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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830661

Acronym

LIFT vs PLUG

Enrollment

124

Registered

2009-01-28

Start date

2009-03-31

Completion date

Unknown

Last updated

2009-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

PROCEDURELigation 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.

PROCEDUREanal fistula plug

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

Canada, United States

Contacts

Primary ContactDeb J Jones, BS

djones@crsal.org651-225-7830

Backup ContactRachael Peterson, BS

rpeterson@crsal.org651-225-7817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026