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

This study has been terminated.
(Low accrual rate)
Information provided by:
Sheba Medical Center Identifier:
First received: November 10, 2005
Last updated: April 23, 2009
Last verified: April 2009
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.

Condition Intervention
Crohn's Disease
Drug: Infliximab
Procedure: Instillation of fibrin glue

Study Type: Interventional
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.

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Fistula healing

Secondary Outcome Measures:
  • Quality of life
  • Complications

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.

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Perianal fistula of Crohn's dis

Exclusion Criteria:

  • More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
  Contacts and Locations
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Please refer to this study by its 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
Zrifin, Israel
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Oded Zmora, MD Sheba Medical Center
  More Information Identifier: NCT00252369     History of Changes
Other Study ID Numbers: SHEBA-05-3762-OZ-CTIL 
Study First Received: November 10, 2005
Last Updated: April 23, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Fibrin Tissue Adhesive
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Hematologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on April 27, 2016