Name of the P.G. College GRANT GOVT.

MEDICAL COLLEGE,
MUMBAI
Department GENERAL SURGERY
Name of the Candidate Dr. BALAMURUGAN G.
Name of the guide Dr. AJAY H. BHANDARWAR
Contact number of Candidate 9688631691
Contact number of Guide 9869039609

Through Proper Channel Only

To
The Registrar,
MUHS, Nasik.
Sub - Submission of title of synopsis.
Respected sir/madam,
I Dr. BALAMURUGAN G. registered for M.S. GENERAL SURGERY in the 2019-2020
batch under the guidance of Dr AJAY H. BHANDARWAR Head of the Department,
Department of General Surgery, GMC and JJ group of Hospitals, Byculla, Mumbai.
I am due to appear for M.S. GEN SURGERY in 2022.
I am submitting herewith the title of synopsis as mentioned below and as suggested by my
aforesaid guide
Title of Synopsis –

‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF

DIAPHRAGMATIC EVENTRATION STAPLED ALONE VERSUS
COMBINED STAPLER WITH PLICATION’
Kindly accept and register my title of synopsis.

Dr. AJAY H. BHANDARWAR Dr.BALAMURUGAN G.

(Guide name and signature) (Candidate’s name and signature)

Dr. AJAY H. BHANDARWAR

(Head of Department of General Surgery)
 Dr. BALAMURUGAN G.
Post graduate student
M.S. GENERAL SURGERY
Department of General Surgery
Grant Government Medical College
Date -

To,
The Chairman,
Institution Ethical committee,
Grant Medical College,
Mumbai 400 008

Through Proper Channel

Subject - An application for approval of dissertation topic by Ethical Committee.

Respected Sir/Madam,

I propose to do dissertation on the topic titled -

‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF DIAPHRAGMATIC

EVENTRATION STAPLED ALONE VERSUS COMBINED STAPLER WITH
PLICATION’

Under the guidance of Dr. AJAY H. BHANDARWAR, my postgraduate guide, Head of

Department, Department of General Surgery.
I request you to grant me permission to pursue this study. Please find enclosed herewith the
following documents--
1. Introduction.
2. Aims and Objectives.
3. Case selection.
4. Materials and Method.
5. Study Proforma.
Looking forward for your kind approval.

Thanking you in anticipation.

Yours faithfully,

Dr AJAY H. BHANDARWAR Dr. BALAMURUGAN G.

(PG Guide) (PG Student)
 REPORT OF ETHICS COMMITTEE
Department GENERAL SURGERY
Candidate admitted year 2019
Course and subject M.S. GENERAL SURGERY
College name and address Grant Medical College and Sir J.J. Group of
Hospitals Byculla, Mumbai 400 008

Reference No...................

To,
Dr. BALAMURUGAN G.
Post graduate student,
Department of general surgery,
Grant medical college,
Mumbai 400 008

Sub - Research Proposal of entitled

‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF DIAPHRAGMATIC

EVENTRATION STAPLED ALONE VERSUS COMBINED STAPLER WITH
PLICATION’

Reference -......................................

Dear student,

The above mentioned research proposal of title of synopsis was discussed in the ethic committee
held on......................................... At our college.

Ethics committee has unanimously approved you title of synopsis. This work will be done
under the guidance and supervision of your guide Dr. AJAY H. BHANDARWAR

Signature
Name -
Chairperson, Ethics Committee,
Grant Medical College, Mumbai
 SYNOPSIS

‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF

DIAPHRAGMATIC EVENTRATION STAPLED ALONE VERSUS
COMBINED STAPLER WITH PLICATION’
‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF
DIAPHRAGMATIC EVENTRATION STAPLED ALONE VERSUS
COMBINED STAPLER WITH PLICATION’

Plan of work for Research Project

Submitted to

MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK

By

DR. BALAMURUGAN G.
MBBS
Post graduate student,
Department of General Surgery,
Grant Govt. Medical College and Sir J.J. Group of Govt. Hospitals, Mumbai.

Under the guidance of

DR. AJAY H. BHANDARWAR

Postgraduate Guide
HEAD OF DEPARTMENT, Department of General Surgery,
J.J. GROUP OF HOSPITALS.
 GENERAL INFORMATION

TITLE -

‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF DIAPHRAGMATIC

EVENTRATION STAPLED ALONE VERSUS COMBINED STAPLER WITH
PLICATION’

Post Graduate Guide: DR. AJAY H. BHANDARWAR

Head of Department
Department of General Surgery
Grant Government Medical College and
Sir J.J. Group of Govt. Hospitals,
Byculla, Mumbai.

Post Graduate Student: DR. BALAMURUGAN G.

PG Student
Department of General Surgery
Grant Government Medical College and
Sir J.J. Group of Govt. Hospitals,
Byculla, Mumbai.

SIGNATURE OF:
I) PG STUDENT
Department of General Surgery
Grant Govt. Medical College, Mumbai ____________________________

II) PG GUIDE
Department of General Surgery
Grant Govt. Medical College, Mumbai ____________________________

III) PROFESSOR AND HEAD

Department of General Surgery
Grant Govt. Medical College, Mumbai ____________________________
Date of submission to Ethical Committee:

Date of Clearance from Ethical Committee:

Remarks by Chairman of Ethical Committee:

PROJECT SUMMARY -

Title of Dissertation -
‘COMPARATIVE STUDY IN THORACOSCOPIC REPAIR OF DIAPHRAGMATIC
EVENTRATION STAPLED ALONE VERSUS COMBINED STAPLER WITH
PLICATION’

No. of Subjects – minimum of 35 patients

Since the incidence of Diaphragmatic Eventration is < 0.05 %, this study includes both
retrospective and prospective cases

Study Duration -

1. Duration for collection of data – 16 months

2. Deadline for collection of data - July 2021

3. Period required to analyze data - 3 months

4. Deadline for submission of dissertation – December 2021

 INTRODUCTION

• Minimally invasive surgeries have recently seen tremendous development and have
revolutionized the field of surgery.
• Reduced post op morbidity, shorter hospital stay, reduced overall cost and earlier return
to normal activity have made them as the most preferred modalities.
• Video Assisted Thoracoscopic Surgery, Introduced by Jacobeus in 1913, is one such
minimally invasive technique in the field of thoracic surgeries.
• VATS avoids the morbid formal 6 to 10 inch thoracotomy incision and instead 2-4, < 1
inch each incisions are used.
• VATS provide adequate visualization despite limited access allowing the procedure to be
performed in the patients with limited pulmonary reserve & minimizing the
complications associated with thoracotomy incision. [1]

Eventration of diaphragm:

• Eventration of diaphragm is a rare anomaly defined by a permanent elevation of a

hemidiaphragm without defects; the muscular insertion are normal, the normal apertures
are sealed, and there is no interruption in the pleural and peritoneal layers.
• The terms eventration and paralysis are often confused; paralysis may be the instigator of
eventration because of degenerative muscular changes after denervation, whereas
eventration is not always associated with paralysis.
• The eventration may be partial or total, the partial eventration often being difficult to
distinguish from hernia.
• Eventration may be congenital or acquired.
• Left sided eventration is more common.
• In the order of frequency the symptoms are dyspeptic, respiratory and cardiac. [2]
 REVIEW OF LITERATURE

• Video assisted thoracoscopy is now a well-established technique in the armamentarium

of the thoracic surgeon. Before the 1990s thoracoscopic surgery was restricted to biopsy
procedures, management of pneumothorax, empyema irrigation, sympathetic chain
ablation, and removal of intrathoracic foreign bodies.
• The introduction of video imaging technology and the wider availability of stapling
devices facilitated an increasingly wider use of thoracoscopy for diagnostic and
therapeutic procedures. [3]
• Routine VATS is a safe procedure. It adds little to the overall cost or operating time; it
can provide useful information that could alter subsequent operative strategy. [4]
• Eventration of diaphragm is generally regarded as a condition in which the left or the
right leaf of the diaphragm has ascended abnormally high into chest. In rare cases both
leaves are elevated.
• The eventration may be total or partial, the partial eventration often being difficult to
distinguish from a hernia. [5]
• The movements of the diaphragm synchronize, but the right moves much better than the
left.

AIM

• This study aims to compare the outcomes of Stapled Repair of Diaphragmatic

Eventration alone versus Outcome of Stapled and Plication combined.

OBJECTIVES -

To evaluate stapled resection alone v/s stapled with plication in management of diaphragmatic
eventration, in terms of the following-
• The degree of lung expansion (as evaluated by post op chest X-rays) and relief of
symptoms
• Intraoperative time required between the two methods
• To combine the use of conventional intra-corporeal suturing and endo-stitch in
thoracoscopic plication
• Post-operative analgesia needed and Visual Analogue Score.
• Total duration of hospital stay & days away from work
• Post-operative complications, recurrence if any
END POINTS OF STUDY -

1. 1-year post-operative or mortality whichever is earlier.

TYPE OF STUDY -

Retrospective & Prospective comparative Study

METHODS AND MATERIALS -

● Research site – Tertiary Care Hospitals

● Sample size – minimum of 35 patients. Since the incidence of Diaphragmatic Eventration

is < 0.05 %, this study includes both retrospective and prospective cases

● Mode of Selection – Patients presenting in Out-Patient Department and In-Patient

Department who meet the inclusion criteria and do not possess any exclusion criteria.
Patients who consent to be a part of the study.

REQUIREMENTS FOR STUDY:

● Standard Laparoscopic instruments

● Laparoscope set
● Thoracoscopic ports
● Non-absorbable Barbed sutures / Unbarbed sutures,
● Endostaplers

● Quality of life assessment – 36 Item Short Form Survey Instrument shall be utilized for
Quality of Life Assessment.
PATIENT SELECTION -

● Inclusion Criteria –

1.Patients who are clinically symptomatic from Eventration of diaphragm

2.Patients who consent to undergo the procedure
3.Patients older than 18 years of age
4.Patients lesser than 65 years of age

● Exclusion Criteria –

1.Patients suspected of suffering from malignant diseases

2.Markedly unstable or poor on ECOG/ Karnofsky performance scale patients.
3.Patients with chest wall abnormalities
4.Pregnancy
5.Patients under 18 years of age
6.Patients older than 65 years of age
7.Patients who are not fit for General Anaesthesia

METHODOLOGY AND TECHNIQUES -

It is a longitudinal study to be conducted on patients presenting with Eventration of diaphragm at

a tertiary care hospital.

The material for the study of management of Eventration of diaphragm is to be collected from
cases admitted to various surgical wards in a Tertiary Care Government Hospital.

During the period of approval from ethics committee to July 2021, at least 35 cases of
Diaphragmatic eventration are to be studied with age 18-65 years.

Patient data will be collected according to information in case record sheet. Intra-operative
findings will be noted. Regular follow up will be maintained until at least 1-year post operatively.
● Patients' data will be collected in a case record sheet
● Pre-operative Quality of Life Parameters will be assessed
● Pre-operative Imaging such as X-ray Chest, USG, HRCT, MRI and Pulmonary
Function Tests will be taken into consideration
 ● Intra-operative findings will be noted, including:
1. Duration of surgery
2. Any intra-operative difficulty encountered
3. Pressure used intra operatively
• If abandoned, reason for it.

 Post-operative findings will be noted:

1. Day of starting oral feeds

2. Need of post-operative analgesia
3. Day of ICD removal
4. Duration of post-operative hospital stay
5. Reduction of symptoms
6. Duration of post-operative recovery time
7. Need for repeat procedures and recurrence

• Follow-up will be maintained with respect to monthly routine chest x ray and
improvement in pulmonary function test in c/o symptoms for a period of 3 months and at
the end of 3rd month HRCT thorax.
 CASE RECORD FORM:
PATIENT DETAILS:

Name:
Age:
Sex:
Reg. No:
Ward:
Unit: ______
D.O.A: _____
D.O.P: _____
D.O.D: _____
Address:
Contact number: _______________________
Occupation: ___________________________
Chief complaints: ______________________________________________
History of O.D.P:
________________________________________________________________
Negative history: _________________________________________________
PAST HISTORY: _________________________________________________
1. Medical –
● DM and treatment
● HTN
● Asthma
● IHD
● Other systemic illness
2. Surgical- Any previous surgical intervention Yes ______ No _______
Personal history- Diet/Appetite/Bowel/Bladder:
Any addiction: __________________________________________________
Family history: __________________________________________________

GENERAL EXAMINATION
Febrile/Afebrile
Pulse: __________________________________________________
Blood Pressure: __________________________________________________
Respiratory Rate: __________________________________________________
Abdominal girth: __________________________________________________
Pallor/Icterus/Cyanosis/Lymphadenopathy/Clubbing/Edema
Body parameters
1. Weight(kg): _____________________
2. Height(cm): ___________________________
3. BMI: ________________________
SYSTEMIC EXAMINATION
1. Per Abdomen
2. Cardiovascular System
3. Respiratory System
4. Central Nervous System

INVESTIGATIONS
1. Hemoglobin
2. Complete Blood Count
3. Renal Function Tests
● Serum Creatinine
● Blood Urea
4. Liver Function Tests
● Serum Bilirubin
● SGOT (Serum Glutamate Ornithine Transaminase)
● SGPT (Serum Glutamate Pyruvate Transaminase)
● Total protein
● Albumin
● Globulin
5. Serum electrolytes
● Na+
● K+
6. Random blood sugar-
7. Serology
● ELISA and/or IHA for HIV, Hepatitis B (HBsAg) and Hepatitis C virus
8.Pulmonary Function Tests
9.Imaging
● XRAY CHEST PA,
● ECG
● USG Thorax, USG A + P
● HRCT Thorax
● MRI
●
CLINICAL DIAGNOSIS:

TREATMENT
Pre-op Medication_______________________________________

Post-op medication: __________________________________________________

Intra-op assessment -

1. Intra-op Time -
2. Intra-op pressure –
3. Intra-op complications encountered – Yes/ No
4.Type of suture material – Non-absorbable barbed/unbarbed
5. No. of Staplers used -
6. If procedure abandoned, reason -

Post-operative assessment -

1. Number of days for which post op analgesia was required: _________ days

2. Total duration of hospital stay: _________ days

3. No. of days taken leave from work: _________ days

4. Recurrence: Yes/No.
If yes, at _________ months

Visual analog scale for Post op pain monitorining

 METHODOLOGY AND STATISTICS

INFORMED CONSENT FORM

For submission of Research proposal to Ethics Committee

I, Mr./Mrs.____________________________________, age ______ years, residing

at___________ hereby give my informed consent to participate in the ‘COMPARATIVE
STUDY IN THORACOSCOPIC REPAIR OF DIAPHRAGMATIC EVENTRATION
STAPLED ALONE VERSUS COMBINED STAPLER WITH PLICATION’

1. There is no compulsion on me to participate in this project and I am giving my free

consent for it.
2. I am ready and willing to undergo all tests in the present project.
3. I have read and I have been explained the general information and purpose of the
present project.
4. I am aware that Thoracoscopic Repair of Eventration of diaphragm using staplers alone
and staplers with combined plication is available in the hospital and I freely choose both
methods in my case. It has been explained to me that the aforementioned procedure is now
well established as safe and reliable. However, a few possible complications that may arise
during the minimally invasive procedure such as injury to surrounding structures,
hemorrhage, post-operative pain etc. have been made clear to me.
5. In case during the course of surgery for any reason Thoracoscopic surgery cannot, in the
opinion of surgeon, be continued, I give free and full consent to the conversion of
procedure into open type operation.
6. I have been informed the probable complications while participating in the present
project.
7. I know that I can withdraw from the present project at any time.
8. Any data or analysis of this project will be purely used for scientific purpose and my
name will be kept confidential except when required for any legal purpose.
9. I can read English / I can understand data read out to me in English and will translate the
consent form in Hindi in case the patient does not understand English.

Signature of Volunteer Signature of relative

Witnesses:
1.
2.
 मममममम ममममममममम ममममम
मममम मममममममम मममममम मममममममम मममम
मममममममममम

मम, मममम ./Mrs.____________________________________, मम ______ ममममम,

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References
Additional References –

• [1]Loddenkemper R. Thoracoscopy-state of the art. Eur Respir J 1998;11:213±21

• [2]Jerome Mouroux, MD, Nicolas Venissac, MD, Franceso Leo, MD, Marco Alifano,
MD, Francoise Guillot, MD
• [3]Walker WS,Craig SR.Video-assisted thoracoscopic pulmonary surgery-current
status and potential evolution. Eur J Cardiothorac Surg 1996;10:161±7.
• [4]Carnochan FM, Walker WS, Cameron EWJ. Efficacy of video-assisted
thoracoscopic lung biopsy: a historical comparison with open lung biopsy.
• [5]Christensen P. Eventration of the diaphragm. Thorax 1959;14:311-9
• [6]Bayne-Jones, S., “Eventration of the diaphragm.” Arch. Inter. Med., 1916, xvii,
221-237