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

This study has been terminated.
(Low accrual rate)
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00252369
First received: November 10, 2005
Last updated: April 23, 2009
Last verified: April 2009
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252369

Locations
Israel
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
Investigators
Principal Investigator: Oded Zmora, MD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov 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
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Fibrin Tissue Adhesive
Infliximab
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014