Trials / Completed
CompletedNCT04970160
Rectovestibular Fistula Which Surgical Approaches?
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 84 (actual)
- Sponsor
- Aswan University Hospital · Academic / Other
- Sex
- Female
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
Detailed description
Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TSARP | We make four different surgical operations for female patients with rectovestibular fistula |
| PROCEDURE | PSARP | Posterior sagittal anorectoplasty |
| PROCEDURE | Classic ASARP | Anterior Sagittal anorectoplasty |
| PROCEDURE | Modified ASARP | External anal sphincter preservation |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2020-02-28
- Completion
- 2020-02-28
- First posted
- 2021-07-21
- Last updated
- 2021-07-21
Source: ClinicalTrials.gov record NCT04970160. Inclusion in this directory is not an endorsement.