Multimodal treatment of perianal fistulas in Crohn's Disesase: seton versus anti-TNF versus advancement plasty
Recruiting
- Conditions
- perianal fistulas, Crohn's diseaseperianale fistels, ziekte van Crohn
- Registration Number
- NL-OMON22680
- Lead Sponsor
- Academic Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 126
Inclusion Criteria
≥ 18 years
- Written informed consent
Exclusion Criteria
- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum)
- Anorectal stenosis (defined as the impossibility to introduce a proctoscope)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to analyse the number of patients that need a re-intervention due to fistula-related complications (abscesses, recurrent or new tract formation).
- Secondary Outcome Measures
Name Time Method The secondary outcomes parameters will be the number of patients with closed fistulas (based on MRI findings) after 18 months, Perianal Disease Activity Index (PDAI score) and number of necessary antibiotics courses during fistula treatment, quality of life (EQ-5D and IBDQ), and costs (KEA and BIA).