Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Length of hospital stay
研究概览
简要总结
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.
ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.
Trimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.
This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.
Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.
详细描述
Aim:
Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.
In the prospective, randomized (2:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.
Study protocol in details:
First visit: Outpatient Department of 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and assessors will be blinded regarding preoperative preparation. Both randomization process and rehabilitation process will be carried out by a trained nurse, physiotherapist and psychotherapist, neither of them will be involved in outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with histologically proven primary colorectal adenocarcinoma
- •any stage of colorectal cancer
- •elective operation
- •curative intention
- •informed consent signed by patient
排除标准
- •emergency operation
- •palliative operation
- •non-colorectal, second malignancy
- •pregnancy
- •patient not giving consent
研究组 & 干预措施
ERAS + nutritional prehabilitation
Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.
干预措施: ERAS + nutritional prehabilitation (Procedure)
Trimodal prehabilitation + ERAS
Patients receiving a formal preoperative preparation on:
Physical status (walking, respiratory training) Nutrition (nutritional supplements) Mental status (weekly groups led by clinical psychologist on anxiety and depression management).
Each patient will be treated in an ERAS program preoperatively.
干预措施: Trimodal rehabilitation + ERAS (Procedure)
结局指标
主要结局
Length of hospital stay
时间窗: 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit).
时间窗: 45 days
Number of days observed on ICU right after operation.
Morbidity (early) classified after Clavien-Dindo.
时间窗: 7 days (until 8th postoperative day) postoperative
7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Morbidity (long term) classified after Clavien-Dindo.
时间窗: 30 days (until 31st postoperative day)
30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Change in postoperative functional status - 6MWD by the end of rehabilitation
时间窗: Measured points: 4 weeks before surgery, 8 weeks after operation
6MWD (6-minute walking distance test)
30-day mortality
时间窗: 30 days (until 31st postoperative day)
30-day mortality of each patient will be recorded.
90-day mortality
时间窗: 90 days (until 91st postoperative day)
90-day mortality of each patient will be recorded.
Change in preoperative functional status - 6MWD by operation
时间窗: Measured points: 4 weeks before surgery, on day of hospital admission
6MWD (6-minute walking distance test)
Change in preoperative functional status - FVC by operation
时间窗: Measured points: 4 weeks before surgery, on day of hospital admission
Measured points: 4 weeks before surgery, on day of hospital admission
Change in preoperative functional status - FVC by the end of rehabilitation
时间窗: Measured points: 4 weeks before surgery, 8 weeks after operation
Measured points: 4 weeks before surgery, 8 weeks after operation
次要结局
- Change of alpha- and beta-diversity of fecal microbata(Measured points: 4 weeks before surgery, on day of hospital admission and 8 weeks after surgery)