Wolk Steffen, Meißner Theresa, Linke Sebastian, Müssle Benjamin, Wierick Ann, Bogner Andreas, Sturm Dorothée, Rahbari Nuh N, Distler Marius, Weitz Jürgen, Welsch Thilo
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.
Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.
Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. "Early mobilization" is one such principle, but the quality of assessment and monitoring is poor, and evidence of improved outcome is lacking. Activity trackers allow precise monitoring and automatic feedback to the patients to enhance their motivation for early mobilization. The aim of the study is to monitor and increase the postoperative mobilization of patients by giving them continuous automatic feedback in the form of a step count using activity-tracking wristbands.
METHODS/DESIGN: Patients undergoing elective open and laparoscopic surgery of the colon, rectum, stomach, pancreas, and liver for any indication will be included. Further inclusion criteria are age between 18 and 75 years, American Society of Anesthesiologists Physical Status class less than IV, and a signed informed consent form. Patients will be stratified into two subgroups, laparoscopic and open surgery, and will be randomized 1:1 for automatic feedback of their step count using an activity tracker wristband. The control group will have no automatic feedback. The sample size (n = 30 patients in each of the four groups, overall n = 120) is calculated on the basis of an assumed difference in step count of 250 steps daily (intervention group versus control group). The primary study endpoint is the average step count during the first 5 postoperative days; secondary endpoints are the percentage of patients in the two groups who master the predefined mobilization (step count) targets, assessment of additional activity data obtained from the devices, assessment of preoperative mobility, length of hospital and intensive care unit stays, number of patients who receive physiotherapy, 30-day mortality, and overall 30-day morbidity.
Early mobilization is a key element of ERAS. However, enhanced early mobilization is difficult to define, to assess objectively, and to implement in clinical practice. Consequently, there is a discrepancy between ERAS targets and actual practice, especially in patients undergoing major visceral surgery. This study is the first randomized controlled trial investigating the use and feasibility of activity tracking to monitor and enhance postoperative early mobilization.
ClinicalTrials.gov identifier: NCT02834338 . Registered on 15 June 2016.
术后加速康复（ERAS）计划旨在通过实施多项围手术期原则，将术后应激降至最低并加速术后康复。“早期活动”就是这样一项原则，但评估和监测的质量较差，且缺乏改善预后的证据。活动追踪器可实现精确监测并向患者提供自动反馈，以增强他们早期活动的积极性。本研究的目的是通过使用活动追踪腕带以步数计数的形式为患者提供持续自动反馈，来监测并增加患者术后的活动量。
方法/设计：纳入因任何适应症接受结肠、直肠、胃、胰腺和肝脏择期开放手术及腹腔镜手术的患者。进一步的纳入标准为年龄在18至75岁之间、美国麻醉医师协会身体状况分级低于IV级且签署知情同意书。患者将被分为两个亚组，即腹腔镜手术组和开放手术组，并将以1:1的比例随机分配，使用活动追踪腕带自动反馈其步数计数。对照组将不接受自动反馈。样本量（四组每组n = 30例患者，共n = 120例）是根据假设的干预组与对照组每日步数计数相差250步来计算的。主要研究终点是术后前5天的平均步数计数；次要终点是两组中达到预定义活动量（步数计数）目标的患者百分比、对从设备获得的额外活动数据的评估、术前活动能力评估、住院时间和重症监护病房停留时间、接受物理治疗的患者数量、30天死亡率以及总体30天发病率。
早期活动是ERAS的关键要素。然而，强化早期活动难以定义、客观评估并在临床实践中实施。因此，ERAS目标与实际操作之间存在差异，尤其是在接受重大内脏手术的患者中。本研究是第一项调查使用活动追踪来监测和强化术后早期活动的随机对照试验。
ClinicalTrials.gov标识符：NCT02834338。于2016年6月15日注册。
