Clinical trial NCT02834338: Enhanced Perioperative Mobilization (EPM) Trial
Official title: Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Resection
Liver Resection
Gastric Resection
Colorectal Resection
Keywords: activity tracking
postoperative recovery
ERAS
fast-track surgery
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median Step count
timeFrame: First to fifth postoperative day
Secondary outcomes:
measure: Percentage of patients, who master the predefined mobilization (step-count) targets
timeFrame: First to fifth postoperative day
measure: Distance (km)
timeFrame: First to fifth postoperative day
measure: Activity time (min.)
timeFrame: First to fifth postoperative day
measure: inactivity
timeFrame: First to fifth postoperative day
measure: calorie consumption (kcal)
timeFrame: First to fifth postoperative day
measure: Compliance
timeFrame: First to fifth postoperative day
measure: Assessment of the preoperative mobility
timeFrame: Preoperative
measure: Length of hospital stay
timeFrame: 30 days
measure: Length of ICU stay
timeFrame: 30 days
measure: Amount of patients which receive physiotherapy
timeFrame: First to fifth postoperative day
measure: Mortality
timeFrame: 30 days
measure: Overall morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
Study officials:
affiliation: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany
name: Thilo Welsch, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.