Prehabilitation in patients undergoing colorectal surgery fails to confer reduction in overall morbidity: results of a single-center, blinded, randomized controlled trial.

BACKGROUND: Currently, there are solely weak recommendations in the enhanced recovery after surgery (ERAS) protocol regarding the role of preoperative physical activity and prehabilitation in patients undergoing colorectal surgery. Studies in heterogenous groups showed contradictory results regarding the impact of prehabilitation on the reduction of postoperative complications. The aim of this study was to assess 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, 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 prehabilitation enhanced recovery after colorectal surgery [pERACS] group and 53 in the control group) were included in the study and randomized. Dropout rate was 4.5% (n = 5). Baseline characteristics were comparable between the pERACS and control groups. The percentage of colorectal adenocarcinoma was low in both groups (pERACS 32% vs. control 23%, p = 0.384). Almost all patients underwent minimally invasive surgery in both groups (96% vs. 98%, p = 1.000). There was no between-group difference in the primary outcome, as the mean CCI at 30-day postoperative in the pERACS group was 18 (SD 0-43) compared to 15 (SD 0-49) in the control group (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 groups. CONCLUSIONS: Routine physiotherapeutic prehabilitation has no additional benefit for patients undergoing colorectal surgery within an ERAS protocol. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT02746731; Institution Ethical Board Approval: KEK-ZH Nr. 2016-00,229.

Association of a prehabilitation program with anxiety and depression before colorectal surgery: a post hoc analysis of the pERACS randomized controlled trial.

PURPOSE: Hospital-associated anxiety and depression are major preoperative stressors and common in colorectal cancer surgery and major abdominal surgery. The prehabilitation Enhanced Recovery After Colorectal Surgery (pERACS) study is a single-center, single-blinded randomized controlled trial (RCT) evaluating the effect of a structured prehabilitation program. We evaluate within this RCT the association of a prehabilitation program with anxiety and depression before colorectal surgery. METHODS: Treatment allocation randomized and single-blinded. Regardless of group allocation, patients were treated according to our institutional Enhanced Recovery After Surgery (ERAS) protocol. Inclusion criteria consisted of adult patients suffering from colorectal disease requiring surgical treatment and who were treated according to the ERAS protocol. Anxiety and depression scores were assessed at baseline and at admission according to the Hospital Anxiety and Depression Scale (HADS), with its subcomponents for depression (HADS-D) and for anxiety (HADS-A). RESULTS: A total of 23 patients randomized to prehabilitation (mean age: 64.8±11.5 years) and 25 patients randomized to the control group (64.0±11.9 years) were included. There was no statistically significant difference in HADS-Anxiety improvement (Prehabilitation: -1.7±2.8 points vs. control: -0.4±3.4 points, p=0.132). Similarly, the difference in HADS-Depression improvement among the prehabilitation (1.0±2.4 points) and control (-0.3 ± 4.0 points) groups (p = 0.543) was non-significant. Clinically meaningful improvement in anxiety (60.9%/40.0%, p=0.149) and depression (34.8%/20.0%, p=0.250) was similar among the groups. CONCLUSION: In a post hoc analysis of a randomized trial, prehabilitation had no effect on preoperative reduction of anxiety and depression measures. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT02746731. Date of registration: April 21, 2016.

Mobilization of Mechanically Ventilated Patients in Switzerland.

PURPOSE: Growing evidence suggests that early mobilization benefits intensive care unit (ICU) patients. However, national practices and the culture of individual ICUs influence mobilization activities. MATERIALS AND METHODS: In a 1-day, Swiss point prevalence study conducted in 35 ICUs (representing 45% of all ICUs), the highest level of mobilization for mechanically ventilated patients was characterized using the validated ICU Mobility Scale, along with data collection for potential safety events and mobilization barriers. RESULTS: Among 161 mechanically ventilated patients, a total of 33% (n = 53) had active mobilization, with walking achieved by only 2% (n = 4). More severe organ failure was associated with lower mobilization (respiratory Sequential Organ Failure Assessment score: P = .037, cardiac: P = .008, neurology: P < .001). Barriers to mobilization were reported in 71% (n = 115), with deep sedation significantly higher among patients receiving passive versus active mobilization (14% vs 0%, P = .005). Potential safety events occurred in 20% (n = 33) of patients without significant differences between passive and active mobilization. Availability of physiotherapists and appropriate equipment were not reported barriers. CONCLUSION: Mobilization during mechanical ventilation occurred infrequently with greater organ failure associated with lower mobilization. Addressing the identified modifiable barriers via structured efforts to achieve multidisciplinary culture change is essential to decrease the common use of bed rest in Swiss ICUs.

Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge).