietene composite 382
Lightweight mesh 276, 376 Nerve injury 165 Parietex composite 382
Lightweight polypropylene/ Nerve roots 178 Pathological regeneration 170
carboxymethylcellulose 371 Nerve trauma 156 Patient safety in surgery 481
Linea alba 402 Neuralgia 253 PCNA reaction 46
Local anaesthesia 165 Neurapraxia 178 PDS (polydioxanone) 388
Luteinizing hormone (LH) 58 Neurectomy 166, 170, 241, 293, Peak systolic velocity (PSV) 5
294, 296 Pelvic organ prolapse 440
Neurofibromatosis 193 Perfusion-related fluorescence
Neuroma 178 intensity (IC-CALC) 31
M Neuroma pain 180 Perineurium 179
Neuromodulation 178, 182 Peripheral surgical trauma 156
Macrophages 306, 309, 311, 383, Neuropathic-Pain 166, 170, 269, Peritoneal adhesions 306
396 288, 294, 466 Phenotype 194
Marlex 22, 30, 377 Neurotmesis 178 Physical barriers 357
528 Subject Index

Physical fitness 195 Sliding hernia 504


Physical impairment 195 Q Sling procedure 440
Physiotherapy 195 Slippage 430, 507
Planimetric analysis 386 Quality of life 258 Slipped nissen phenomenon
Plug repair 301 Questionnaire 229 414
Polyester 44 Small bowel obstruction 306
Polyglactin 910 mesh (PGM) 356 Small-pore meshes 186
Polyneuropathy 170 Soft Tissue Patch (STP) 394, 397,
Polypropylene 44, 126, 280, 355,
R 398
367, 377, 446 Sonographic resistive index (RI) 4
Polypropylene/expanded polytet- Randomized controlled trial (RCT) Spermatic cord 30, 270
rafluoroethylene (ePTFE) 367 468 Spermatogenesis 31
Polypropylene mesh (PPM) , 355 Reactivation 195 Spinal ganglion 181
Polytetrafluoroethylene 446 Real-time adhesion formation 354 Spiral tacks 234, 354
Polyvinylidene fluoride (PVDF) 22, Recurrence rate 442, 452, 486 Standardisation 476
376, 382, 446 Recurrence rates after parastomal Standard procedure 472
Pore size 223, 369, 376 hernia mesh repair 452 Staphylococcus aureus 115, 136
Porosity 369 Reflex sympathetic dystrophy 208 Stem-cell-like multipotent cells
Postherniorrhaphy groin pain 164, Rehabilitation 195 express 402
204, 279 Reherniation 149 Stem cells 401, 402
Postherniorrhaphy inguinodynia Retroesophageal window 506 3D stereography 347
240 Retromuscular space 490 s-testosterone 15
Postimplantation biomechanical Retroperitoneal triple neurectomy Stoppa 464
strength 398 300 Stress urinary incontinence 440
Postoperative pain 234, 336 Revascularization 108 sublay technique 222
Postoperative sensory dysfunc- Risk factor 164, 494 Suburethral sling 440
tions 165 Rives 486 Sudeck’s atrophy 208
Pouch dilatation 430 Superficial infections 114
Predictors of complications 252 Surgical site infection (SSI) 98,
Preoperative investigation 504 114, 106
Preoperative pneumoperitoneum
S Surgical strategy 499
486, 498 Surgical trauma 161
Prevention 136 Sandwich technique 455 Suture cruroplasty 504
Proceed 382 Scar plate 350 Suture pull-out force 284
Prognostic factors 229 – Formation 224 Suture repair 228
Prolene 14, 44 Scar retraction 417 Sweat secretion test 218
Proliferating cell nuclear antigen Scar tissue 270 Swedish Hernia Register (SHR) 201
45 Schwann cells 172
Prophylactic antibiotics 84, 116 Self-assessment (SA) levels 156
Prophylactic neurectomy 242 Seroma 336
Prostheses 161 – Formation 98
T
Prosthetic infection 497 Sexual dysfunction 192
Prosthetic mesh 486, 511 SF-36 questionnaire 280 Tailored approach 299, 472, 483,
Prosthetic mesh infection 109 Shouldice 30, 464, 469 494
Prosthetic reinforcement 417 Shrinkage 383, 387, 441, 458 Tailored concept 81
Pseudoneuroma 178 Single-peptide wound therapy TAPP 203, 480
Psychosocial factors 194 407 Targeted 170
PVDF 324 Skin necrosis 146, 147 Technical failure 471
529
Subject Index

Tensile strength 397


Tensiometric measurements 404
TEP 5, 201, 203, 480
Testicular atrophy 4, 5
Testicular torsion 7
TGF-β 405
Thermography 24
TiMesh Light 382
Tissue incorporation 398
Tissue ingrowth 345, 346, 365, 376
Tissue–prosthesis overlap 339
Tissue response 394
Titanium-coated meshes 383
T-lymphocytes 306, 309, 311, 383
Toupet 514, 515
Toxicity 138
Trabucco 52
Triple neurectomy 181, 288
TUNEL 59
– Histochemistry 23

V
Vacuum-assisted closure (VAC)
therapy 122, 326
VAS 280
Vasography 14, 23
Von Willebrand factor 45, 46
Vypro II 14, 44

W
Wallerian degeneration 179, 215
Wantz 464
Watchful waiting 480
Wound breaking strength 405
Wound complication 336, 338
Wound infection 109, 136
– Rates 336
Wound oxygen levels 89
Wound tissue oxygenation 89
Wrap herniation 414, 416

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