Wiesenberger Rico, Müller Julian, Kaufmann Mario, Weiß Christel, Ghezel-Ahmadi David, Hardt Julia, Reissfelder Christoph, Herrle Florian
Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Institute for Medical Statistics, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Langenbecks Arch Surg. 2024 Apr 22;409(1):134. doi: 10.1007/s00423-024-03321-z.
Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization.
This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count).
97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298).
MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial.
This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".
早期活动是加速康复外科（ERAS®）路径的重要组成部分。然而，很大一部分患者未能达到ERAS®推荐的目标（术后第1天/POD1下床活动360分钟）。动机性访谈（MI）是以患者为中心的循证咨询方式，旨在促进内在动力。本研究旨在评估MI是否能改善术后活动情况。
这项双臂、患者盲法的先导随机对照试验纳入了接受择期肠道切除术的ERAS®患者。谈话通过MI治疗完整性验证。使用两个经过验证的运动传感器（movisens）和自我评估来测量活动情况（POD1 - POD3：下床时间、站立时间和步数）。
共筛查97例患者，最终纳入60例并随机分组。在POD1 - 3期间，干预组（IG）累计下床时间长于对照组（CG）（中位数：685分钟对420分钟；p = 0.022）。IG在POD1 - 3期间更频繁地达到ERAS®每天360分钟的目标（27.4%对10.61%；p = 0.013）。IG的每日站立时间为131.5分钟（每POD中位数），而CG为95.8分钟/天（p = 0.212），IG的每日步数为1347步，CG为754步/天（p = 0.298）。
MI实施门槛低且患者接受度良好。在ERAS®背景下，MI可改善活动情况。尽管表现更佳，但应注意，干预组中只有27.4%的患者达到了ERAS®每天360分钟的合规目标。这项先导研究的结果表明，需在多中心优势试验中进一步测试MI在围手术期的显著效果。
本研究于2022年2月25日在德国临床试验注册中心进行前瞻性注册。试验注册号为“DRKS00027863”。
