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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Colon and Rectal Surgery Associates, Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Pennsylvania
University of Ottawa
Massachusetts General Hospital
Information provided by:
Colon and Rectal Surgery Associates, Ltd.
ClinicalTrials.gov Identifier:
NCT00830661
First received: January 27, 2009
Last updated: May 28, 2009
Last verified: May 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Active Comparator: LIFT
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.
Active Comparator: Plug
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
University of Ottawa
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: Dr. Stanley M. Goldberg, MD Study Director, University of Minnesota/Colon and Rectal Surgery Associates. Ltd
ClinicalTrials.gov Identifier: NCT00830661     History of Changes
Other Study ID Numbers: SMG1108
Study First Received: January 27, 2009
Last Updated: May 28, 2009
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

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 27, 2014