Recruiting

LIFT vs. Fistula Plug

Sponsor:

Colon and Rectal Surgery Associates, Ltd.

Code:

NCT00830661

Conditions

Anal Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ligation of intersphincteric fistula track procedure

anal fistula plug

Study Details

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

Conditions

Anal Fistula

Study ID

NCT00830661

Start date

Mar, 2009

Status verified date

May, 2009

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: LIFT

those subjects receiving the Ligation of Intersphincteric Fistula Track procedure

active comparator: Plug

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

Interventions

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

Primary outcome 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 [ Time Frame: 1month, 3 month, 6 month, 12 month postoperatively ]

Central Contacts and Locations

Central contacts

Deb J Jones, BS

651-225-7830djones@crsal.org

Rachael Peterson, BS

651-225-7817rpeterson@crsal.org

Locations

Colon and Rectal Surgery Associates, Ltd

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Deb Jones, BS

651-225-7830djones@crsal.org

Rachael Peterson, BS

651-225-7817rpeterson@crsal.org

Principal Investigator:

Heather Rossi, MD

University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Joshua Bleier, MD

Joshua.Bleier@uphs.upenn.edu

Principal Investigator:

Joshua Bleier, MD

More Information

Sponsor

Colon and Rectal Surgery Associates, Ltd.

Last update posted

May 29, 2009

Last verified

May, 2009

Keywords

  • transsphincteric anal fistula
  • cryptoglandular origin
  • anal fistula repair
  • Ligation of Intersphincteric Fistula Track (LIFT) procedure
  • anal fistula plug (Plug)
  • surgical repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Colon and Rectal Surgery Associates, Ltd. on 2009-05-29.