Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
研究概览
简要总结
This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major abdominal surgery in 3+ weeks
- •English or Spanish speaking
排除标准
- •Unable to use smartphone
研究组 & 干预措施
Control Arm
Recommendations to follow Mediterranean diet and exercise regularly before surgery.
Prehab
This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
干预措施: POWER (Behavioral)
结局指标
主要结局
Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
时间窗: 90 days after surgery
The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com).
次要结局
- Change in 6 minute walk test(It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery)
研究者
Cindy Kin
Assistant Professor of Surgery
Stanford University