Rectovestibular Fistula Which Surgical Approaches?

Completed

• Conditions: Vestibular Fistulae
• Interventions: Procedure: TSARP; Procedure: PSARP; Procedure: Classic ASARP; Procedure: Modified ASARP

• Registration Number: NCT04970160
• Lead Sponsor: Aswan University Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TSARP	TSARP	Is a surgical procedure
PSARP	PSARP	Surgical procedure
ASARP classic	Classic ASARP	Surgical procedure
Modified ASARP	Modified ASARP	Surgical procedure

Primary Outcome Measures

Name	Time	Method
Templeton score	1 year	The follow up period is up to one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (\<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score; . It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.

Secondary Outcome Measures

Name	Time	Method
Anal continence	1year	The assessment period is upto one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (\<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score3; . It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.