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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: April 30, 2018
- 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
- 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
- Patients suffering from high trans-sphincteric anal fistula
- 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
- 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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.