Merki-Künzli Cornelia, Kerstan-Huber Marta, Switalla Denise, Gisi David, Raptis Dimitri Aristotle, Greco Nicola, Mungo Giuseppe, Wirz Markus, Gloor Severin, Misirlic Merima, Breitenstein Stefan, Tschuor Christoph
Department of Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland.
Institute of Physiotherapy, Cantonal Hospital Winterthur, Winterthur, Switzerland.
JMIR Res Protoc. 2017 Oct 27;6(10):e199. doi: 10.2196/resprot.7972.
A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications. To date, there are limited studies that investigate preoperative physical training combined with ERAS.
The aim of this study is to assess the impact of tailored physical training prior to colorectal surgery conducted according to an ERAS protocol on overall morbidity. This study proposes the initial hypothesis that 3-6 weeks of prehabilitation before elective colorectal surgery may improve postoperative outcome and reduce complication rates, assessed using the Comprehensive Complication Index. The primary objective is to evaluate overall morbidity due to postoperative complications. Additionally, complications are assessed according to the Clavien-Dindo classification, length of stay, readmission rate, mortality rate, and treatment-related costs.
The prehabilitation Enhanced Recovery After colorectal Surgery (pERACS) study is a single-center, single-blinded prospective randomized controlled trial. Patients scheduled for colorectal resections are randomly assigned either to the prehabilitation group or the control group. All patients are treated with the ERAS pathway for colorectal resections according to a standardized study schedule. Sample size calculation performed by estimating a clinically relevant 25% reduction of postoperative complications (alpha=.05, power 80%, dropout rate of 10%) resulted in 56 randomized patients per group.
Following ethical approval of the study protocol, the first patient was included in June 2016. At this time, a total of 40 patients have been included; 27 patients terminated the study by the end of March 2017. Results are expected to be published in 2018.
The pERACS trial is a single-center, single-blinded prospective randomized controlled trial to assess the impact of tailored physical training prior to colorectal surgery, conducted according to an ERAS protocol, in order to evaluate overall morbidity.
Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge).
在标准化的术后加速康复（ERAS）治疗路径的术后阶段，一个关键要素是活动。目前，ERAS指南中没有关于术前体育活动的建议。接受大手术的患者由于手术应激导致肌肉、心肺和神经功能受损，容易出现功能下降。研究表明，术前体育锻炼可减少术后并发症。迄今为止，研究术前体育锻炼与ERAS相结合的研究有限。
本研究旨在评估根据ERAS方案在结直肠手术前进行的个性化体育锻炼对总体发病率的影响。本研究提出初步假设，即择期结直肠手术前进行3 - 6周的预康复训练可能改善术后结局并降低并发症发生率，采用综合并发症指数进行评估。主要目的是评估术后并发症导致的总体发病率。此外，根据Clavien - Dindo分类、住院时间、再入院率、死亡率和治疗相关费用对并发症进行评估。
结直肠手术后预康复（pERACS）研究是一项单中心、单盲前瞻性随机对照试验。计划进行结直肠切除术的患者被随机分配到预康复组或对照组。所有患者均按照标准化研究方案接受结直肠切除术的ERAS治疗路径。通过估计术后并发症临床相关降低25%（α = 0.05，检验效能80%，失访率10%）进行样本量计算，每组得出56例随机患者。
研究方案获得伦理批准后，首例患者于2016年6月入组。此时，共纳入40例患者；截至2017年3月底，27例患者终止研究。结果预计于2018年发表。
pERACS试验是一项单中心、单盲前瞻性随机对照试验，旨在评估根据ERAS方案在结直肠手术前进行的个性化体育锻炼对总体发病率的影响。
Clinicaltrials.gov NCT02746731；https://clinicaltrials.gov/ct2/show/NCT02746731（由WebCite存档于http://www.webcitation.org/6tzblGwge）
