NCT05848609招募中不适用
Prospective Evaluation of Functional Status and Quality of Life in Older Patients With Colorectal Cancer Undergoing Robotic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 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
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
- Re-operation and re-admission rate(< 30 days after surgery)
- 1-year disease free survival(1 year postoperatively)
- Postoperative confusion rate(7 days postoperative)
- 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)
- 1-year patient survival(1 year postoperatively)
- Comparison in outcome parameters between frail patients (abnormal screening) versus fit patients(up till 12 months postoperatively)
- Conversion-rate to open surgery(during surgery)
- 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)
- 90- day post-operative mortality(< 90 days postoperative)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
不适用
Prospective Robotic Global Research Study (PROGRESS)Lumbar Disc DiseaseNCT04257279Globus Medical Inc200
招募中
不适用
Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic CancerPancreatic Ductal AdenocarcinomaMinimally Invasive SurgeryNCT04211948Ruijin Hospital300
进行中（未招募）
不适用
Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic AlignmentOsteoarthritis, KneeNCT04912973Philip Winnock de Grave, MD80
招募中
1 期
Robot-assisted surgery to improve functional results following sphincter-preserving rectal cancer resection.C21.8Overlapping lesion of rectum, anus and anal canalDRKS00011328Chirurgische UniversitätsklinikKlinik für Allgemeine-, Viszerale- und Transplantationschirurgie100
进行中（未招募）
不适用
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) SystemColorectal LesionColorectal AdenomaColorectal PolypRectal LesionRectal AdenomaRectal PolypSigmoid Colon PolypLesion SigmoidNCT06133387EndoQuest Robotics, Inc.56