Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
NCT ID: NCT00830661
Last Updated: 2009-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
124 participants
INTERVENTIONAL
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LIFT
those subjects receiving the Ligation of Intersphincteric Fistula Track procedure
Ligation of intersphincteric fistula track procedure
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.
Plug
those subjects randomized to the receive the placement of the porcine anal fistula plug
anal fistula plug
placement of the porcine anal fistula plug as per the instructions for use in product packaging
Interventions
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Ligation of intersphincteric fistula track procedure
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.
anal fistula plug
placement of the porcine anal fistula plug as per the instructions for use in product packaging
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
University of Ottawa
OTHER
Massachusetts General Hospital
OTHER
Colon and Rectal Surgery Associates, Ltd.
OTHER
Responsible Party
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University of Minnesota/Colon and Rectal Surgery Associates. Ltd
Principal Investigators
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Heather L Rossi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota/Colon and Rectal Surgery Associates, Ltd.
Husein Moloo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Joshua Bleier, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Health System
Liliana Bordeianou, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Colon and Rectal Surgery Associates, Ltd
Minneapolis, Minnesota, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Ottawa
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Liliana Bordeianou, MD
Role: primary
Deb Jones, BS
Role: primary
Rachael Peterson, BS
Role: backup
Joshua Bleier, MD
Role: primary
Husein Moloo, MD
Role: primary
Jonathon Cook, PhD
Role: backup
Other Identifiers
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SMG1108
Identifier Type: -
Identifier Source: org_study_id