Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial.

BACKGROUND: 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.

DISCUSSION: 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.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02834338 . Registered on 15 June 2016.