主要腹部手术后使用与不使用健身追踪器反馈的术后并发症和活动能力：一项由学生主导的多中心随机对照试验（CHIR-Net SIGMA 研究小组）的研究方案。
Postoperative complications and mobilisation following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS): study protocol for a student-led multicentre randomised controlled trial (CHIR-Net SIGMA study group).
机构信息
Faculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Health Data Science Unit, University Hospital Heidelberg, BioQuant, Im Neuenheimer Feld 267, 69120, Heidelberg, Germany.
出版信息
Trials. 2020 Mar 23;21(1):293. doi: 10.1186/s13063-020-4220-8.
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.
背景
尽管手术技术和围手术期护理取得了进步，但大腹部手术后仍经常发生术后并发症。提倡早期和强化的术后活动以减少术后并发症，但它是否可以独立改善大手术后的结果仍不清楚。健身追踪器（FT）是一种有前途的工具，可以改善术后活动，但它们对术后并发症和恢复的影响尚未在临床试验中进行研究。
方法
这是一项多中心随机对照试验，有两个平行的研究组，评估在接受择期大腹部手术的患者中，强化和早期活动方案与基于 FT 的反馈相结合的效果。参与者以 1:1 的比例随机分配到实验组或对照组。实验组每天设定目标步数，FT 提供关于每日步数的反馈；对照组根据医院标准进行活动。对照组也配备了 FT，但屏幕是黑屏，因此无法提供基于 FT 的反馈。随机化将按手术类型（腹腔镜与开放）进行分层。研究的主要终点是 30 天内的术后发病率，通过综合并发症指数来衡量。次要终点包括步数以及一系列功能、发病率和安全性参数。总共将在 15 个德国中心招募 348 名患者。该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实施简单的活动方案与基于 FT 的反馈相结合是否可以降低接受大腹部手术的患者的术后发病率。如果是这样，FT 将提供一种具有成本效益的干预措施，以增强术后活动并改善患者的结果。
试验注册
德国临床试验注册（DRKS，德国临床研究注册）：DRKS00016755，UTN U1111-1228-3320。于 2019 年 3 月 6 日注册。
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