Treatment of Perianal FIstulas in Crohn*s Disease: Surgical closure vs Anti-TNF
- Conditions
- Perianal fistula10002112
- Registration Number
- NL-OMON48901
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
- >= 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;- Use of Anti-TNF medication for more than 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 with a contra-indication for anti-TNF ;- 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 of patients with closed fistulas<br /><br>(based on an evaluated MRI-score) after 18 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are disease activity by Perianal Disease Activity Index<br /><br>(PDAI), quality of life and costs.</p><br>