Clinical trial NCT06419998: Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprung's Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Hirschprung's Disease
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2024-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Post-operative continence
timeFrame: One post-operative year
measure: Post-operative constipation
timeFrame: One post-operative year
measure: Post-operative soiling
timeFrame: One post-operative year
measure: Post-operative enterocolitis
timeFrame: One post-operative year
measure: Post-operative complications
timeFrame: One post-operative year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ahmed El Rouby
Study officials:
References: