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

Primary Purpose

Anal Fistula, Rectal Fistula, Fistula in Ano

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Strattice-LIFT
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

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

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Strattice-LIFT

Arm Description

Outcomes

Primary Outcome Measures

Healing of the anal fistula
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2015
Last Updated
September 7, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02423330
Brief Title
A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
Official Title
A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Study terminated by sponsor
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula, Rectal Fistula, Fistula in Ano, Transsphincteric Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strattice-LIFT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Strattice-LIFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing of the anal fistula
Description
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Healing of the anal fistula
Description
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
Time Frame
1 year
Title
Postoperative Pain
Description
Postoperative pain will be assessed at each postoperative visit with a visual analog scale
Time Frame
1 year
Title
Complications
Description
Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 22 years of age or older Subject is willing to comply with study related procedures Subject is not pregnant Subject has a transsphincteric fistula Subject is medically fit to undergo LIFT Subject has a draining seton for a minimum of 6 weeks Exclusion Criteria: Crohn's disease Pelvic radiation treatment Known or suspected HIV/AIDS Known sensitivity to pork products Abscess or fistula etiology other than cryptoglandular Abdominal malignancies Patients with <1 year life expectancy History of smoking Known anorectal dysfunction (fecal incontinence) Chronic use of steroids or other agents which may affect wound healing ASA ≥ 2 Unable to consent to study Unable to complete 1 year follow up
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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