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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00252369
Recruitment Status : Terminated (Low accrual rate)
First Posted : November 11, 2005
Last Update Posted : April 24, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Crohn's Disease Drug: Infliximab Procedure: Instillation of fibrin glue

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Primary Outcome Measures :
  1. Fistula healing

Secondary Outcome Measures :
  1. Quality of life
  2. Complications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00252369     History of Changes
Other Study ID Numbers: SHEBA-05-3762-OZ-CTIL
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: April 24, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Fibrin Tissue Adhesive
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents