Enhanced Perioperative Mobilization (EPM) Trial

Not Applicable

Completed

• Conditions: Pancreatic Resection; Colorectal Resection; Gastric Resection; Liver Resection
• Interventions: Device: activity tracking for autofeedback

• Registration Number: NCT02834338
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Study Start: 2016-07-26
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• elective laparoscopic and open surgery of the colon and rectum (colectomy, hemicolectomy, segment resection, rectum extirpation, deep anterior rectum resection, sigmoid resection, proctocolectomy), of the stomach (total, subtotal and atypical gastric resections), of the pancreas (any kind of pancreatic resections), and of the liver (hemihepatectomy, atypical resection, anatomical segment resection)
• ASA score < IV
• completed informed consent.

Exclusion Criteria

• emergency surgery
• mental inability to complete postoperative assessment protocols
• preoperatively immobile patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery, intervention	activity tracking for autofeedback	activity tracking for autofeedback
Open surgery, intervention	activity tracking for autofeedback	activity tracking for autofeedback

Primary Outcome Measures

Name	Time	Method
Median Step count	First to fifth postoperative day

Secondary Outcome Measures

Name	Time	Method
Overall morbidity	30 days	According the Clavien-Dindo classification
Percentage of patients, who master the predefined mobilization (step-count) targets	First to fifth postoperative day
Distance (km)	First to fifth postoperative day	Assessed by the activity tracker wristband
Activity time (min.)	First to fifth postoperative day	Assessed by the activity tracker wristband
inactivity	First to fifth postoperative day	Assessed by the activity tracker wristband
calorie consumption (kcal)	First to fifth postoperative day	Assessed by the activity tracker wristband
Compliance	First to fifth postoperative day	Compliance to wear the wrist band
Assessment of the preoperative mobility	Preoperative	Measured by International Physical Activity Questionnaire (IPAQ)
Length of hospital stay	30 days
Length of ICU stay	30 days
Amount of patients which receive physiotherapy	First to fifth postoperative day
Mortality	30 days

Trial Locations

Locations (1)

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden; 🇩🇪 Dresden, Germany