Frailty and Surgery

Frail Elderly Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594277
• Other study ID #: 421/CE
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Frail Elderly Syndrome

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