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

May 28, 2009 updated by: Colon and Rectal Surgery Associates, Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N6N5
        • Not yet recruiting
        • University of Ottawa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Husein Moloo, MD
        • Sub-Investigator:
          • Jonathon Cook, PhD
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
          • Liliana Bordeianou, MD
          • Phone Number: 617-643-0541
        • Principal Investigator:
          • Liliana Bordeianou, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Colon and Rectal Surgery Associates, Ltd
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heather Rossi, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Health System
        • Principal Investigator:
          • Joshua Bleier, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1month, 3 month, 6 month, 12 month postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
1 month, 3 month, 6 month, 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colon and Rectal Surgery Associates, Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
University of Pennsylvania
University of Ottawa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liliana Bordeianou, MD, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMG1108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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