Frailty and Surgery

NCT ID: NCT05594277

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2023-10-31

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.

Conditions

Frail Elderly Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

Sponsor Role: lead

Responsible Party

Francesca Moretto

Medical doctor, physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosanna Vaschetto, Professor

Role: STUDY_CHAIR

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Locations

AOU Maggiore della Carità

Novara, , Italy

Countries

Italy

Other Identifiers

421/CE

Identifier Type: -

Identifier Source: org_study_id