Colorectal Resection, Gastric Resection, Liver Resection, Pancreatic Resection
Conditions
Keywords
activity tracking, postoperative recovery, ERAS, fast-track surgery
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.
Interventions
DEVICEactivity 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.
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Step count | First to fifth postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance (km) | First to fifth postoperative day | Assessed by the activity tracker wristband |
| Activity time (min.) | First to fifth postoperative day | Assessed by the activity tracker wristband |
| inactivity | First to fifth postoperative day | Assessed by the activity tracker wristband |
| calorie consumption (kcal) | First to fifth postoperative day | Assessed by the activity tracker wristband |
| Compliance | First to fifth postoperative day | Compliance to wear the wrist band |
| Percentage of patients, who master the predefined mobilization (step-count) targets | First to fifth postoperative day | — |
| 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 | 30 days | According the Clavien-Dindo classification |
| Assessment of the preoperative mobility | Preoperative | Measured by International Physical Activity Questionnaire (IPAQ) |
Countries
Germany
Outcome results
None listed