Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

Not Applicable

Completed

• Conditions: Anal Cancer

• Registration Number: NCT03983174
• Lead Sponsor: Mansoura University

Brief Summary

Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-15
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients suffering from high trans-sphincteric anal fistula

Exclusion Criteria

• Acute sepsis.
• Specific cause of fistula e.g. Crohn's disease
• Strictured anorectum.
• Any degree of incontinence
• Recurrent anal fistula.
• Low anal fistula.
• Previous anorectal surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fecal incontinence	12 months after surgery	Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt