Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
Dresden, 01309, Germany
NCT Number: NCT02834338
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Dresden, 01309, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: First to fifth postoperative day
Time frame: First to fifth postoperative day
Time frame: First to fifth postoperative day
Assessed by the activity tracker wristband
Time frame: First to fifth postoperative day
Assessed by the activity tracker wristband
Time frame: First to fifth postoperative day
Assessed by the activity tracker wristband
Time frame: First to fifth postoperative day
Assessed by the activity tracker wristband
Time frame: First to fifth postoperative day
Compliance to wear the wrist band
Time frame: Preoperative
Measured by International Physical Activity Questionnaire (IPAQ)
Time frame: 30 days
Time frame: 30 days
Time frame: First to fifth postoperative day
Time frame: 30 days
Time frame: 30 days
According the Clavien-Dindo classification
Technische Universität Dresden
Other
Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial
Acronym: EPMIII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03688867
Pancreatic Resection, Preoperative Frailty
Cleveland, Ohio, United States
View Trial DetailsNCT03891225
Biological Dressing, Pancreatic Resection
Peschiera del Garda, Verona, Italy
View Trial DetailsNCT07180641
Hepatectomy, Liver Metastases
View Trial DetailsNCT06980792
Digestive System Diseases, Digestive System Neoplasms
Modena, Italy
View Trial Details