wetenschapsdag 2023 | 69 Sessie 2c: Laat Me, opereren! 1 Auteurs E.M. Meima- van Praag*, A.J.M. Pronk*, V. Bellato, T. Banasiewicz, S. Madelska, C.J.Buskens on behalf of the Semiflex Research Group Abstract titel Semiflex assisted vacuum therapy for perianal abscesses/ sinuses and fistula: study protocol for a pilot study Background Perianal fistulas and abscesses are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses and fistulas: the Semiflex Dome Catheter System. With this study, we aim to test the feasibility and efficacy of the novel catheter set for vacuum therapy of perianal abscesses and fistulas. Methods This is a prospective, multicentre, pilot study. Patients > eighteen years with perianal abscess(es), perianal/pararectal sinus, or perianal fistula are eligible for inclusion. A Semiflex catheter is inserted under general anaesthesia in patients with a perianal fistula after closure of the internal opening or in patients with a perianal abscess/sinus. The Semiflex catheter is fixed using a Renasys Adhesive gel patch and is connected to a vacuum pomp with a vacuum pressure of 80 or 125 cm H2O. Every other day, the Semiflex catheter will be exchanged for a smaller and shorter Semiflex catheter in the outpatient setting. The therapy is continued for a maximum of four weeks until the fistula tract or abscess/sinus is practically closed. The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing of the Semiflex catheters, capability of proper fixation of the Semiflex catheter, maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Conclusion The Semiflex pilot study is a prospective, multicentre, feasibility study of patients with perianal abscesses/sinuses or perianal fistula. Once this study shows positive results on the feasibility and efficacy of the Semiflex Dome Catheter System, management of perianal fistulas and abscesses could change.
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