NCT06975826

Brief Summary

To compare between the use of the percutaneous internal ring suturing (PIRS) technique and the Laparoscopic intraperitoneal purse-string suture sac closure technique. in pediatrics \& evaluate the safety, efficacy feasibility ,operative time ,postoperative pain ,recurrence rate of both approaches.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2025

Status
not yet recruiting

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 Progress68%
May 2025Oct 2026

First Submitted

Initial submission to the registry

January 26, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

January 26, 2025

Last Update Submit

May 8, 2025

Conditions

Keywords

Laparscopic inguinal herniotomy

Outcome Measures

Primary Outcomes (1)

  • Operative time in both approaches

    time from start of operation to the end

    baseline

Study Arms (2)

Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia

ACTIVE COMPARATOR

Use of laparoscopy in Management of inguinal hernia in pediatrics without entering peritoneal cavity

Procedure: Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia

Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics.

ACTIVE COMPARATOR

Use of laparoscopy in Management of inguinal hernia in pediatrics through entering peritoneal cavity

Procedure: Laparscopic inguinal herniotomy in pediatrics

Interventions

Laparscopic percutaneous internal ring suturing (PIRS) technique

Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia

Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics.

Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Age 1month to 18 years. 2. Denovo Inguinal Hernias. 3. Uncomplicated Inguinal Hernias.

You may not qualify if:

  • \. Complicated Inguinal Hernia 2. Age more than 18 Years 3. cases inwhich laparoscopic surgery is contraindicated 4. cases with collagen disease. 5. Recurrent Inguinal Hernia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Methods

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Almoataz Ahmed Eltayeb

    STUDY DIRECTOR

Central Study Contacts

Nour eldein Ali Thabet

CONTACT

Ahmed Gamal Abdelmalik

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 26, 2025

First Posted

May 16, 2025

Study Start

May 26, 2025

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05