Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.|
- Fistula healing
- Quality of life
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252369
|Meir Medical Center|
|Kfar Saba, Israel|
|Tel Aviv Medical Center|
|Tel Aviv, Israel|
|Sheba Medical Center|
|Tel Hashomer, Israel|
|Assaf Harofe Medical Center|
|Principal Investigator:||Oded Zmora, MD||Sheba Medical Center|