Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Median Step count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •emergency surgery
- •mental inability to complete postoperative assessment protocols
- •preoperatively immobile patients
研究组 & 干预措施
Laparoscopic surgery, control
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
activity tracking for autofeedback
干预措施: activity tracking for autofeedback (Device)
Open surgery, control
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
activity tracking for autofeedback
干预措施: activity tracking for autofeedback (Device)
结局指标
主要结局
Median Step count
时间窗: First to fifth postoperative day
次要结局
- Percentage of patients, who master the predefined mobilization (step-count) targets(First to fifth postoperative day)
- Distance (km)(First to fifth postoperative day)
- Activity time (min.)(First to fifth postoperative day)
- inactivity(First to fifth postoperative day)
- calorie consumption (kcal)(First to fifth postoperative day)
- Compliance(First to fifth postoperative day)
- Assessment of the preoperative mobility(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(30 days)