Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative recovery
研究概览
简要总结
The purpose of the study is to investigate whether an extended program (ERAS 3.0) initiated hospital discharge, can improve recovery in elderly, frail patients who have undergone surgery for colon cancer.
The study is a randomised controlled trial with two groups: an intervention group receiving the ERAS 3.0 program and a control group recieving standard care. The ERAS 3.0 program includes a comprehensive geriatric health assessment, dietary counseling from a dietitian, and instructions on training and physical activity. These activities will take place in the participant's homes after hospital discharge. Data will be collected at multiple time points: at the hospital, 12 days post-discharge (at the outpatient clinic), and at 1 and 3 months post discharge in the participants' homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Frailty Scale preoperative score 4-7
- •Nutritional Risk Screening tool (NRS 2002) > 3
- •Elective colonic resection
- •No stoma planned
- •Minimally invasive surgical approach (laparoscopic or robotic)
- •Patients discharged to own home
- •Informed consent to participate
排除标准
- •Stoma creation during index surgery
- •Conversion to laparotomy
- •Major complications following surgery (Clavien-Dindo >3a)
- •Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project
- •Discharged with tube feeding and parenteral nutrition (partially or completely)
- •Known food allergies to dairy or any other ingredient contained in the nutrition package
- •Incapable of providing informed consent
- •Discharge to 24-hour municipal rehabilitation facility
- •All conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol
- •Neoadjuvant radio- or chemotherapy
研究组 & 干预措施
ERAS 3.0 group
Post-surgery support at discharge and at home
干预措施: ERAS 3.0 (Enhanced Recovery After Surgery) (Other)
Standard care group
Standard care, which is no support after discharge
结局指标
主要结局
Postoperative recovery
时间窗: 10-14 days after surgery
Postoperative recovery is measured as a change in the Quality of Recovery-15 questionnaire. Through 15 questions, the time spent in common postoperative conditions during the last 24 hours is estimated. Each question has a scale from 0 to 10, resulting in a maximum total score of 150.
次要结局
- Total length of hospital stay(within 6 months after discharge)
- Health realted Quality of Life (HrQoL)(12, 30 and 90 days after surgery)
- Postoperative recovery(30 and 90 days after surgery)
- Activities of daily living(12, 30 and 90 days after surgery)
- Energy- and protein intake(12, 30 and 90 days after surgery)
- Appetite(12, 30 and 90 days after surgery)
- Weight(12, 30 and 90 days after surgery)
- Physical function and muscle strenght(12, 30 and 90 days after surgery)
- Muscle mass by BIA(12, 30 and 90 days after surgery as well as 1 (CT) and 3 (CT) years after surgery)
- Rate of readmission(within 30 days after discharge)
- Postoperative complications(within 30 and 90 days after discharge)
- Number of reoperations(within 1 and 6 months after discharge)
- Days alive and out of the hospital(within 30 and 90 days after discharge)
- Mortality(Within 1, 3, 6, and 12 months after primary surgery)
- Muscle mass by CT(at baseline, after one and three years)
研究者
Elna A. Dalsgaard
MSc, ph.d. student
Copenhagen University Hospital at Herlev