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Completed

NCT Number: NCT04970160

Rectovestibular Fistula Which Surgical Approaches?

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.

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Key information

Conditions

Vestibular Fistulae Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

6 month–12 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TSARP

Procedure

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

Other names: Transfistula anorectoplasty TFARP

PSARP

Procedure

Posterior sagittal anorectoplasty

Other names: Posterior sagittal anorectoplasty

Classic ASARP

Procedure

Anterior Sagittal anorectoplasty

Other names: Anterior Sagittal anorectoplasty

Modified ASARP

Procedure

External anal sphincter preservation

Other names: External anal sphincter preservation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Acronym: Vestibanus

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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