BACKGROUND AND AIMS Most patients with perianal Crohn's fistula receive medical treatment with anti-TNF, while the results of anti-TNF treatment have not been directly compared to chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn's disease fistulas would result in less re-interventions, compared to anti-TNF and compared to surgical closure. METHODS This randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned to i) chronic seton drainage for 1 year, ii) anti-TNF therapy for 1 year, and iii) surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-intervention(s) at 1.5 year. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort. RESULTS Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate (10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, P = 0.02). No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure. CONCLUSIONS The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn's fistulas.The trial is registered with Trialregister.nl number NTR4137.

中文翻译：

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克罗恩病肛周瘘的治疗，Seton 与抗 TNF 与抗 TNF [PISA] 后的手术闭合：一项随机对照试验。

背景和目的 大多数肛周克罗恩瘘患者接受抗 TNF 药物治疗，而抗 TNF 治疗的结果尚未与慢性挂线引流或手术闭合直接比较。本研究的目的是评估与抗 TNF 和与手术闭合相比，肛周克罗恩病瘘管患者的慢性挂线引流是否会导致更少的再干预。方法 这项随机试验在 19 个欧洲中心进行。具有单个内部开口的高位肛周克罗恩瘘患者被随机分配到 i) 慢性挂线引流 1 年，ii) 抗 TNF 治疗 1 年，以及 iii) 2 个月后在短期抗 TNF 下手术闭合。主要结果是 1.5 年时与瘘管相关的再干预患者的累积数量。由于特定治疗偏好而拒绝随机化的患者被纳入平行的前瞻性 PISA 注册队列。结果 2013 年 9 月 14 日至 2017 年 11 月 20 日期间，126 名计划患者中的 44 名被随机分组​​。该研究因无效而被数据安全监察委员会终止。Seton 治疗与最高的再干预率相关（10/15，与 6/15 抗 TNF 和 3/14 手术闭合患者，P = 0.02）。观察到三个治疗组之间的肛周疾病活动和生活质量没有显着差异。有趣的是，在 PISA 前瞻性登记中，没有观察到慢性挂线治疗的劣势。