Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in frailty status GFI status
研究概览
简要总结
The present study evaluates prospectively the impact of robotic surgery on functional outcome and quality of life in older patients that are operated for colorectal cancer;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •patients ≥ 70 years with colorectal cancer
- •eligible for colorectal surgery after multidisciplinary board evaluation and patient consent
排除标准
- •decline in cognitive function after geriatric evaluation
- •emergency surgery
- •life expectancy < 3 months
研究组 & 干预措施
Older patients with colorectal cancer
Patients undergo geriatric assessment including evaluation of cognitive function, functional status and quality of life
干预措施: Geriatric Assessment (Diagnostic Test)
结局指标
主要结局
Change in frailty status GFI status
时间窗: Before and 3-6-12 months after surgery
Measurement of functional status using the Groningen Frailty Indicator (GFI) Screening Tool (fTRST)
Change in Quality of Life
时间窗: Before and 3-6-12 months after surgery
Measurement of QoL using validated EORTC QoL questionnaire
Change in frailty status G8 status
时间窗: Before and 3-6-12 months after surgery
Measurement of functional status using the G8, Flemish version of the Triage Risk Screening Tool (fTRST)
次要结局
- 90- day post-operative mortality(< 90 days postoperative)
- Re-operation and re-admission rate(< 30 days after surgery)
- 1-year disease free survival(1 year postoperatively)
- Length of hospital stay(Immediate after surgery)
- 30- day post-operative morbidity (Clavien-Dindo classification)(< 30 days postoperative)
- Percentage of patients demonstrating a significant decrease/improvement of QoL at 3,6,12 months after surgery(3-6-12 months after surgery)
- Evolution of post-operative cognition(3, 6, 12 months post surgery)
- Postoperative confusion rate(7 days postoperative)
- 1-year patient survival(1 year postoperatively)
- Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients(up till 12 months postoperatively)
- Percentage (%) of patients demonstrating functional improvement at 3, 6 and 12 months after surgery(3-6-12 months after surgery)
- Percentage of patients demonstrating functional recovery at 12 months after initial func-tional decline after surgery(3-6-12 months after surgery)
- Conversion-rate to open surgery(during surgery)