Back to resultsTreatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Infliximab
Instillation of fibrin glue
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria: Perianal fistula of Crohn's dis Exclusion Criteria: More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
Sites / Locations
- Meir Medical Center
- Tel Aviv Medical Center
- Sheba Medical Center
- Assaf Harofe Medical Center
Outcomes
Primary Outcome Measures
Fistula healing
Secondary Outcome Measures
Quality of life
Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252369
Brief Title
Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Official Title
Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Low accrual rate
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Type
Procedure
Intervention Name(s)
Instillation of fibrin glue
Primary Outcome Measure Information:
Title
Fistula healing
Secondary Outcome Measure Information:
Title
Quality of life
Title
Complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Perianal fistula of Crohn's dis
Exclusion Criteria:
More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oded Zmora, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Assaf Harofe Medical Center
City
Zrifin
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
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