Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

June 16, 2023 updated by: Mario Ayoub Youssef Sorial, Assiut University
Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In pediatric age, indirect inguinal hernia represents more than 95% of the hernial disease. It is a congenital type, in contrast with adulthood in which acquired forms are more frequently found.

Inguinal hernia repair is one of the most frequently performed surgical procedure in infants and young children. Laparoscopic hernia repair in infancy and childhood is still debatable. There are many techniques available for laparoscopic hernia repair in pediatrics.

Laparoscopic hernial repair is increasingly adopted even for neonates and has achieved a high success rate with low recurrence rate with long-term follow-up. The main advantages of laparoscopy are no incision of the fascia, exploration of the other side in case of bilateral hernia, and visualization and safeguarding of the vas deferens and the spermatic vessels. Moreover, it is advantageous over open technique in case of recurrent hernia. Different modalities of techniques have been used for repair such as needlescopic disconnection of hernia sac, flip flap technique, muscular arch repair, and ring closure.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients in the age limit with congenital inguinal hernia

Exclusion Criteria:

  • recurrent hernias
  • cases inwhich laparoscopic surgery is contraindicated
  • cases with collagen defect diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous assisted laparoscopic hernia
Procedure: Laparoscopic assisted hernia
Percutaneous assisted laparoscopic hernia
Active Comparator: Laparoscopic Purse string closure of hernial sac
Procedure: Laparoscopic hernia by purse string closure
Laparoscopic purse string closure of hernial sac
Active Comparator: Laparoscopic Total dissection of hernial sac
Procedure: Total laparoscopic dissection of hernial sac
Total laparoscopic dissection of hernial sac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 4 months
Comparison between operative time in the three approaches
4 months
Early recurrence
Time Frame: 4 months
Comparison between early recurrence of hernia in the three approaches
4 months
Post operative pain duration
Time Frame: 4 months
Comparison between post operative pain duration between the three approaches
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lap hernia in pediatrics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Inguinal Hernia

Clinical Trials on Laparoscopic assisted hernia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe