Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair

Anal Fistula Clinical Trial

— LIFT vs PLUG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00830661
• Other study ID #: SMG1108
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2009
• Last updated: May 28, 2009
• Start date: March 2009

Study information

• Verified date: May 2009
• Source: Colon and Rectal Surgery Associates, Ltd.
• Contact: Deb J Jones, BS
• Phone: 651-225-7830
• Email: djones[@]crsal.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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.
• anal fistula plug
placement of the porcine anal fistula plug as per the instructions for use in product packaging

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Colon and Rectal Surgery Associates, Ltd	Minneapolis	Minnesota
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Colon and Rectal Surgery Associates, Ltd.	Massachusetts General Hospital, University of Ottawa, University of Pennsylvania

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1month, 3 month, 6 month, 12 month postoperatively	No
Secondary	Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation		1 month, 3 month, 6 month, 12 months postoperatively	No