Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Days Alive and out of Hospital (DAOH)
研究概览
简要总结
Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.
详细描述
Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
- •Planned urinary diversion with an ileal conduit
- •Age ≥ 65 years.
- •Patients considered frail by G8 screening tool (total score ≤14).
排除标准
- •Patients who refuse or are not able to provide informed consent.
- •Patients who do not speak or understand Danish.
- •Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
结局指标
主要结局
Days Alive and out of Hospital (DAOH)
时间窗: Within 90 days after cystectomy
Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications.
次要结局
- Length of stay(Within 90 days after surgery)
- Complications(Within 30 and 90 days after cystectomy)
- Mortality(Within 30 and 90 days after cystectomy)
- Chair stand test (CST)(3 weeks postoperatively)
- Days Alive and out of Hospital (DAOH)(Within 30 days after cystectomy)
- Hospital readmissions(Within 30 and 90 days after cystectomy)
- Patient Quality of Life(Within 30 and 90 days postoperatively)
研究者
Jørgen Bjerggaard Jensen
Professor, DMSc
Aarhus University Hospital