Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty
- Conditions
- perianal fistula10002112
- Registration Number
- NL-OMON45001
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
- * 18 years;- Written informed consent;- High tract (intersphincteric, transsphincteric, suprasphincteric) perianal fistula located in the upper ;two-thirds of the external sphincter ;- Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not ;have to be taken into account;- Both new fistulas or recurrent active fistula (defined as any producing fistula)
- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum);- Anorectal stenosis (defined as the impossibility to introduce a proctoscope);- Submucosal fistulas & low intersphincteric fistulas (lower one-third of external sphincter);- Rectovaginal fistula;- Multiple internal openings;- Seton in situ for more than 3 months;- Use of Anti-TNF medication during last 3 months;- Previous Anti-TNF medication without any effect on perianal fistulas;- Previously demonstrated allergy for anti-TNF medication. If this allergy only concerns the chimeric ;monoclonal mouse-antibody infliximab, the patient could be randomised for adalumimab;- Patients with a stoma;- Immunocompromised patients (i.e. haematological malignancies, HIV/AIDS, bone marrow ;transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, ;chemotherapy, dialysis, solid organ transplant and long term immunosuppressant use such as ;corticosteroids in patients with rheumatoid arthritis);- Life expectancy < 2 years;- The inability of reading/understanding and filling in the questionnaires;- Dementia or altered mental status that would prohibit the understanding and giving of informed ;consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter is the number patients needing fistula-related<br /><br>re-intervention(s).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are the number of patients with closed fistulas and the<br /><br>percentage of closed fistulas (based on MRI) after 18 months, and the number of<br /><br>antibiotic courses that was required during treatment. Furthermore we evaluate<br /><br>the Perianal Disease Activity Index, quality of life, and costs.</p><br>