Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprung's Disease

May 20, 2024 updated by: Ahmed Elrouby, Egyptian Biomedical Research Network

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 12345
        • Ahmed El Rouby

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
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

* Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy.

Exclusion Criteria:

  • Patients with previous colostomy.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT)
Procedure: Group A: Pure transanal endorectal pull-through (TAERPT)
Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy
Active Comparator: Group B
Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT)
Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)
Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative constipation
Time Frame: One post-operative year
The two groups will be compared according to post-operative constipation whether present or not
One post-operative year
Post-operative soiling
Time Frame: One post-operative year
The two groups will be compared according to post-operative soiling whether present or not
One post-operative year
Post-operative enterocolitis
Time Frame: One post-operative year
The two groups will be compared according to post-operative enterocolitis whether present or not
One post-operative year
Post-operative complications
Time Frame: One post-operative year
The two groups will be compared according to post-operative complications whether present or not
One post-operative year
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)
One post-operative year

Collaborators and Investigators

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

Sponsor

Egyptian Biomedical Research Network

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 (Actual)

January 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0306356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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