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Clinical Trials/NCT06419998
NCT06419998
Completed
Not Applicable

One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study.

Egyptian Biomedical Research Network1 site in 1 country70 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Disorder
Sponsor
Egyptian Biomedical Research Network
Enrollment
70
Locations
1
Primary Endpoint
Post-operative enterocolitis
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old.

The main questions our study aims to answer are:

  • Does post-operative continence differs between the two groups?
  • Does post-operative constipation differs between the two groups?
  • Does post-operative soiling differs between the two groups
  • Does post-operative enterocolitis differs between the two groups?
  • Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications.

Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B.

Detailed Description

Introduction: One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material \& methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Egyptian Biomedical Research Network
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Elrouby

Associate Professor of pediatric Surgery

Egyptian Biomedical Research Network

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients with previous colostomy.

Outcomes

Primary Outcomes

Post-operative enterocolitis

Time Frame: One post-operative year

The two groups will be compared according to post-operative enterocolitis whether present or not

Post-operative complications

Time Frame: One post-operative year

The two groups will be compared according to post-operative complications whether present or not

Post-operative continence

Time Frame: One post-operative year

The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24)

Post-operative constipation

Time Frame: One post-operative year

The two groups will be compared according to post-operative constipation whether present or not

Post-operative soiling

Time Frame: One post-operative year

The two groups will be compared according to post-operative soiling whether present or not

Study Sites (1)

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