Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| Contact: | Deb J Jones, BS |
| Email: | djones@crsal.org |
| Phone: | 651-225-7830 |
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
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
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
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.
We found this trial at
3
sites
3400 Spruce Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-662-4000
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