Clinical trial NCT05594277: Frailty and Surgery
Official title: The Impact of Hospitalization After Major Surgery on Elderly Frail Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery
timeFrame: Three months
Secondary outcomes:
measure: Necessity of domiciliary care assistance
timeFrame: Three months
measure: Re-hospitalization or rehabilitation center admissions
timeFrame: Three months
measure: Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status
timeFrame: Three months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: AOU Maggiore della Carità
Study officials:
affiliation: Università degli Studi del Piemonte Orientale Amedeo Avogadro
name: Rosanna Vaschetto, Professor
role: STUDY_CHAIR
References: