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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
History of Changes

January 27, 2009
May 28, 2009
March 2009
March 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830661 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anal Fistula
  • 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.
  • Procedure: anal fistula plug
    placement of the porcine anal fistula plug as per the instructions for use in product packaging
  • Active Comparator: LIFT
    those subjects receiving the Ligation of Intersphincteric Fistula Track procedure
    Intervention: Procedure: Ligation of intersphincteric fistula track procedure
  • Active Comparator: Plug
    those subjects randomized to the receive the placement of the porcine anal fistula plug
    Intervention: Procedure: anal fistula plug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
Not Provided
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Deb J Jones, BS 651-225-7830 djones@crsal.org
Contact: Rachael Peterson, BS 651-225-7817 rpeterson@crsal.org
United States,   Canada
 
NCT00830661
SMG1108
Yes
Dr. Stanley M. Goldberg, MD Study Director, University of Minnesota/Colon and Rectal Surgery Associates. Ltd
Colon and Rectal Surgery Associates, Ltd.
  • University of Pennsylvania
  • University of Ottawa
  • Massachusetts General Hospital
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
Colon and Rectal Surgery Associates, Ltd.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP