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

Not Applicable
Completed
Conditions
Pediatric Disorder
Hirschprung's Disease
Registration Number
NCT06419998
Lead Sponsor
Egyptian Biomedical Research Network
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria
  • Patients with previous colostomy.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Post-operative enterocolitisOne post-operative year

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

Post-operative complicationsOne post-operative year

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

Post-operative continenceOne 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 constipationOne post-operative year

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

Post-operative soilingOne post-operative year

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ahmed El Rouby

🇪🇬

Alexandria, Egypt

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