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Completed

NCT Number: NCT06419998

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

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.

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Key information

Conditions

Pediatric Disorder Hirschprung's Disease

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed El Rouby

Alexandria, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

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

Procedure

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

Primary outcomes

  1. 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)

  2. Post-operative constipation

    Time frame: One post-operative year

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

  3. Post-operative soiling

    Time frame: One post-operative year

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

  4. Post-operative enterocolitis

    Time frame: One post-operative year

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

  5. Post-operative complications

    Time frame: One post-operative year

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

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 17, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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