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

NCT ID: NCT06419998

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Pediatric Disorder Hirschprung's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT)

Group Type ACTIVE_COMPARATOR

Group A: Pure transanal endorectal pull-through (TAERPT)

Intervention Type PROCEDURE

Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy

Group B

Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT)

Group Type ACTIVE_COMPARATOR

Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)

Intervention Type PROCEDURE

Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Ahmed Elrouby

Associate Professor of pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed El Rouby

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Elrouby A, Shehata S, Waheeb S, Khairi A, AbdAl-Aziz D, Looka B. One stage transanal versus one stage laparoscopic-assisted transanal endorectal pull-through in managing Hirschsprung's disease in pediatric age group; a retrospective study. BMC Surg. 2025 Feb 8;25(1):59. doi: 10.1186/s12893-025-02768-1.

Reference Type DERIVED
PMID: 39922991 (View on PubMed)

Other Identifiers

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0306356

Identifier Type: -

Identifier Source: org_study_id

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