Clinical trial NCT04970160: Rectovestibular Fistula Which Surgical Approaches?
Official title: Rectovestibular Fistula Which Surgical Approaches?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Fistulae
Keywords: Vestibular anus,
Anal transposition,
Anorectal malformations
Transfistula anorectoplasty
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 84
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was a randomized, comparative trial involving female children suffering from vestibular fistula taken from among patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital from January 2016 to February 2020. The patients were randomly separated into four groups according to the procedure performed. The different procedures included were TSARP, PSARP, classic ASARP, and modified ASARP. Randomization did by copies the names of the techniques on four separate papers and then the surgeon was blindly chose one paper for each patient. Four pediatric surgeons had experience in ARMs techniques were performed the repair.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Templeton score
timeFrame: 1 year
Secondary outcomes:
measure: Anal continence
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: Aswan University
name: Sarah Abdelmohsen
role: PRINCIPAL_INVESTIGATOR
References: