Rectovestibular Fistula Which Surgical Approaches?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rectovestibular Fistula Which Surgical Approaches?

Conditions
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Vestibular Fistulae

Intervention / Treatment
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* Procedure: TSARP
* Procedure: PSARP
* Procedure: Classic ASARP
* Procedure: Modified ASARP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TSARP<br>Is a surgical procedure | Procedure: TSARP<br>* We make four different surgical operations for female patients with rectovestibular fistula<br>* Other names: Transfistula anorectoplasty TFARP;|
| ASARP classic<br>Surgical procedure | Procedure: Classic ASARP<br>* Anterior Sagittal anorectoplasty<br>* Other names: Anterior Sagittal anorectoplasty;|
| PSARP<br>Surgical procedure | Procedure: PSARP<br>* Posterior sagittal anorectoplasty<br>* Other names: Posterior sagittal anorectoplasty;|
| Modified ASARP<br>Surgical procedure | Procedure: Modified ASARP<br>* External anal sphincter preservation<br>* Other names: External anal sphincter preservation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Templeton score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular anus,, Anal transposition,, Anorectal malformations, Transfistula anorectoplasty