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临床试验/NCT05387850
NCT05387850已完成不适用

Association of Clinical Frailty Assessment With Adverse Postoperative Outcomes and Quality of Life in Elderly Non-cardiac Surgery Patients: a Prospective Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12,000
试验地点
1
主要终点
mortality

研究概览

简要总结

The frailty index may represent a useful decision support tool to optimize modifiable drivers of the quality and cost of digestive surgery care. However, classical indices are cumbersome to compute and often require unavailable data. The number of operations in the elderly is gradually increasing, and the prevention and treatment of adverse postoperative outcomes has become the focus of clinical attention. More recently, clinicians have focused more on the association between frailty and adverse postoperative outcomes, but this has not been rigorously applied to long-term prospective studies in older patients.

详细描述

As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice as non-elderly patients, and mortality rates are five times higher than non elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly in an optimal perioperative period.

Elderly patients continue to pose a major threat to the world's rapidly ageing population due to high rates of surgery and postoperative complications in elderly patients. Therefore, optimizing perioperative management strategies for elderly patients remains one of the biggest challenges facing clinicians.

Frailty is a multidimensional clinical syndrome characterized by vulnerability to dependence and increased mortality when exposed to stressors. It is often clinically described as a lack of physiological reserve, manifested as a loss of physical ability, metabolic function, and cognitive abilities. A systematic review of studies of patients in general surgery reported that the prevalence of prefrailty was estimated to be between 11.3% and 45.8%, while the prevalence of frailty was estimated to be between 10.4% and 37.0%.

Although clinicians or relatives may be aware of frailty, there is currently no standardized clinical gold-standard assessment tool to widely use and quantify frailty.

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 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Geriatric surgical patients ≥65 years old
  • non-selective cardiac surgery

排除标准

  • Missing or incomplete patient follow-up records
  • ASA degree V
  • Delirium before surgery
  • Patient refused to enroll

结局指标

主要结局

mortality

时间窗: up to 1 month

postoperative all-cause mortality

次要结局

  • the incidence of postoperative delirium(During hospitalization (up to 1 month))
  • postoperative sleep quality(6 months after surgery)
  • anxiety state and postoperative depression state(12 months)
  • postoperative quality of life evaluation(12 months)
  • postoperative depression state (PHQ-9) Scale)(12 months)
  • adverse postoperative outcomes(up to 1 month)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

研究点 (1)

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