Laparoscopic Repair of Pediatric Inguinal Hernia Copy 2
Laparoscopic Repair of Pediatric Inguinal Hernia Copy 2
Laparoscopic Repair of Pediatric Inguinal Hernia Copy 2
By
Mostafa Sameh Ahmed El Deep
M.B.B.Ch., (2021)
Resident of Pediatric Surgery,
Faculty of Medicine, Suez Canal University
Supervisors:
Title Name Job Title University
Prof. Tarek Abdulazim Professor of Pediatric Faculty of
Dr. Gobran - Surgery Medicine -
Zagazig
University
DR. Ahmed Sobh Ahmed Lecturer of Pediatric Faculty of
darwish surgery Medicine, Suez
Canal University
DR. Ahmed Mahmoud Lecturer of Pediatric Faculty of
Moubarak surgery Medicine, Suez
Canal University
Faculty of Medicine
Suez Canal University
2024
Faculty of medicine
“Thesis Research Protocol”
Submission Date:
1
ABSTRACT
Introduction: Many techniques have been described for the treatment of
pediatric inguinal hernia (PIH). Some authors emphasized the
importance of disconnecting the sac, to create a scar, and to close the
peritoneum mimicking the open approach. Others stated that peritoneal
disconnection alone is enough for treatment of PIH regardless of the size
of the internal ring.
Aim of the study: To compare the short-term outcomes of laparoscopic
hernial sac disconnection and closure without sac excision against
hernial sac excision children in terms of feasibility, surgical details,
recurrence rate, and postoperative complications
Materials and methods:
The study will be carried from July 2024 to March 2025, on 34 patients
with Inguinal Hernia in each group. Patients will be randomly divided
into two groups: group A, subjected to laparoscopic hernial sac
disconnection and closure without sac excision and group B, subjected
to laparoscopic hernia sac disconnection with hernial sac excision. Both
groups will be compared regarding the operative details, including
complications and conversion, postoperative complications and
recurrence.
Expected Outcomes: Evaluation of the most effective technique to
repair hernias in children which will help to improve operative time and
reduce intra & postoperative complications.
Keywords: laparoscopic, pediatric, hernia repair, sac disconnection
2
Introduction and Background
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Open inguinal hernia repair can be performed under caudal block or
laryngeal mask anesthesia, however laparoscopic surgery requires
controlled general anesthesia and endotracheal intubation. Also,
throughout the learning curve, laparoscopic surgery takes longer than
open repair. (Shehata et al., 2018)
However, it has not attained the widespread acceptability observed
with other treatments, such as laparoscopic cholecystectomy, which may
be related to concerns that recurrence rates are higher than those for open
surgery, offsetting any possible benefits. (Raveenthiran & Agarwal.
2017)
Several procedures have been documented, including the use of extra-
or intracorporeal knotting and high ligation with or without peritoneal
disconnection at the internal ring. The intra-corporeal procedure involves
closing the internal ring with an intra-corporeal suture, typically using
three ports. The extra-corporeal approach employs a number of trocars,
ranging from one to three, together with a pre-peritoneal suture.
(Elbatarny et al., 2020)
Laparoscopic disconnection of the hernial sac with peritoneal closure
and sac excision over the internal ring was reported as a way to
replicate the open procedure and reduce the likelihood of recurrence.
(Bin Nour et al., 2023)
Disconnecting the hernial sac without sac excision is a successful
treatment for hernias with a small internal ring diameter (IRD) of less
than 10 mm, according to certain publications. Others concluded that
disconnection without sac excision is effective in larger rings of up to
20 mm, regardless of the interior ring size. (Nour et al., 2023)
4
The reason behind conducting this study is to compare the short-term
outcomes of laparoscopic hernial sac disconnection and closure without
sac excision against hernial sac excision children in terms of feasibility,
surgical details, recurrence rate, and postoperative complications
5
Research question:
Null hypothesis:
• There are no differences between laparoscopic repair of inguinal
hernia with Disconnection of the Hernial Sac versus Sac Excision
Aim
• To compare the short-term outcomes of laparoscopic hernial sac
disconnection and closure without sac excision against hernial sac
excision children in terms of feasibility, surgical details,
recurrence rate, and postoperative complications
Objectives
Primary objective:
• To evaluate the effectiveness of laparoscopy in the treatment of
inguinal hernias among pediatrics including technical
refinements and operative time.
6
Secondary objectives:
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Research Design and Methods
Study design:
Study population:
All patients will be enrolled to participate in the current study and each
parent or legal guardians will sign written consent
Sampling technique:
It will be consecutive sampling.
Inclusion criteria:
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Exclusion criteria:
• Infants and children with: incarcerated PIH, recurrent PIH,
patients with undescended testis, patients with chronic
comorbidity—such as congenital heart disease and severe chest
troubles—and patients with chronic cough or chronic
constipation.
Expected Outcomes
9
Statistical plan
Sample size:
• n= sample size
• Z α/2 = 1.96 (The critical value that divides the central 95% of
the Z distribution from the 5% in the tail)
• p = Prevalence of Congenital Hernia in Egypt = 5%
(Jessula S, et al., 2018)
10
Data Collection:
All patients will be subjected to the following:
Structured interview-based Questionnaire: will be used after obtaining
informed consent from each parent or legal guardians.
*pre-operative assessment:
Data will be collected from all patients using a simple self-designed
questionnaire by the researcher and the pre-operative data collected
included:
• Name, age and gender.
• Type of the hernia
• History of previous operations, and history of recurrence.
• Physical examination of the hernia.
• Exclusion of other congenital anomalies.
• Complete blood count, INR and PTT.
• US to detect the size of the defect and measure the contralateral side
ring. (A contralateral ring with width more than 5 mm is considered
patent processus vaginalis and will be compared with the surgical
findings).
*Procedure: -
-Anesthesia and preparation:
Patients are kept Nil by mouth for at least 6 hours prior to the surgery
except for breast feeding (4 hours) and clear liquids (2 hours). All
patients will have general anesthesia. Induction is done by inhalation of
Sevoflurane with a secured IV line. Then intubation with appropriate
ETT is done. Then O2 and Isoflurane inhalation are given. Muscle
relaxant is given with controlled ventilation. Third generation
cephalosporin is given intravenously as a 50mg/kg bolus before the start.
Caudal regional anesthesia with Bupivacaine is used.
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-Position and ergonomics:
The surgeon is positioned at the head of the patient, and the camera
operator is contralateral to the side of pathology. The video column is
positioned at the patient’s feet. The patient is placed in a supine position
with a 15°– 20° Trendelenburg inclination of the operative table to reduce
the abdominal contents. The average intra-abdominal pressure is 6–8
mmHg in patients under 1 year of age and 8–10 mmHg in older children.
The bladder will be emptied before beginning of the operation. Patients
under 1 year of age are placed trans table position for a better work
ergonomics.
-Steps:
1- One 5-mm trocar is inserted through the umbilicus. Through this
trocar, a 30-degree angled laparoscope is placed and a pneumoperitoneum
is maintained at 8–10 mmHg with a CO2 flow rate of 1– 2 L/min.
2- Bilateral internal inguinal rings are checked carefully for assurance of
indication and exploring the competence of the other inguinal ring.
3- Two further 3-mm trocars are inserted through separate stab incisions
in the lateral border of the rectus muscles at midclavicular lines.
4- The dissection started by using a dissector and scissors. The sac is
everted and the initial cut is done above the internal inguinal ring in the
parietal peritoneum.
5- Then, the dissection is carried out by separating the hernia sac from the
vascular structures and the vas in males.
6- The needle of the suture is inserted inside of the abdominal cavity
through right side trocar by laparoscopic needle holder with 3-0 Vicryl.
7- A purse-string suture is placed as in the peritoneum at the level of the
internal inguinal ring taking only the peritoneum leaving the distal sac
remnant in-situ.
8- In larger hernias (>4-5mm), add one or more interrupted stitches
between the conjoined tendon and crural arch to narrowing the internal
ring.
9- The same steps will be repeated in the contralateral internal inguinal
ring in case of bilateral inguinal hernia.
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*Intraoperative data collection:
1- Presence of contralateral patent processus vaginalis.
2- Injury to any vital structure.
3- Name of the operator.
4- Time of the surgery approximated in minutes (any time more than 30
seconds is added as a minute).
*Post-operative recovery:
Patients are starting oral feeding of soft diet 2 hours after complete
recovery and they are discharged home after 4 hours.
*Post-operative follow-up:
Follow up is done for 6 months.
1- The first visit will be 7 days postoperative.
2- The second visit will be 30 days postoperative.
3- A third visit will be after 3 months and a last visit by the 6th month.
*During the follow up period we detect any of the following:
• Hematoma of the testis or the cord. (Early complication)
• Edema of the testis or the cord. (Early complication)
• Recurrence. (Late complication)
• Hydrocele. (Late complication)
• Port-site hernia. (Late complication)
• Testicular atrophy. (Late complication)
• Ascending testis. (Late complication)
13
Data analysis:
• Statical analysis will be performed using the statistical package
for the Social Sciences (SPSS) program.
• Data will be presented as tables and graphs as appropriate.
• Quantitative data will be expressed as mean and standard
deviation while qualitative data will be expressed as number and
percentage.
• Comparisons will be performed using T test (for quantitative
data) and chi square (for qualitative data).
• Significance will be considered at p value of < 0.05.
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Ethical consideration:
* Data are collected after permission of the responsible authorities; Chief
of Surgery Department, Chief of Clinical Department and Ethics
committee.
• Written informed consent is obtained from all parents, or legal
guardians, after full explanation of hazards and benefits of the
management procedures that will be performed for each patient before
starting field work.
• Patients‟ guardians are notified about the study and the informative
written consent will be obtained prior to participation in the study.
• The aim of the study and the methods used in the research, possible
complication and other surgical options are reviewed with each patient
prior to participation.
• Confidentiality of the patients are maintained through the duration of
the research.
• Any patient refuses to participate in the study will not be enrolled in the
study (but surgical intervention will be done without including the results
in the study).
• Personal data of the participants are secretly treated.
• Patients are provided written consent for the use of their images.
• The patient has the right to withdraw from the study at any time with
neither jeopardizing the right of the patient to be treated nor affecting the
relationship between the patient and care provider.
• There are no similar researches currently going on in the Surgery
Department.
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Time Plan
May Jun July Aug Sep Oct Nov Dec Jan Feb March
Item
2024 2024 2024 2024 2024 2024 2024 2024 202 2024
2024 4
Protocol
writing
Literature
review
Data collection
Data analysis
Thesis
preparation
Review &
Thesis
presentation
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References:
• Bin Nour, S. M., Rozeik, A. E., Alekrashy, M., & El-Taher, A.
K. (2023). Laparoscopic techniques for congenital inguinal hernia
repair. Journal of Pharmaceutical Negative Results, 14(3).
• Chang SJ, Chen JYC, Hsu CK, et al. (2016) The incidence of
inguinal hernia and associated risk factors of incarceration in
pediatric inguinal hernia: a nation-wide longitudinal population-
based study. Hernia.; 20:559–563.
• Charan, J. and Biswas, T. (2013), “How to Calculate Sample Size
for Different Study Designs in Medical Research?”, Indian Journal
of Psychological Medicine, Indian Psychiatric Society South Zonal
Branch, Vol. 35 No. 2, p. 121.
• Elbatarny, A. M., Khairallah, M. G., Elsayed, M. M., & Hashish,
A. A. (2020). Laparoscopic repair of pediatric inguinal hernia:
disconnection of the hernial sac versus disconnection and peritoneal
closure. Journal of Laparoendoscopic & Advanced Surgical
Techniques, 30(8), 927-934.
• Jessula S, Davies DA. (2018) Evidence supporting laparoscopic
hernia repair in children. Curr Opin Pediatr.; 30(3):405-10.
• Mohammad, G., Mostafa, M., HASHISH, A. A., & AKRAM,
M. E. (2018). Laparoscopic Repair of Pediatric Inguinal Hernia by
Disconnection of the Hernial Sac. The Medical Journal of Cairo
University, 86(September), 3223-3229.
• Nour, S. M. B., Rozeik, A. E., Alekrashy, M., & El-Taher, A. K.
(2023). Laparoscopic Pediatric Inguinal Hernia Repair with and
without Excision of the Hernial Sac. The Egyptian Journal of
Hospital Medicine, 90(2), 2520-2525.
• Petridou, M., Karanikas, M., & Kaselas, C. (2023).
Laparoscopic vs. laparoscopically assisted pediatric inguinal hernia
repair: a systematic review. Pediatric Surgery International, 39(1),
212.
• Raveenthiran, V., & Agarwal, P. (2017). Choice of repairing
inguinal hernia in children: open versus laparoscopy. The Indian
Journal of Pediatrics, 84, 555-563.
• Shehata, S. M., Attia, M. A., Attar, A. A. E., Ebid, A. E.,
Shalaby, M. M., & ElBatarny, A. M. (2018). Algorithm of
laparoscopic technique in pediatric inguinal hernia: results from
17
experience of 10 years. Journal of Laparoendoscopic & Advanced
Surgical Techniques, 28(6), 755-759.
18
11. Appendices:
Study Questionnaire: -
Contact information
Name:
Age: Parent mobile:
Residency: Gender: Male Female
Preoperative assessment
Type: Bilateral Recurrent
Congenital anomalies: Yes No
Intraoperative data
Contralateral hernia: Yes No
Injury: Yes No
Operative time: minutes
Postoperative follow-up
No complications Edema Hematoma Recurrence
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نموذج الموافقة المستنيرة ألجراء بحث
طبي على مشارك متطوع
عنوان البحث:
إصالح الفتق اإلربي بالمنظار لدى األطفال :فصل كيس الفتق مقابل استئصال الكيس في
مستشفيات جامعة قناة السويس ،اإلسماعيلية
الخلفية العلمية والهدف من أجراء البحث:
الفتق اإلربي عند األطفال ( )PIHهو حالة جراحية منتشرة ،وهو ما يمثل ٪15من ممارسة جراحة األطفال .تم
االعتراف باإلصالح المفتوح التقليدي للفتق اإلربي باعتباره العالج القياسي الذهبي لـ PIHنظ ًار النخفاض معدل اإلصابة بالمرض،
والتجميل الجيد ،وانخفاض معدالت التكرار .ومع
ذلك ،خالل العقدين الماضيين ،مع تقدم جراحة التدخل الجراحي البسيط لدى األطفال (،)MIS
أصبح تنظير البطن أكثر شيو ًاعلعالج فرط التصبغ األولي.
يحدث الفتق اإلربي الخلقي (غير المباشر) في %2إلى %5من الولدان الناضجين ،مع نسبة
الذكور إلى اإلناث .1 :4.2يعد معدل اإلصابة عند الخدج أعلى بكثير ويعتمد على عمر الحمل،
٪60عند الرضع منخفضي وزن الوالدة للغاية .في ٪11ويقترب من ويتراوح من ٪9إلى
المظاهر السريرية ،يحدث %60من حاالت الفتق في الجانب األيمن ،و %25إلى %30على
الجانب األيسر ،و %10إلى %15في الجانب األيسر.
الفوائد المتوقعة من البحث:
• تقييم التقنية األكثر فعالية إلصالح الفتق عند األطفال والتي ستساعد على تحسين وقت العملية
وتقليل المضاعفات أثناء وبعد العملية الجراحية.
المخاطر المحتمل حدوثها من اجراء هذا البحث:
ال توجد مخاطر سلبية محتمل حدوثها جراء تلك الدراسة.
البدائل المتاحة :في حالة رفضك االشتراك في هذا البحث ستتلقى عالجك المعتاد .سرية المعلومات :سوف
تعامل معلوماتك بسرية كاملة ولن يطلع على بياناتك سوى الباحث الرئيسي .بعد انتهاء الدراسة سيتم إبالغك بنتائج البحث كما سيتم
إبالغك بأي نتائج تتعلق بحالتك
الصحية خاصة.
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حقك في االنسحاب :من حقك االنسحاب من البحث في أي وقت دون ابداء أسباب دون أي
عواقب سلبية عليك.
:عند وجود أي استفسار لديك يمكنك االتصال ب
التليفون: اسم الباحث الرئيسي :مصطفى سامح أحمد
التليفون: مقر لجنة األخالقيات :كلية الطب جامعة قناة السويس
أقر أنني أطلعت وفهمت االجراءات التي ستتم من خالل هذا البحث ووافقت عليها
. الباحث الرئيسي . المشارك في البحث
االسم:
التوقيع (البصمة):
التاريخ:
ملحوظة:
-1من حقك الحصول على صورة من اإلقرار.
-2هذا البحث توطئة لرسالة الدكتوراه.
تمت الموافقة على هذا البحث من قبل لجنة أخالقيات البحوث الطبية ..................
بتاريخ .....................هذه الموافقة سارية حتى
خاتم اللجنة :رئيس اللجنة:
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شششش شششششش
كلية الطب جامعة قناة مدرس جراحة األطفال أحمد محمود مبارك مدرس
السويس
1