Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery, control | No Intervention | The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out. | |
| Laparoscopic surgery, intervention | Active Comparator | activity tracking for autofeedback |
|
| Open surgery, control | No Intervention | The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out. | |
| Open surgery, intervention | Active Comparator | activity tracking for autofeedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activity tracking for autofeedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Step count | First to fifth postoperative day |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thilo Welsch, MD, MBA | Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden | Dresden | 01309 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30298422 | Derived | 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. | |
| 28222805 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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. |