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

NCT00830661 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2009-05-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • University of Ottawa

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Colon and Rectal Surgery Associates, Ltd.

    lead OTHER

Principal Investigators

  • Heather L Rossi, MD · University of Minnesota/Colon and Rectal Surgery Associates, Ltd.

  • Husein Moloo, MD · University of Ottawa

  • Joshua Bleier, MD · University of Pennsylvania Health System

  • Liliana Bordeianou, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-03-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830661 on ClinicalTrials.gov