Frailty and Surgery

March 3, 2024 updated by: Francesca Moretto, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

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

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.

Study Overview

Status

Completed

Conditions

Frail Elderly Syndrome

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Novara, Italy, 28100
    - Aou Maggiore Della Carita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients affering to Maggiore della Carità University Hospital and Local Health Authority of Novara, Italy, listed for major surgery in general and vascular surgery, urology, orthopedics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
surgical elderly patients Patients ≥ 70 years old, undergoing a major surgery in general and vascular surgery, urology, orthopedics at Maggiore della Carità University Hospital, Novara, Italy, having a General Practitioner listed in the Local Health Authority of Novara.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery Time Frame: 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	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Necessity of domiciliary care assistance Time Frame: Three months	Necessity of domiciliary care assistance activation following hospital discharge after major surgery	Three months
Re-hospitalization or rehabilitation center admissions Time Frame: Three months	Necessity of re-hospitalization or rehabilitation center admissions in the three months after major surgery	Three months
Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status Time Frame: 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 based on the type of anesthesia used in major surgery	Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Investigators

Study Chair: Rosanna Vaschetto, Professor, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria