P551 Smooth Seton® for perianal fistulas: a knot-less solution

Abstract

the use of CS for at least 30 and 90 days were assessed in the primary randomized population regardless of baseline CS use. Similarly, CSfree remission and CS-free response were also assessed at wk 44 in pts who were receiving CS at enrollment baseline. Results: A significantly greater proportion of pts in the UST 90mg q8w group (46.9%, p=0.004) and a nominally significant greater proportion of pts in the 90mg q12w group (42.6%, p=0.035) were in CS-free remission at wk 44 compared with the PBO group (29.8%) ( Table). Likewise, a greater proportion of pts in the UST 90mg q12w group (51.2%, p=0.024) and 90mg q8w group (50.8%, p=0.026) were in CS-free response at wk 44 compared with pts the PBO group (36.6%). The proportions of pts in the PBO group that were in remission and off CS for 30 and 90 days (29.8% and 29%, respectively) were lower than in the 90mg q12w (42.6% and 41.1%, respectively) and 90mg q8w group (46.9% and 45.3%, respectively; p<0.05 for all comparisons vs PBO). Among the subgroup of pts receiving CS at baseline (44.8%), a greater proportion of these pts in the combined UST group discontinued CS and achieved clinical remission or clinical response at wk 44 (30.2% and 33.6%, respectively) compared with the PBO group (15.5% and 19.0%, respectively; p<0.05 for both). A numerically higher proportion of pts in each of the two dosing groups (q12w and q8w) achieved CS-free remission and response at wk 44 compared with PBO. Conclusions: UST achieved a higher rate of CS-free remission and response vs. PBO and this CS-sparing effect was observed over 44 wks of treatment. For pts on CS at study entry, UST showed evidence of benefit reducing the need for CS while still achieving clinical response/remission. Background: Perianal fistulas are a common incapacitating problem. Many patients are treated by seton drainage to prevent recurrent abscess formation. For centuries, a vessel loop or suture has been used for seton drainage. The knot (or suture) that is necessary to tie both ends together, is well known for causing complaints interfering with daily quality of life. To inventory complaints associated with knotted setons, a web-based questionnaire was performed by the Dutch Crohn and Ulcerative Colitis Association (CCUVN). Twenty-four out of 46 patients (52%) reported to have daily complaints of pain, irritation, itchiness or discharge caused by the knot. Medishield B.V. designed a knotless seton, the Smooth Seton, in order to decrease these complaints. With this study we aim to determine the advantages of a Smooth Seton for patients with perianal fistulas. Methods: A prospective cohort study was performed in a consecutive series of fistula patients. All patients ≥18 years, with perianal fistulas and a seton in situ, or patients presenting with a new perianal fistula, and no defunctioning stoma, were eligible. Existing setons were replaced at the outpatient clinic whereas new setons were placed at the operating theatre in day care setting. The primary outcome was seton failure (loosening of the connection). Se...