跳至主要内容
临床试验/NCT05893342
NCT05893342招募中不适用

Perioperative Frailty and Postoperative Complications: a Prospective Study

Dr. Negrin University Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
138
试验地点
1
主要终点
Prevalence of frailty

研究概览

简要总结

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 138 patients are being included. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

详细描述

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. This is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 138 patients. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. The secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to ICU areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (Frailty Clinical Scale, Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index). Considering that the estimated percentage of frailty is 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate the prevalence of frailty in the population.

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

入选标准

  • Patients over 65 years old undergoing urgent or scheduled surgery

排除标准

  • Language barrier
  • Cognitive impairment or inability to assist in clinical assessment during the study
  • Refusal to participate in the study

结局指标

主要结局

Prevalence of frailty

时间窗: First preoperative day

Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital

Postoperative complications

时间窗: 90 postoperative days

Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality

次要结局

  • Functional independence(First postoperative year)
  • Postoperative evolution(90 postoperative days)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Dr. Negrin University Hospital

研究点 (1)

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