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BackgroundA 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.ObjectiveThe 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.MethodsThe 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.ResultsFollowing 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.ConclusionsThe 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.Trial RegistrationClinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge)

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Objective Patients undergoing major surgery are prone to a functional decline due to the impairment of muscle, cardiorespiratory and neurological function as a response to surgical stress. Currently, there are solely weak recommendations in the ERAS protocol regarding the role of preoperative physical activity and prehabilitation in patients undergoing colorectal surgery. Studies in heterogenous cohorts showed contradictory results regarding the impact of prehabilitation on the reduction of postoperative complications. This randomized controlled trial assesses the impact of prehabilitation on postoperative complications in patients undergoing colorectal surgery within an ERAS protocol. Methods Between July 2016 and June 2019, a single-center, single-blinded , randomized controlled trial designed to test whether physiotherapeutic prehabilitation vs. normal physical activities prior to colorectal surgery may decrease morbidity within a stringent ERAS protocol was carried out. The primary endpoint was postoperative complications assessed by Comprehensive Complications Index (CCI®). Primary and secondary endpoints for both groups were analyzed and compared. Results A total of 107 patients (54 in the pERACS and 53 in the control cohort) were included in the study and randomized. Dropout rate was 4.5% (n = 5). Mean age (SD) in the control cohort was 65 (29–86) and 66 (24–90) years in pERACS cohort. The pERACS cohort contained more female patients (40% vs. 55%, p = 0.123) and a higher percentage of colorectal adenocarcinoma (32% vs. 23%, p = 0.384) although not significant. Almost all patients underwent minimally invasive surgery in both cohorts (96% vs 98%, p = 1.000). There was no between-cohort difference in the primary outcome measure 30-day Comprehensive Complications Index (15 [0 – 49] vs. 18 [0 – 43], p = 0.059). Secondary outcome as complications assessed according to Clavien-Dindo, length of hospital stay, reoperation rate and mortality showed no difference between both cohorts. Conclusion Routine physiotherapeutic prehabilitation cannot be recommended for patients undergoing colorectal surgery within an ERAS protocol (Grade A recommendation). To eliminate other confounders like geographical difference or difference in surgical technique, further multicenter RCTs are needed.