Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula
Overview
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
Full Title of Study: “Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: April 30, 2018
Interventions
- Procedure: Drainage seton with flap
- Seton is placed around the external sphincter then mucosal advancement flap will be constructed
- Procedure: EAS sparing seton
- Rerouting of the seton around the internal sphincter only sparing the external sphincter
Arms, Groups and Cohorts
- Experimental: Drainage seton with flap
- Drainage seton will be put around the external anal sphincter with mucosal advancement flap
- Experimental: EAS sparing seton
- Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done
Clinical Trial Outcome Measures
Primary Measures
- fecal incontinence
- Time Frame: 12 months after surgery
- Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Mansoura University
- Provider of Information About this Clinical Study
- Principal Investigator: Sameh Emile, Principal investigator – Mansoura University
- Overall Official(s)
- Sameh Emile, M.D., Principal Investigator, Mansoura University
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