NCT07102277

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 28, 2025

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of recurrence

    Incidence of recurrence was recorded.

    1 year post-procedure

Secondary Outcomes (2)

  • Incidence of postoperative complications

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

Study Arms (2)

Group A

Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization at the internal ring.

Procedure: Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization

Group B

Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization.

Procedure: Percutaneous Internal Ring Suturing

Interventions

Percutaneous Internal Ring Suturing with peritoneal cauterization at the internal ring.

Group A

Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization.

Group B

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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 \[December 2024\].

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof. Pediatric Surgery Unit, Faculty of Medicine, Tanta University, Egypt.

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 3, 2025

Study Start

January 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations