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Rectovestibular Fistula Which Surgical Approaches?

Rectovestibular Fistula Which Surgical Approaches?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04970160
Acronym
Vestibanus
Enrollment
84
Registered
2021-07-21
Start date
2016-01-01
Completion date
2020-02-28
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Fistulae

Keywords

Vestibular anus,, Anal transposition,, Anorectal malformations, Transfistula anorectoplasty

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.

Interventions

PROCEDURETSARP

We make four different surgical operations for female patients with rectovestibular fistula

PROCEDUREPSARP

Posterior sagittal anorectoplasty

PROCEDUREClassic ASARP

Anterior Sagittal anorectoplasty

PROCEDUREModified ASARP

External anal sphincter preservation

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
6 Months to 12 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Templeton score1 yearThe 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

MeasureTime frameDescription
Anal continence1yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026