Enhanced Perioperative Mobilization (EPM) Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Resection, Liver Resection, Gastric Resection, Colorectal Resection

Intervention / Treatment
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* Device: activity tracking for autofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Laparoscopic surgery, control<br>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<br>activity tracking for autofeedback | Device: activity tracking for autofeedback<br>* 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.<br>|
| No Intervention: Open surgery, control<br>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<br>activity tracking for autofeedback | Device: activity tracking for autofeedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Overall morbidity | According the Clavien-Dindo classification | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activity tracking, postoperative recovery, ERAS, fast-track surgery