Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia

Not Applicable

Completed

• Conditions: Pediatrics; Inguinal Hernia Repair

• Registration Number: NCT06856304
• Lead Sponsor: Alexandria University

Brief Summary

Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Detailed Description

Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.

Materials and Methods: This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-09
• Primary Completion: 2023-05-30
• Study Completion: 2024-05-30
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 109

Inclusion Criteria

• male patients
• age of 6 month to 5years
• reduciable congenital inguinal hernia either unilateral or bilateral.

Exclusion Criteria

• incarcerated CIH
• recurrent CIH
• patients with undescended testis,
• patients with hydrocele,
• patients with chronic comorbidity such as congenital heart disease and severe chest troubles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operative time	the time estimated during the operation	time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen
intraoperative safety	the time estimated during the operation	injury of the vas deffernce , spermatic vessels , bleeding
Recurrence of the inguinal hernia	1 year	postoperative swelling in the inguinal region with gurgling sensation

Secondary Outcome Measures

Name	Time	Method
cosmesis	1 year	postoperative scar

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt