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临床试验/NCT04655651
NCT04655651已完成不适用

Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2020年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
the score of comprehensive complication index(CCI)

研究概览

简要总结

Elderly people often have comorbidities. However, there could be a big difference in their health status. Frailty is considered to be relevant to adverse outcomes. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. Therefore it is important to design a research and help to solve this problem.

详细描述

With an aging population and the improvement of medical technology, the number of elderly patients who need surgery is gradually increasing. Elderly people often have comorbidities, malnutrition, and other conditions leading to an increased risk of anesthesia. What's more, there could be a big difference in the health status of the elderly with the same age. Frailty is considered to be highly prevalent with increasing age and to confer high risk for adverse outcomes. A complete evaluation of elderly patients before surgery may help improve the prognosis. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. In this study, we plan to use a comprehensive preoperative frailty assessment and follow up for 30 days after surgery to explore the effect of preoperative frailty on postoperative complications in the elderly after major surgeries. To better evaluate the postoperative complications, we choose comprehensive complication index (CCI), which integrates all complication of the Clavien-Dindo classification and offers a metric approach to measure morbidity.

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

入选标准

  • Aging at least 65 years old.
  • Scheduled for major surgery in Peking Union Medical College Hospital .
  • Understand and be willing to participate in this research, and can provide written informed consent.

排除标准

  • Underwent major surgery within the last month.
  • Can't complete the scale evaluation because of lower limb disability or severe knee osteoarthritis and other conditions that affect walking or climbing stairs.
  • With mental or neurological disorders and unable to cooperative with investigators.
  • Reject to sign the informed consent.

结局指标

主要结局

the score of comprehensive complication index(CCI)

时间窗: 30 days after surgery

CCI is based on the complication grading by Clavien-Dindo Classification and can be calculated online (https://www.assessurgery.com).

次要结局

  • the incidence of postoperative pulmonary complications(PPCs)(30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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