The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas.
Completed
- Conditions
- Perianal fistula
- Registration Number
- NL-OMON22310
- Lead Sponsor
- Academic Medical Centremeibergdreef 91105 AZ Amsterdam+31-205669111
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. High anorectal fistula of cryptoglandular origin (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal);
2. Informed consent.
Exclusion Criteria
1. Age<18 years;
2. HIV-positive;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Anorectal fistula closure rate;<br /><br>2. Continence.<br>
- Secondary Outcome Measures
Name Time Method 1. Morbidity;<br /><br>2. Post-operative pain;<br /><br>3. Sick leave;<br /><br>4. Quality of life.<br>