The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients. This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial. The ACCURE trial was designed as a multicentre, randomised controlled trial. UC patients with a new diagnosis or a disease relapse within the past 12 months, treated with 5-ASA, corticosteroids, or immunomodulators until complete clinical and endoscopic remission (defined as total Mayo score < 3 with endoscopic subscore of 0 or 1), were counselled for inclusion. Also, patients previously treated with biologicals who had a washout period of at least 3 months were considered for inclusion. Patients were randomised (1:1) to laparoscopic appendectomy plus maintenance treatment or a control group (maintenance therapy only). The primary outcome is the 1-year UC relapse rate (defined as a total Mayo-score ≥ 5 with endoscopic subscore of 2 or 3, or clinically as an exacerbation of symptoms and rectal bleeding or FCP > 150 or intensified medical therapy other than 5-ASA therapy). Secondary outcomes include number of relapses per patient, time to first relapse, disease activity, number of colectomies, medication usage, and health-related quality of life. The ACCURE trial will provide comprehensive evidence whether adding an appendectomy to maintenance treatment is superior to maintenance treatment only in maintaining remission in UC patients. Dutch Trial Register (NTR) NTR2883 . Registered May 3, 2011. ISRCTN, ISRCTN60945764 . Registered August 12, 2019.

中文翻译：

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ACCURE试验的临床统计分析计划：阑尾切除术对溃疡性结肠炎临床病程的影响，随机国际多中心试验

溃疡性结肠炎 (UC) 的主要治疗方法是采用标准升级方法进行药物治疗。阑尾切除术可能会调节 UC 的临床病程，降低复发率并减少药物需求。 ACCURE 试验的目的是评估除了标准药物治疗外，腹腔镜阑尾切除术在维持 UC 患者缓解方面的疗效。本文提出了评估 ACCURE 试验结果的统计分析计划。 ACCURE 试验被设计为一项多中心、随机对照试验。过去 12 个月内新诊断或疾病复发的 UC 患者接受 5-ASA、皮质类固醇或免疫调节剂治疗，直至临床和内镜完全缓解（定义为 Mayo 总评分 < 3，内镜分项评分为 0 或 1）建议纳入。此外，之前接受过生物制剂治疗且具有至少 3 个月清除期的患者也被考虑纳入。患者被随机（1:1）分配到腹腔镜阑尾切除术加维持治疗组或对照组（仅维持治疗）。主要结局是 1 年 UC 复发率（定义为 Mayo 总评分≥5，内镜分项评分为 2 或 3，或临床上症状恶化和直肠出血或 FCP > 150 或强化药物治疗除 5 之外） -ASA疗法）。次要结局包括每位患者的复发次数、首次复发时间、疾病活动性、结肠切除术次数、药物使用情况以及与健康相关的生活质量。 ACCURE 试验将提供全面的证据，证明在维持治疗中添加阑尾切除术是否优于仅维持 UC 患者的缓解治疗。荷兰审判登记册 (NTR) NTR2883 。注册日期：2011 年 5 月 3 日。ISRCTN，ISRCTN60945764。 2019 年 8 月 12 日注册。