This October, a Scientific Report about the clinical validation of the SuperSeton was published in a journal of the Nature Publishing Group. The study validates the feasibility of SuperSeton's knotless seton, and demonstrates how it is preferred over conventional setons. We are proud to have reached this important milestone and thank those that have been involved in the trials.
Please read the summary of the report below or download a pdf of the original publication here.
M. E. Stellingwerf (1), M. T. J. Bak (2), C. B. H. Molenaar (2), J. de Groof (1), C. J. Buskens (1), W. Nerkens (3), T. Horeman (3,4), W. A. Bemelman (1)
1: Academic Medical Center, Amsterdam (NL), 2: Proctos Kliniek, Bilthoven (NL), 3: MediShield B.V., Delft (NL), 4: Delft University of Technology, Delft (NL)
Perianal fistulas are a common incapacitating problem. Many patients are treated by seton drainage to prevent recurrent abscess formation. For centuries, vessel loops or sutures have been used for seton drainage and the knot is well-known for causing complaints. The aim of this study was to determine the feasibility and the advantages of the knotless SuperSeton.
In this prospective cohort study, we included all patients ≥18 years with drained or undrained perianal fistulas and no defunctioning stoma. Primary outcome was seton failure (loosening of the connection). Secondary outcomes were quality of life measured by the PDAI (‘Perianal Disease Activity Index’) and complications.
Sixty patients (42% male, mean age 42 (SD 13.16)) were included between August 2016 and March 2018. In total 79 SuperSetons were placed (50 knotted seton replacements). Of these 79 knotless setons, 69 (87.3%) stayed connected for ≥ 3 months. Replacement of the knotted seton significantly decreased pain (P<0.001) and discharge (P = 0.024) measured by the PDAI. Furthermore, 71% reported less cleaning problems. Eight patients developed a perianal abscess. Five patients required a re-intervention.
The SuperSeton is a feasible novel technique with promising short term results. Drainage of perianal fistulas by the SuperSeton might be preferred over the conventional knotted seton.