Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Recurrence-free survival after surgery.
研究概览
简要总结
The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.
详细描述
Frailty is an age-related syndrome characterized with diminished physiological reserve that results in decreased homeostatic capacity and increased vulnerability to any stress from minor to major. Approximately 10% to 20% of adults aged 65 years and older present with frailty, and the incidence doubles among those of 85 years and older. Among elderly cancer patients especially those with digestive cancer, the prevalence of frailty and pre-frailty can be as high as 50%. Malnutrition often coexists with frailty, and indeed contribute to the development of frailty. As a matter of fact, the proportion of malnutrition also increases with age even in high-income countries.
Frailty is strongly associated with worsening outcomes in surgical patients, including higher delirium, high non-delirium complications, high perioperative mortality, as well as decreased activity of daily life, cognitive dysfunction and work disability in long-term survivors. Furthermore, malnutrition as a prominent factor in the development of frailty also has adverse impacts on the duration of hospitalization, complications, and survival after surgery. Therefore, it is urgently needed to understand how to enhance the recovery of these patients following surgery.
Exercises and rehabilitation, in combination with nutritional supplement, may reverse or mitigate frailty, promote postoperative recovery, and improve clinical outcomes. However, the reported effectiveness varies with interventions and are not sufficiently robust to guide good clinical practice. The purpose of this study is to investigate the effect of multimodal prehabilitation on early and long-term outcomes in elderly patients with frailty.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- •Inability to communicate due to coma, profound dementia, or language barrier;
- •Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
- •Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
- •Severe heart dysfunction (left ventricular ejection fraction <30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;
- •Other reasons that are considered unsuitable for study participation.
结局指标
主要结局
Recurrence-free survival after surgery.
时间窗: Up to two years after surgery.
Events include recurrence, metastasis, or all-cause death, whichever come first.
A composite of delirium and non-delirium complications within 7 days after surgery (sub-study).
时间窗: Up to 7 days after surgery.
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method. Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.
次要结局
- Incidence of delirium within 7 days after surgery (sub-study).(Up to 7 days after surgery.)
- Quality of life at 30 days after surgery (sub-study).(At 30 days after surgery.)
- Cancer specific survival after surgery.(Up to 2 years after surgery.)
- Physical activity at 30 days after surgery (sub-study).(At 30 days after surgery.)
- Incidence of non-delirium complication within 30 days after surgery (sub-study).(Up to 30 days after surgery.)
- Sleep quality at 30 days after surgery (sub-study).(At 30 days after surgery.)
- Overall survival after surgery.(Up to 2 years after surgery.)
- Intensive care unit admission after surgery (sub-study).(Up to 30 days after surgery.)
- Time to oral fluid intake after surgery (sub-study).(Up to 30 days after surgery.)
- Time to out-of-bed activity after surgery (sub-study).(Up to 30 days after surgery.)
- Time to oral food intake after surgery (sub-study).(Up to 30 days after surgery.)
- 6-minute walk distance at hospital discharge (sub-study).(At hospital discharge, up to 30 days after surgery.)
- Length of hospital stay after surgery (sub-study).(Up to 30 days after surgery.)
- All-cause 30-day mortality after surgery (sub-study).(Up to 30 days after surgery.)
- Cognitive function at 30 days after surgery (sub-study).(At 30 days after surgery.)
- Event-free survival after surgery.(Up to 2 years after surgery.)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital