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

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

This study is currently recruiting participants.

Verified by Colon and Rectal Surgery Associates, Ltd., April 2009

First Received: January 27, 2009 Last Updated: April 22, 2009 History of Changes

Sponsors and Collaborators:	Colon and Rectal Surgery Associates, Ltd. University of Pennsylvania Health Care System University of Ottawa Hospital Massachusetts General Hospital
Information provided by:	Colon and Rectal Surgery Associates, Ltd.
ClinicalTrials.gov Identifier:	NCT00830661

Purpose

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

Condition	Intervention
Anal Fistula	Procedure: Ligation of intersphincteric fistula track procedure Procedure: anal fistula plug

MedlinePlus related topics: Fistulas Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Colon and Rectal Surgery Associates, Ltd.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation [ Time Frame: 1 month, 3 month, 6 month, 12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LIFT: Active Comparator those subjects receiving the Ligation of Intersphincteric Fistula Track procedure	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.
Plug: Active Comparator those subjects randomized to the receive the placement of the porcine anal fistula plug	Procedure: anal fistula plug placement of the porcine anal fistula plug as per the instructions for use in product packaging

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830661

Contacts

Contact: Deb J Jones, BS	651-225-7830	djones@crsal.org
Contact: Rachael Peterson, BS	651-225-7817	rpeterson@crsal.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Liliana Bordeianou, MD 617-643-0541
Principal Investigator: Liliana Bordeianou, MD
United States, Minnesota
Colon and Rectal Surgery Associates, Ltd	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Deb Jones, BS 651-225-7830 djones@crsal.org
Contact: Rachael Peterson, BS 651-225-7817 rpeterson@crsal.org
Principal Investigator: Heather Rossi, MD
United States, Pennsylvania
University of Pennsylvania Health System	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joshua Bleier, MD Joshua.Bleier@uphs.upenn.edu
Principal Investigator: Joshua Bleier, MD
Canada, Ontario
University of Ottawa	Not yet recruiting
Ottawa, Ontario, Canada, K1N6N5
Contact: Husein Moloo, MD hmoloo@ottawahospital.on.ca
Contact: Jonathon Cook, PhD jcook@ohri.ca
Principal Investigator: Husein Moloo, MD
Sub-Investigator: Jonathon Cook, PhD

Sponsors and Collaborators

Colon and Rectal Surgery Associates, Ltd.

University of Pennsylvania Health Care System

University of Ottawa Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:	Heather L Rossi, MD	University of Minnesota/Colon and Rectal Surgery Associates, Ltd.
Principal Investigator:	Husein Moloo, MD	University of Ottawa
Principal Investigator:	Joshua Bleier, MD	University of Pennsylvania Health System
Principal Investigator:	Liliana Bordeianou, MD	Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	University of Minnesota/Colon and Rectal Surgery Associates. Ltd ( Dr. Stanley M. Goldberg, MD Study Director )
Study ID Numbers:	SMG1108
Study First Received:	January 27, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00830661 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Colon and Rectal Surgery Associates, Ltd.:

transsphincteric anal fistula
cryptoglandular origin
anal fistula repair

Ligation of Intersphincteric Fistula Track (LIFT) procedure
anal fistula plug (Plug)
surgical repair

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases

Intestinal Fistula
Intestinal Diseases
Rectal Diseases
Fistula

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Fistula

Digestive System Fistula
Intestinal Diseases
Rectal Diseases
Fistula

ClinicalTrials.gov processed this record on May 06, 2009