Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 25
- 主要终点
- Post operative morbidity à 30-day
研究概览
简要总结
schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.
详细描述
Primary outcome :
Post-operative morbidity at 30-day :
Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0, and Complications grade 2.3.4 will be analyzed from day 1, at day 20 up to day 30.
Evaluation :
Pre operative : Day -30 to Day 0, Post operative : Day 10, Day 30, Day 90, Day 360.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient 70 years and more
- •Lung tumour of clinical staging I to IIIB receiving curative lung resection
排除标准
- •Diagnosis of non small lung cancer invalidated by the histological findings of the operative sample
- •psychological conditions, social support or geographical conditions not allowing the study follow up
- •Pre operative chemotherapy or radiotherapy
结局指标
主要结局
Post operative morbidity à 30-day
时间窗: March 2014
Post operative morbidity at 30-day : Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0. Complications grade 2.3.4 will be analyzed from day 1 up to day 30, collected at Day 1,Day 10, Day 30. A data collection is scheduled at Day 90 for delayed complications. Evaluation : preoperative at Day-30 up to Day 0, Postoperative at Day 10, day 30, Day 90, Day 360.
次要结局
- Length of post operative hospital stay(March 2014)
- Post operative mortality(March 2014)
- Length of intensive care unit stay(March 2014)