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

NCT06419998 | Completed

• 1 other identifier: 0306356
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Disorder; Hirschprung's Disease

Outcome Measures

Primary Outcomes (5)

• Post-operative continence

  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)

  One post-operative year

• Post-operative constipation

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

  One post-operative year

• Post-operative soiling

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

  One post-operative year

• Post-operative enterocolitis

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

  One post-operative year

• Post-operative complications

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

  One post-operative year

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

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

Group B

ACTIVE COMPARATOR

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

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

Interventions

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 A

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

Group B

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \* 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.

You may not qualify if:

• Patients with previous colostomy.

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Ahmed El Rouby

Alexandria, 12345, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39922991 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of pediatric Surgery

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)