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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02423330
Study type Interventional
Source Rush University Medical Center
Contact
Status Terminated
Phase Early Phase 1
Start date September 2014
Completion date August 2017

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