Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair (LIFT vs PLUG)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Colon and Rectal Surgery Associates, Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Colon and Rectal Surgery Associates, Ltd.
Collaborators:
University of Pennsylvania
University of Ottawa
Massachusetts General Hospital
Information provided by:
Colon and Rectal Surgery Associates, Ltd.
ClinicalTrials.gov Identifier:
NCT00830661
First received: January 27, 2009
Last updated: May 28, 2009
Last verified: May 2009
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Purpose
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 fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug
| Condition | Intervention |
|---|---|
|
Anal Fistula |
Procedure: Ligation of intersphincteric fistula track procedure Procedure: anal fistula plug |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin |
Resource links provided by NLM:
Further study details as provided by Colon and Rectal Surgery Associates, Ltd.:
Primary Outcome Measures:
- The primary outcome measure of this study will be to compare the rate of fistula closure between the ligation of the intersphincteric fistula track (LIFT) procedure and the use of a porcine bioabsorbable anal fistula plug [ Time Frame: 1month, 3 month, 6 month, 12 month postoperatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation [ Time Frame: 1 month, 3 month, 6 month, 12 months postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LIFT
those subjects receiving the Ligation of Intersphincteric Fistula Track procedure
|
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.
|
|
Active Comparator: Plug
those subjects randomized to the receive the placement of the porcine anal fistula plug
|
Procedure: anal fistula plug
placement of the porcine anal fistula plug as per the instructions for use in product packaging
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830661
Contacts
| Contact: Deb J Jones, BS | 651-225-7830 | djones@crsal.org |
| Contact: Rachael Peterson, BS | 651-225-7817 | rpeterson@crsal.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Liliana Bordeianou, MD 617-643-0541 | |
| Principal Investigator: Liliana Bordeianou, MD | |
| United States, Minnesota | |
| Colon and Rectal Surgery Associates, Ltd | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Deb Jones, BS 651-225-7830 djones@crsal.org | |
| Contact: Rachael Peterson, BS 651-225-7817 rpeterson@crsal.org | |
| Principal Investigator: Heather Rossi, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joshua Bleier, MD Joshua.Bleier@uphs.upenn.edu | |
| Principal Investigator: Joshua Bleier, MD | |
| Canada, Ontario | |
| University of Ottawa | Not yet recruiting |
| Ottawa, Ontario, Canada, K1N6N5 | |
| Contact: Husein Moloo, MD hmoloo@ottawahospital.on.ca | |
| Contact: Jonathon Cook, PhD jcook@ohri.ca | |
| Principal Investigator: Husein Moloo, MD | |
| Sub-Investigator: Jonathon Cook, PhD | |
Sponsors and Collaborators
Colon and Rectal Surgery Associates, Ltd.
University of Pennsylvania
University of Ottawa
Massachusetts General Hospital
Investigators
| Principal Investigator: | Heather L Rossi, MD | University of Minnesota/Colon and Rectal Surgery Associates, Ltd. |
| Principal Investigator: | Husein Moloo, MD | University of Ottawa |
| Principal Investigator: | Joshua Bleier, MD | University of Pennsylvania Health System |
| Principal Investigator: | Liliana Bordeianou, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Stanley M. Goldberg, MD Study Director, University of Minnesota/Colon and Rectal Surgery Associates. Ltd |
| ClinicalTrials.gov Identifier: | NCT00830661 History of Changes |
| Other Study ID Numbers: | SMG1108 |
| Study First Received: | January 27, 2009 |
| Last Updated: | May 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Colon and Rectal Surgery Associates, Ltd.:
|
transsphincteric anal fistula cryptoglandular origin anal fistula repair |
Ligation of Intersphincteric Fistula Track (LIFT) procedure anal fistula plug (Plug) surgical repair |
Additional relevant MeSH terms:
|
Fistula Rectal Fistula Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on October 18, 2012
