Comparison of Preoperative Multimodal Preparation Program (Prehabilitation) With Enhanced Recovery Program for Elective Colorectal Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Number of days spent on ICU (Intensive care unit).
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.
Prehabilitation Program is a recently introduced trimodal 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.
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 (1:1) 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
- Triple (Care Provider, 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 —（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
结局指标
主要结局
Number of days spent on ICU (Intensive care unit).
时间窗: within 45 days postoperative
Number of days observed on ICU right after operation.
Length of hospital stay
时间窗: within 45 days
Postoperative length of hospital stay in days.
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.
30-day mortality
时间窗: 30 days postoperative
30-day mortality of each patient will be recorded.
90-day mortality
时间窗: 90 days postoperative
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 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)
Change in preoperative functional status - FVC by operation
时间窗: Measured points: 4 weeks before surgery, on day of hospital admission
FVC (forced vital capacity) will be measured.
Change in preoperative functional status - FVC by the end of rehabilitation
时间窗: Measured points: 4 weeks before surgery, 8 weeks after operation
FVC (forced vital capacity) will be measured.
次要结局
- Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).(within 8 weeks, if adjuvant oncotherapy is needed)
研究者
Dr. Balázs Bánky PhD
Head of the Department of Surgery, St. Borbala Hospital
St. Borbala Hospital