确定每日术后步数目标和通过健身追踪器 (FT) 的反馈是否可以降低术后并发症的发生率。一直主张早期和加强术后活动以减少术后并发症，但尚不清楚单独 FT 是否可以降低发病率。由学生主导的临床试验网络 SIGMA 在德国 11 所大学医院进行。接受腹部大手术的患者被纳入，配备了 FT，并随机分配到实验组（可见屏幕）或对照干预组（黑屏）。实验组通过英国《金融时报》收到每日步数目标和反馈。主要终点是使用综合并发症指数（CCI）计算的术后 30 天内的发病率。所有试验访问均由医院的医学生进行，并有机会咨询也获得知情同意的外科医生协助者。出院后，医学生通过电话和电子问卷进行术后30天回访，共纳入347例患者。两组之间的基线特征具有可比性。患者的平均年龄为 58 岁，71% 的患者因恶性疾病接受手术，最常见的适应症是胰腺、结直肠和肝胆恶性肿瘤。大约三分之一的患者接受了腹腔镜手术。由于数据完整性为 100%，因此无需对主要终点进行插补。意向治疗分析中两组之间的 CCI 无显着差异（平均值±SD CCI 实验组：23±24 对比对照组：22±22；95% CI：-6.1, 3.7；P= 0.628）。两组之间的所有次要结局，包括恢复质量、6 分钟步行测试、住院时间和术后第 7 天之前的步数，均具有可比性。每日步数目标与基于 FT 的反馈相结合，对术后发病率没有影响。 EXPELLIARMUS 表明医学生可以成功地进行外科随机对照试验。版权所有 © 2024 作者。由 Wolters Kluwer Health, Inc. 出版

To determine whether daily postoperative step goals and feedback through a fitness tracker (FT) reduce the rate of postoperative complications after surgery.Early and enhanced postoperative mobilization has been advocated to reduce postoperative complications, but it is unknown whether FT alone can reduce morbidity.EXPELLIARMUS was performed at 11 University Hospitals across Germany by the student-led clinical trial network SIGMA. Patients undergoing major abdominal surgery were enrolled, equipped with an FT, and randomly assigned to the experimental (visible screen) or control intervention (blackened screen). The experimental group received daily step goals and feedback through the FT. The primary end point was postoperative morbidity within 30 days using the Comprehensive Complication Index (CCI). All trial visits were performed by medical students in the hospital with the opportunity to consult a surgeon-facilitator who also obtained informed consent. After discharge, medical students performed the 30-day postoperative visit through telephone and electronic questionnaires.A total of 347 patients were enrolled. Baseline characteristics were comparable between the 2 groups. The mean age of patients was 58 years, and 71% underwent surgery for malignant disease, with the most frequent indications being pancreatic, colorectal, and hepatobiliary malignancies. Roughly one-third of patients underwent laparoscopic surgery. No imputation for the primary end point was necessary as data completeness was 100%. There was no significant difference in the CCI between the 2 groups in the intention-to-treat analysis (mean±SD CCI experimental group: 23±24 vs. control: 22±22; 95% CI: -6.1, 3.7; P=0.628). All secondary outcomes, including quality of recovery, 6-minute walking test, length of hospital stay, and step count until postoperative day 7 were comparable between the 2 groups.Daily step goals combined with FT-based feedback had no effect on postoperative morbidity. The EXPELLIARMUS shows that medical students can successfully conduct randomized controlled trials in surgery.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.