Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05919836

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).

Condition or Disease	Intervention/Treatment	Phase
Congenital Inguinal Hernia	Procedure: Laparoscopic assisted hernia Procedure: Laparoscopic hernia by purse string closure Procedure: Total laparoscopic dissection of hernial sac	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Operative time [4 months]
Comparison between operative time in the three approaches
Early recurrence [4 months]
Comparison between early recurrence of hernia in the three approaches
Post operative pain duration [4 months]
Comparison between post operative pain duration between the three approaches

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mario Ayoub Youssef Sorial, Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05919836

Other Study ID Numbers:

lap hernia in pediatrics

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hernia

Hernia, Inguinal

Study Results

No Results Posted as of Jun 26, 2023