跳至主要内容
临床试验/NCT05594277
NCT05594277已完成不适用

The Impact of Hospitalization After Major Surgery on Elderly Frail Patients: a Prospective Observational Study

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年5月1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
150
试验地点
1
主要终点
Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery

研究概览

简要总结

Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Frailty has been often used to characterize the weakest and most vulnerable subset of older adults, because of age, comorbidities, social and emotional status leading to the lack of functional and psychological reserve and mining the capability to face acute events. Frail patients are becoming ever more present in Anesthesia and Intensive Care. In fact, 30 percent of surgery is conducted on patients ≥ 70 years old nowadays. It has been demonstrated that the impact of surgery and anesthesiologic risk are greater in older frail subjects, and that a low functional status is associated with increased mortality. Also, post-operative delirium and cognitive disfunction are more often seen in older patients. For this reason, the worsening of the global performance status, as functional status, mobility, and cognitive status may have a large impact on patient and caregivers' life. The primary objective is to evaluate the impact at three months after hospitalization following major surgery i.e., urology, general surgery, orthopedics, on the performance status as functional status, mobility, and cognitive status of patients ≥ 70 years old. Secondary objectives are to evaluate the necessity of domiciliary care assistance and re-hospitalization or rehabilitation center admissions in three months following surgery and to evaluate the impact of the type of anesthesia used in major surgery i.e., general vs regional anesthesia, on patient performance status.

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

入选标准

  • ≥ 70 years old
  • Listed for major surgery in general and vascular surgery, urology, orthopedics
  • Patient General Practitioner listed in the Local Health Authority of Novara

排除标准

  • Barthel index at baseline < 16 in the activities of daily living section
  • Barthel index at baseline < 11 in the mobility section
  • Mini mental state examination at baseline < 11

结局指标

主要结局

Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery

时间窗: Three months

Ten-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and worsening of the mini mental state examination three months after surgery

次要结局

  • Necessity of domiciliary care assistance(Three months)
  • Re-hospitalization or rehabilitation center admissions(Three months)
  • Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status(Three months)

研究者

发起方
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Moretto

Medical doctor, physician

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

研究点 (1)

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