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Clinical Trials/NCT07186647
NCT07186647CompletedPhase 4

Laparoscopic-Assisted Transanal Pull-Through for Hirschsprung Disease in Pediatric:Short and Intermediate Outcomes of Two Different Techniques

Al-Azhar University1 site in 1 country40 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
postoperative bowel function score

Study Overview

Brief Summary

Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD.

Detailed Description

A prospective, randomized study was conducted involving 80 patients diagnosed with HD at Al-Azhar University Hospitals over a 48-month period from September 2020 to August 2024. Participants were randomly allocated to the LASwL (Group A) or LASo (Group B). The primary outcome was the postoperative bowel function score. Secondary outcomes included operative time, blood loss, duration of hospital stay, and incidence of postoperative Hirschsprung-associated enterocolitis (HAEC).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
1 Month to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •infants and children diagnosed with Hirschsprung's disease (HD) at the Department of Pediatric Surgery, Al-Azhar University Hospitals, from September 2020 to August 2024

Exclusion Criteria

  • •Patients with ultrashort or total colonic aganglionosis and those who had previously undergone pull-through procedures

Arms & Interventions

Group B

Active Comparator

20 patients with HD

Intervention: laparoscopic-assisted Soave (LASo) (Procedure)

Group A

Active Comparator

20 patients with HD

Intervention: laparoscopic-assisted Swenson-like (LASwL) (Procedure)

Outcomes

Primary Outcomes

postoperative bowel function score

Time Frame: 2 years

This assessment evaluated the ability to hold back defecation, the ability to feel or report the urge to defecate, the frequency of defecation, soiling accidents, constipation, and social issues. Most items are scored on a 0-3 scale, while defecation frequency is scored 1-2, resulting in a maximum total score of 20. A higher score indicates better bowel function, with Scores ranged from 17-20 (excellent), 12-16 (good), 9-11 (fair), and less than 8 (poor)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdelmaboud

assistant professor

Al-Azhar University

Study Sites (1)

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