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

NCT06419998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Pediatric Disorder
  • Hirschprung's Disease

Interventions

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

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

Sponsors & Collaborators

  • Egyptian Biomedical Research Network

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419998 on ClinicalTrials.gov