A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

September 7, 2021 updated by: Rush University Medical Center
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.

The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.

This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is 22 years of age or older
  2. Subject is willing to comply with study related procedures
  3. Subject is not pregnant
  4. Subject has a transsphincteric fistula
  5. Subject is medically fit to undergo LIFT
  6. Subject has a draining seton for a minimum of 6 weeks

Exclusion Criteria:

  1. Crohn's disease
  2. Pelvic radiation treatment
  3. Known or suspected HIV/AIDS
  4. Known sensitivity to pork products
  5. Abscess or fistula etiology other than cryptoglandular
  6. Abdominal malignancies
  7. Patients with <1 year life expectancy
  8. History of smoking
  9. Known anorectal dysfunction (fecal incontinence)
  10. Chronic use of steroids or other agents which may affect wound healing
  11. ASA ≥ 2
  12. Unable to consent to study
  13. Unable to complete 1 year follow up

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strattice-LIFT
Device: Strattice-LIFT
Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of the anal fistula
Time Frame: 6 months
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of the anal fistula
Time Frame: 1 year
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
1 year
Postoperative Pain
Time Frame: 1 year
Postoperative pain will be assessed at each postoperative visit with a visual analog scale
1 year
Complications
Time Frame: 1 year
Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence
1 year

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

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 (Actual)

September 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14072904

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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