Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

Sheba Medical Center

Status: Terminated

Conditions: Crohn's Disease

Treatments: Procedure: Instillation of fibrin glue; Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00252369

SHEBA-05-3762-OZ-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Perianal fistula of Crohn's dis

Exclusion criteria

• More then 2 fistulae perianal sepsis known contraindication to infliximab or glue

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)