Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer. Randomized Open-label Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in functional status after colorectal cancer surgery between groups
研究概览
简要总结
Health establishments encourage the development of specific care pathways for the elderly by supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a clear reduction in mortality and the number of re-hospitalizations in patients 6 months after their care. The multidisciplinary approach of global management of the patient in the perioperative period aims to reduce surgical stress as well as the rapid restoration of previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved rehabilitation after colorectal surgery, care programs are not specific to the geriatric population and geriatric assessment criteria to describe the functional status of patients are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment following colorectal surgery, on the evolution of several clinical parameters such as: functional status, morbidity mortality, quality of life, and lifestyle. The study investigators hypothesize that management in the GPOU for colorectal cancer surgery in patients aged 70 and over will improve functional status at 3 months, in comparison with traditional management. The proposed intervention should also lead to an improvement in patient satisfaction with care, complications and re-hospitalizations, nutritional status, lifestyle and patient survival.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or their representative must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •Diagnosis of proven colorectal cancer.
- •Patient to benefit from scheduled colorectal surgery at the University Hospital of Nîmes validated in digestive surgery SPC after oncogeriatric evaluation.
- •Surgical act: resection with anastomosis in one step.
排除标准
- •Interventional RIPH patient defined as category 1 if there is interference with the primary endpoint
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
结局指标
主要结局
Change in functional status after colorectal cancer surgery between groups
时间窗: Baseline and Month 3
Instrumental Activities of Daily Living (IADL) score (score 0-8)
次要结局
- Change in basic functional status between groups(Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6)
- Patient satisfaction with care between groups(Hospital discharge (an average of 10 days))
- The number of medical complications during hospitalization between groups(Hospital discharge (an average of 10 days))
- Change in the patient's place of abode between groups(Month 1, Month 3 and Month 6)
- Change in functional status between groups(Baseline and Month 6)
- Change in patient motor ability between groups(Baseline, Month 3)
- Patient quality of life between groups(Month 6)
- The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups(Month 1)
- Length of hospital stay between groups(Hospital discharge (an average of 10 days))
- The distribution of surgical complications between groups(Month 1)
- Destination of patients on discharge from hospital between groups(Hospital discharge (an average of 10 days))
- The change in the patient's weight between groups(Baseline and Month 3)
- Overall survival between groups.(Month 6)