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

Colon and Rectal Surgery Associates, Ltd.

Status: Unknown

Conditions: Anal Fistula

Treatments: Procedure: anal fistula plug; Procedure: Ligation of intersphincteric fistula track procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00830661

SMG1108

Details and patient eligibility

About

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

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

LIFT

Active Comparator group

Description:

those subjects receiving the Ligation of Intersphincteric Fistula Track procedure

Treatment:

Procedure: Ligation of intersphincteric fistula track procedure

Plug

Active Comparator group

Description:

those subjects randomized to the receive the placement of the porcine anal fistula plug

Treatment:

Procedure: anal fistula plug