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

Pediatric Disorder Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06419998
• Other study ID #: 0306356
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hirschprung's Disease
• Hirschsprung Disease
• Pediatric Disorder

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Ahmed El Rouby	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Post-operative constipation	The two groups will be compared according to post-operative constipation whether present or not	One post-operative year
Primary	Post-operative soiling	The two groups will be compared according to post-operative soiling whether present or not	One post-operative year
Primary	Post-operative enterocolitis	The two groups will be compared according to post-operative enterocolitis whether present or not	One post-operative year
Primary	Post-operative complications	The two groups will be compared according to post-operative complications whether present or not	One post-operative year