Status:
UNKNOWN
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
Lead Sponsor:
Colon and Rectal Surgery Associates, Ltd.
Collaborating Sponsors:
University of Pennsylvania
University of Ottawa
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years of age or older.
- Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
Exclusion
- History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
- History of connective tissue disease.
- Rectovaginal fistula.
- Presence of horseshoe fistula.
- History of immunosuppression therapy/treatment within previous six months.
- Presents of a proximal diversion and refractory fistula.
- Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.
- Known history of allergy to pork or pork products.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00830661
Start Date
March 1 2009
Last Update
May 29 2009
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Colon and Rectal Surgery Associates, Ltd
Minneapolis, Minnesota, United States, 55455
3
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
4
University of Ottawa
Ottawa, Ontario, Canada, K1N6N5