A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
NCT ID: NCT02423330
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
1 participants
INTERVENTIONAL
2014-09-30
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Strattice-LIFT
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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14072904
Identifier Type: -
Identifier Source: org_study_id
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