Rectovestibular Fistula Which Surgical Approaches? (Vestibanus)

July 20, 2021 updated by: Magdy, Aswan University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

84

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TSARP
Is a surgical procedure
Procedure: TSARP
We make four different surgical operations for female patients with rectovestibular fistula
Other Names:
  • Transfistula anorectoplasty TFARP
ASARP classic
Surgical procedure
Procedure: Classic ASARP
Anterior Sagittal anorectoplasty
Other Names:
  • Anterior Sagittal anorectoplasty
PSARP
Surgical procedure
Procedure: PSARP
Posterior sagittal anorectoplasty
Other Names:
  • Posterior sagittal anorectoplasty
Modified ASARP
Surgical procedure
Procedure: Modified ASARP
External anal sphincter preservation
Other Names:
  • External anal sphincter preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Templeton score
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anal continence
Time Frame: 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.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Investigators

  • Principal Investigator: Sarah Abdelmohsen, Aswan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AswanUH2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe