Frailty and Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Frail Elderly Syndrome

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgical elderly patients<br>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?
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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 | Absolute and five-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and the absolute and five-point 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 | Necessity of domiciliary care assistance activation following hospital discharge after major surgery | Three months | 
| Re-hospitalization or rehabilitation center admissions | 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 | Absolute and five-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and the absolute and five-point worsening of the mini mental state examination three months after surgery based on the type of anesthesia used in major surgery | Three months |