NCT02613728已完成不适用
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cumulative Hospital Length of Stay (LOS)
研究概览
简要总结
The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner.
RecoverMI includes the following parts:
- Preoperative Education
- Early oral intake
- Early mobilization
- Telemedicine
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is the same, better, or worse than the other group.
- If you are assigned to Group 1, you will receive standard enhanced care after your surgery.
- If you are assigned to Group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and Telemedicine. Participants will be loaned an iPad to use for video-conferencing and text messaging in this study.
This is an investigational study. The study doctor can explain how RecoverMI is designed to work.
Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
- •Patient is >/= 18 years and younger than 80 years.
- •Elective minimally invasive operation.
- •No planned ostomy creation at time of enrollment.
- •Serum creatinine <1.5 measured within 30 days of surgery.
- •Ability to speak, read, and understand English.
排除标准
- •Strong, self-reported history of postoperative nausea and vomiting.
- •History of congestive heart failure. Systolic heart failure defined as Ejection Fraction (EF) </= 40%), or diastolic heart failure defined as EF >40% PLUS systemic manifestation of heart failure.
结局指标
主要结局
Cumulative Hospital Length of Stay (LOS)
时间窗: 30 days post transplant
次要结局
- Failure Rate (FR) in the RecoverMI Arm(30 days)
- Patient Satisfaction(30 days)
研究者
研究点 (2)
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