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Enhanced Perioperative Mobilization (EPM) Trial — EPMIII  

Liver Resection Clinical Trial

Official title:
Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial

Clinical Trial Summary

Randomized Controlled Trial to monitor and increase the postoperative mobilization of the patients undergoing major visceral surgery by giving a continuous autofeedback of the step count using activity tracking wristbands.

Clinical Trial Description

Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach, pancreas and liver for any indication will be included. Further inclusion criteria are: age between 18-75 years, ASA score < 4, and a signed informed consent. Patients are stratified into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an autofeedback of their step-count using an activity tracker wristband or for the control group without autofeedback. Sample size (n = 29 patients in each of the four groups, overall n = 119) is calculated on an assumed difference in step-count of 250 steps daily (intervention versus control group). The primary study endpoint is the step-count during the first five postoperative days; secondary endpoints are the percentage of patients in the two groups, who master the predefined mobilization (step-count) targets, the assessment of additional activity data from the devices, the assessment of the preoperative mobility, length of hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day mortality, and the overall 30-day morbidity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02834338
Study type Interventional
Source Technische Universität Dresden
Contact
Status Completed
Phase N/A
Start date July 26, 2016
Completion date July 20, 2017
View Details
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