Enhanced Perioperative Mobilization (EPM) Trial (EPMIII)

Technische Universität Dresden

Status: Completed

Conditions: Pancreatic Resection; Liver Resection; Colorectal Resection; Gastric Resection

Treatments: Device: activity tracking for autofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02834338

TW-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 4 patient groups

Laparoscopic surgery, control

No Intervention group

Description:

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 group

Description:

activity tracking for autofeedback

Treatment:

Device: activity tracking for autofeedback

Open surgery, control

No Intervention group

Description:

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 group

Description:

activity tracking for autofeedback

Treatment:

Device: activity tracking for autofeedback