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Rectovestibular Fistula Which Surgical Approaches? (Vestibanus)

A

Aswan University Hospital

Status

Completed

Conditions

Vestibular Fistulae

Treatments

Procedure: PSARP
Procedure: TSARP
Procedure: Classic ASARP
Procedure: Modified ASARP

Study type

Observational

Funder types

Other

Identifiers

NCT04970160
AswanUH2

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

Female

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.

Exclusion criteria

  • Exclusion criteria were patients with recurrence, previous anorectal surgery.
  • Patients with anovestibular fistulae.
  • Patients with rectoperineal fistulas.
  • Patients with cognitive impairment.

Trial design

84 participants in 4 patient groups

TSARP
Description:
Is a surgical procedure
Treatment:
Procedure: TSARP
ASARP classic
Description:
Surgical procedure
Treatment:
Procedure: Classic ASARP
PSARP
Description:
Surgical procedure
Treatment:
Procedure: PSARP
Modified ASARP
Description:
Surgical procedure
Treatment:
Procedure: Modified ASARP

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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