The role of the Anal Fistula Plug combined with infliximab in the treatment of perianal fistula due to Crohn*s disease. -a randomised controlled trial
- Conditions
- anorectal fistulaperianal fistula1000211210017998
- Registration Number
- NL-OMON29741
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Crohn*s disease
Infliximab treatment and chronic loose seton drainage > 2 months
High anorectal fistula (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal)
Informed consent
Exclusion Criteria
Cryptoglandular fistula
Age<18 years
HIV-positive
No internal opening found during surgery
Perianal abscesses on preoperative MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Anorectal fistula closure rate<br /><br><br /><br>2. Continence</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Morbidity<br /><br><br /><br>2. Quality of life</p><br>