NCT00830661

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

3 years

First QC Date

January 27, 2009

Last Update Submit

May 28, 2009

Conditions

Anal Fistula

Keywords

transsphincteric anal fistulacryptoglandular originanal fistula repairLigation of Intersphincteric Fistula Track (LIFT) procedureanal fistula plug (Plug)surgical repair

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (1)

  • Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation

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

Study Arms (2)

LIFT

ACTIVE COMPARATOR

those subjects receiving the Ligation of Intersphincteric Fistula Track procedure

Procedure: Ligation of intersphincteric fistula track procedure

Plug

ACTIVE COMPARATOR

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

Procedure: anal fistula plug

Interventions

Ligation of intersphincteric fistula track procedurePROCEDURE

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.

LIFT
anal fistula plugPROCEDURE

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

Plug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Colon and Rectal Surgery Associates, Ltd

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deb J Jones, BS

CONTACT

651-225-7830djones@crsal.org

Rachael Peterson, BS

CONTACT

651-225-7817rpeterson@crsal.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2012

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations

US(3)CA(1)