Clinical trial NCT00830661: Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Keywords: transsphincteric anal fistula
cryptoglandular origin
anal fistula repair
Ligation of Intersphincteric Fistula Track (LIFT) procedure
anal fistula plug (Plug)
surgical repair
Lead sponsor: Colon and Rectal Surgery Associates, Ltd.
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Ottawa
name: Massachusetts General Hospital
First posted: 2009-01-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 1month, 3 month, 6 month, 12 month postoperatively
Secondary outcomes:
measure: Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation
timeFrame: 1 month, 3 month, 6 month, 12 months postoperatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Colon and Rectal Surgery Associates, Ltd
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Minnesota/Colon and Rectal Surgery Associates, Ltd.
name: Heather L Rossi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Husein Moloo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania Health System
name: Joshua Bleier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Liliana Bordeianou, MD
role: PRINCIPAL_INVESTIGATOR
References: