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

Egyptian Biomedical Research Network

Status: Completed

Conditions: Pediatric Disorder; Hirschprung's Disease

Treatments: Procedure: Group A: Pure transanal endorectal pull-through (TAERPT); Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06419998

0306356

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

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

Group B

Active Comparator group

Description:

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

Treatment:

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