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
About this trial
This is an interventional treatment trial for Anal Fistula
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
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
NCT ID
NCT02423330
First Posted
April 17, 2015
Last Updated
September 7, 2021
Sponsor
Rush University Medical Center
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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