Factibility And Security Study Of The Pics-Af(Tm) Plug For The Treatment Of Cryptoglandular Anal Fistula

Introduction: The PICS-AF (TM) (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fistulas.Methods: A total of 44 patients (34 men), with a mean age of 54.68 +/- 7.3, with trans-sphincteric anal fistulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed.Results: Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4 recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5 were mild, 5 moderate and 2 severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients).Conclusions: The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate. (C) 2017 AEC. Published by Elsevier Espana, S.L.U. All rights reserved.