Laparoscopic Percutaneous Extra-peritoneal Closure of the Internal Ring With or Without Peritoneal Cauterization

Outcome of Laparoscopic Percutaneous Extra-peritoneal Closure of Internal Ring With or Without Peritoneal Cauterization

This research project aims to evaluate pediatric patients who underwent laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Percutaneous Extra-peritoneal Closure; Internal Ring; Peritoneal Cauterization
• Intervention / Treatment: Procedure: Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization; Procedure: Percutaneous Internal Ring Suturing

Detailed Description

Inguinal hernia repair is the most common procedure performed by pediatric surgery trainees. Open hernia repair (OH) is considered the gold standard approach for children; however, laparoscopic repair (LR) has recently emerged as an alternative option.

Laparoscopic percutaneous extraperitoneal closure of internal inguinal ring (Laparoscopic Percutaneous Internal Ring Suturing) (PIRS) is one of the plainest and most dependable operations for pediatric inguinal hernia.

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective comparative cohort study, evaluating pediatric patients who underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia between [January 2023] and [December 2024].

Description

Inclusion Criteria:

• Pediatric patients (3 months to 12 years) with diagnosed inguinal hernia.
• Underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS).
• Clear documentation of whether cauterization was performed.
• At least 6 months of postoperative follow-up available.

Exclusion Criteria:

• Recurrent or complicated hernias (incarcerated/strangulated).
• Previous abdominal or pelvic surgery.
• Missing or incomplete surgical records.
• Less than 6 months of follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization at the internal ring.	Procedure: Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization; Percutaneous Internal Ring Suturing with peritoneal cauterization at the internal ring.
Group B; Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization.	Procedure: Percutaneous Internal Ring Suturing; Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of recurrence	Incidence of recurrence was recorded.	1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications	Incidence of postoperative complications such as seroma, hematoma, hydrocele, and wound infection were recorded.	24 hours postoperatively
Degree of pain	Degree of pain was assessed using Face, Legs, Activity, Cry, Consolability scale (FLACC) in patients <7 years, or using the visual analog scale (VAS)(0 represents "no pain" while 10 represents "the worst pain imaginable") in patients≥7 years.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: REC 713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No