Laparoscopic Inguinal Hernia Repair in Infancy and Childhood

NCT02239185 | Completed

• 2 other identifiers: CTP-2014RAFIK-2014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study The aim of this study is to test the hypothesis that during laparoscopic hernia repair, disconnection of the hernial sac along with suture ligation of the neck is better than transperitoneal purse string suture around the hernial sac at the neck leaving the sac in continuity. Also to compare the two different laparoscopic techniques as regards operative time, recurrence rate, hydrocele formation, and other possible complications as bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic results. ..

Conditions

Congenital Inguinal Hernia

Keywords

Laparoscopy; purse string; hernial sac

Outcome Measures

Primary Outcomes (1)

• Recurrence

  All Patients will be subjected to post operative clinical examination and scrotal U/S for assessment of the recurrence. Recurrence is identified by visual of a bulg at the site of hernia on crying and the presence of defect more than 4 mm. In diameter

  At 3 and 6 months post operatively

Secondary Outcomes (2)

• Operative time

  intra operative time is measured from skin incision to skin closure

• Post operative hydrocele formation

  at 1 and 3 months post operatively

Study Arms (2)

Hernial sac ligation in continuity

OTHER

laparoscopic closure of hernia sac in continuity using 3 - 0 non-absorbable purse-string suture. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying.

Procedure: Hernial sac ligation in continuity

Hernial sac disconnection

OTHER

circumferential incision on the peritoneum at internal inguinal ring (IIR) with separation of hernia sac from the peritoneum. The proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.

Procedure: Hernial sac disconnection

Interventions

Hernial sac ligation in continuity PROCEDURE

Laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring.

Also known as: Purse string suture around IIR leaving the sac in continuity

Hernial sac ligation in continuity

Hernial sac disconnection PROCEDURE

Circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.

Also known as: Laparoscopic disconnection of the hernial sac at IIR

Hernial sac disconnection

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with questionable other side, parental request and cases with CIH associated with umbilical hernia.

You may not qualify if:

• Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental refusal, Contraindications for laparoscopy as lower major abdominal surgery

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Rafik Shalaby

Cairo, 11884, Egypt

Location

Related Publications (1)

• Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.

  PMID: 23326656 BACKGROUND

Study Officials

• Rafik MI Shalaby, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: September 12, 2014
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

EG (1)