Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Not Applicable
Terminated
- Conditions
- Crohn's Disease
- Registration Number
- NCT00252369
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.
- Detailed Description
Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Perianal fistula of Crohn's dis
Exclusion Criteria
- More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Fistula healing
- Secondary Outcome Measures
Name Time Method Quality of life Complications
Trial Locations
- Locations (4)
Meir Medical Center
🇮🇱Kfar Saba, Israel
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Assaf Harofe Medical Center
🇮🇱Zrifin, Israel