Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events.
详细描述
Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded.
The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty.
The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age not less than 65 years;
- •undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.
排除标准
- •Those who did not undergo surgery for various reasons;
- •Death before operation
结局指标
主要结局
Blood loss
时间窗: 2 year
intraoperative blood loss
postoperative complications
时间窗: 2 year
including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.
The length of stay in intensive care unit (ICU)
时间窗: 2 year
Time form entry to ICU to return to general ward after the condition is stable.
operative time
时间窗: 2 year
From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
The length of hospitalization
时间窗: 2 year
Time from admission to discharge
Hospital costs
时间窗: 2 year
Cost of diagnosis and treatment during hospitalization
Readmission rate within 30 days
时间窗: 2 year
The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.
Intraoperative complications
时间窗: 2 year
Including all the complications in the procedure
Mortality within 30 days
时间窗: 2 year
death rate within 30 days after surgery in all patients after operation
次要结局
- Recurrence-free Survival (RFS)(2 year)
- Overall survival (OS)(2 year)
研究者
Ziqiang Wang,MD
Clinical professor
West China Hospital