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

NCT06856304 | Completed DMC

• 1 other identifier: 0107373
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatrics; Inguinal Hernia Repair

Keywords

Laparoscopy; inguinal hernia; PIRS; sac disconnection; Narrowing of the internal ring

Outcome Measures

Primary Outcomes (3)

• operative time

  time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen

  the time estimated during the operation

• intraoperative safety

  injury of the vas deffernce , spermatic vessels , bleeding

  the time estimated during the operation

• Recurrence of the inguinal hernia

  postoperative swelling in the inguinal region with gurgling sensation

  1 year

Secondary Outcomes (1)

• cosmesis

  1 year

Study Arms (2)

Group A

EXPERIMENTAL

laparoscopic disconnection of the hernia sac and narrowing of the internal ring

Procedure: laparoscopic disconnection of the hernia sac

Group B

EXPERIMENTAL

Percautaneous internal ring suturing

Procedure: Percutaneous internal ring suturing

Interventions

laparoscopic disconnection of the hernia sac PROCEDURE

disconnection of the hernial sac at the level of the internal ring using hook diathermy with sweeping the vas and the vessels away till completely separating them from the edges of the sac, then narrowing of the internal ring by appling a vicryl 3/0 suture between the ilipubic tract and the transverse arch of the transversus abdominus muscle

Group A

Percutaneous internal ring suturing PROCEDURE

A single umbilical trocar was placed through a supraumbilical incision, and then the surgeon stood on the same side of the hernia. To choose the location for the needle puncture, the position of the IIR was assessed by pressing the inguinal region from the outside with the tip of a forceps. Under laparoscopic-guided vision, the previously prepared 18-gauge injection needle threaded with the monofilament suture was introduced into the abdominal wall through a skin puncture at the lateral edge of the internal ring. With the movements of the tip of the needle, the thread passed under the peritoneum, over the lateral half of the IIR. The thread was pushed through the barrel of the needle into the abdominal cavity and eventually made a loop. The needle was pulled out, leaving the loop of the thread inside the abdomen by hanging the loop on the endoscope this prevented the extraction of the loop with the needle and thus prevented repeating this step. Next, the thread loop was pulled out of t

Group B

Eligibility Criteria

• Age: 6 Months - 5 Years
• Gender Eligibility Details: only male patients were included
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 12345, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Abouheba, Assistant Professor

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 4, 2025
• Study Start: May 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2024
• Last Updated: March 4, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)