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This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
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.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Rush University Medical Center
Chicago, Illinois, United States
Start Date
September 1, 2014
Primary Completion Date
August 1, 2017
Completion Date
August 1, 2017
Last Updated
September 14, 2021
1
ACTUAL participants
Strattice-LIFT
DEVICE
Lead Sponsor
Rush University Medical Center
NCT06918808
NCT05039411
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06803550