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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)

Primary Purpose

Anal Fistula

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Ligation of intersphincteric fistula track procedure

anal fistula plug

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring transsphincteric anal fistula, cryptoglandular origin, anal fistula repair, Ligation of Intersphincteric Fistula Track (LIFT) procedure, anal fistula plug (Plug), surgical repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital
Colon and Rectal Surgery Associates, LtdRecruiting
University of Pennsylvania Health SystemRecruiting
University of Ottawa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LIFT

Plug

Arm Description

those subjects receiving the Ligation of Intersphincteric Fistula Track procedure

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

Outcomes

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

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

Full Information

NCT ID

NCT00830661

First Posted

January 27, 2009

Last Updated

May 28, 2009

Sponsor

Colon and Rectal Surgery Associates, Ltd.

Collaborators

University of Pennsylvania, University of Ottawa, Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00830661

Brief Title

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

Acronym

LIFT vs PLUG

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Colon and Rectal Surgery Associates, Ltd.

Collaborators

University of Pennsylvania, University of Ottawa, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fistula

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LIFT

Arm Type

Active Comparator

Arm Description

those subjects receiving the Ligation of Intersphincteric Fistula Track procedure

Arm Title

Plug

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ligation of intersphincteric fistula track procedure

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

anal fistula plug

Intervention Description

placement of the porcine anal fistula plug as per the instructions for use in product packaging

Primary Outcome Measure Information:

Title

Time Frame

1month, 3 month, 6 month, 12 month postoperatively

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Deb J Jones, BS

Phone

651-225-7830

djones@crsal.org

First Name & Middle Initial & Last Name or Official Title & Degree

Rachael Peterson, BS

Phone

651-225-7817

rpeterson@crsal.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather L Rossi, MD

Organizational Affiliation

University of Minnesota/Colon and Rectal Surgery Associates, Ltd.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Husein Moloo, MD

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joshua Bleier, MD

Organizational Affiliation

University of Pennsylvania Health System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liliana Bordeianou, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liliana Bordeianou, MD

Phone

617-643-0541

First Name & Middle Initial & Last Name & Degree

Liliana Bordeianou, MD

Facility Name

Colon and Rectal Surgery Associates, Ltd

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deb Jones, BS

Phone

651-225-7830

djones@crsal.org

First Name & Middle Initial & Last Name & Degree

Rachael Peterson, BS

Phone

651-225-7817

rpeterson@crsal.org

First Name & Middle Initial & Last Name & Degree

Heather Rossi, MD

Facility Name

University of Pennsylvania Health System

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joshua Bleier, MD

Joshua.Bleier@uphs.upenn.edu

First Name & Middle Initial & Last Name & Degree

Joshua Bleier, MD

Facility Name

University of Ottawa

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N6N5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Husein Moloo, MD

hmoloo@ottawahospital.on.ca

First Name & Middle Initial & Last Name & Degree

Jonathon Cook, PhD

jcook@ohri.ca

First Name & Middle Initial & Last Name & Degree

Husein Moloo, MD

First Name & Middle Initial & Last Name & Degree

Jonathon Cook, PhD

12. IPD Sharing Statement

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

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