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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05594277
Other study ID # 421/CE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date October 31, 2023

Study information

Verified date March 2024
Source Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - = 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy AOU Maggiore della Carità Novara

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery 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 Three months
Secondary Necessity of domiciliary care assistance Necessity of domiciliary care assistance activation following hospital discharge after major surgery Three months
Secondary Re-hospitalization or rehabilitation center admissions Necessity of re-hospitalization or rehabilitation center admissions in the three months after major surgery Three months
Secondary Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status 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 based on the type of anesthesia used in major surgery Three months
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