Enhanced Perioperative Mobilization (EPM) Trial (EPMIII)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Resection; Colorectal Resection; Pancreatic Resection; Gastric Resection
• Intervention / Treatment: Device: activity tracking for autofeedback

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01309
    • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Laparoscopic surgery, control; The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.
Active Comparator: Laparoscopic surgery, intervention; activity tracking for autofeedback	Device: activity tracking for autofeedback; The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.
No Intervention: Open surgery, control; The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.
Active Comparator: Open surgery, intervention; activity tracking for autofeedback	Device: activity tracking for autofeedback; The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median Step count	First to fifth postoperative day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Thilo Welsch, MD, MBA, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany

Publications and helpful links

General Publications

• Wolk S, Linke S, Bogner A, Sturm D, Meissner T, Mussle B, Rahbari NN, Distler M, Weitz J, Welsch T. Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Jun;23(6):1218-1226. doi: 10.1007/s11605-018-3998-0. Epub 2018 Oct 8.
• Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2016
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: ERAS; postoperative recovery; fast-track surgery; activity tracking
• Other Study ID Numbers: TW-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO