BACKGROUND Postoperative complications following major abdominal surgery are frequent despite progress in surgical technique and perioperative care. Early and enhanced postoperative mobilisation has been advocated to reduce postoperative complications, but it is still unknown whether it can independently improve outcomes after major surgery. Fitness trackers (FTs) are a promising tool to improve postoperative mobilisation, but their effect on postoperative complications and recovery has not been investigated in clinical trials. METHODS This is a multicentre randomised controlled trial with two parallel study groups evaluating the efficacy of an enhanced and early mobilisation protocol in combination with FT-based feedback in patients undergoing elective major abdominal surgery. Participants are randomly assigned (1:1) to either the experimental group, which receives daily step goals and a FT giving feedback about daily steps, or the control group, which is mobilised according to hospital standards. The control group also receives a FT, however with a blackened screen; thus no FT-based feedback is possible. Randomisation will be stratified by type of surgery (laparoscopic vs. open). The primary endpoint of the study is postoperative morbidity within 30 days measured via the Comprehensive Complication Index. Secondary endpoints include number of steps as well as a set of functional, morbidity and safety parameters. A total of 348 patients will be recruited in 15 German centres. The study will be conducted and organised by the student-led German Clinical Trial Network SIGMA. DISCUSSION Our study aims at investigating whether the implementation of a simple mobilisation protocol in combination with FT-based feedback can reduce postoperative morbidity in patients undergoing major abdominal surgery. If so, FTs would offer a cost-effective intervention to enhance postoperative mobilisation and improve patient outcomes. TRIAL REGISTRATION Deutsches Register Klinischer Studien (DRKS, German Clinical Trials Register): DRKS00016755, UTN U1111-1228-3320. Registered on 06.03.2019.

中文翻译：

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大型腹部外科手术后的并发症和动员，有无基于健身追踪器的反馈（EXPELLIARMUS）：一项由学生主导的多中心随机对照试验的研究方案（CHIR-Net SIGMA研究组）。

背景技术尽管在手术技术和围手术期护理方面取得了进展，但是在进行大腹部手术后仍经常发生术后并发症。提倡早期和加强术后动员以减少术后并发症，但仍不能独立改善大手术后的结局。健身追踪器（FTs）是改善术后动员的有前途的工具，但尚未在临床试验中研究其对术后并发症和恢复的影响。方法这是一个多中心随机对照试验，有两个平行的研究小组评估增强的早期动员方案与基于FT的反馈相结合对择期大腹部手术患者的疗效。参与者是随机分配的（1：1）要么是接受日常步数目标的实验组，要么是提供有关日常步数反馈的FT，要么是对照组，根据医院的标准动员起来。对照组也收到了FT，但屏幕变黑了。因此不可能有基于FT的反馈。随机化将根据手术类型（腹腔镜与开放式）进行分层。该研究的主要终点是通过综合并发症指数衡量的30天内的术后发病率。次要终点包括步骤数以及一组功能，发病率和安全性参数。将在德国的15个中心招募348位患者。这项研究将由学生领导的德国临床试验网络SIGMA进行和组织。讨论我们的研究旨在调查将简单的动员方案与基于FT的反馈相结合是否可以降低进行大腹部手术的患者的术后发病率。如果是这样，金融服务公司将提供一种具有成本效益的干预措施，以增强术后动员并改善患者预后。试用注册德国注册研究机构Klinischer Studien（DRKS，德国临床试验注册）：DRKS00016755，UTN U1111-1228-3320。注册于06.03.2019。德国临床试验注册）：DRKS00016755，UTN U1111-1228-3320。注册于06.03.2019。德国临床试验注册）：DRKS00016755，UTN U1111-1228-3320。注册于06.03.2019。