Prospective pilot study of anorectal ﬁstula closure with the OTSC Proctology
The OTSC Proctology is a surgical device for anorectal ﬁstula closure. It consists of a super-elastic nitinol clip, which is placed (with the aid of a transanal applicator) on the internal ﬁstula opening to achieve healing of the ﬁstula track. A prospective, two-centre clinical pilot study was undertaken to assess the efﬁcacy and safety of the OTSC Proctology in patients with a complex high anorectal ﬁstula.
Method In patients with a complex anorectal ﬁstula the primary track was debrided using a special brush and the clip was applied to the internal ﬁstula opening. After 6 months the postoperative clinical course and ﬁstula healing were assessed.
Twenty patients with a cryptoglandular anorectal ﬁstula (14 with a transsphincteric ﬁstula and six with a suprasphincteric ﬁstula) were included in the study. There were no intra-operative technical or surgical complications. Postoperatively no patient reported intolerable discomfort or a sensation of a foreign body in the anal region. At 6 months after surgery, 18 (90%) patients had no clinical signs or symptoms of ﬁstula and were considered healed, whereas in two the ﬁstula persisted. In 13 (72%) of these 18 patients, the clip was still in place without causing problems, whereas in three patients the clip had spontaneously detached. In the two remaining patients it was necessary to remove the clip due to discomfort and delayed wound healing.
Anorectal ﬁstula closure with the OTSC Proctology is an innovative, sphincter-preserving minimally invasive procedure with promising initial results and a high rate of patient satisfaction.
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