Frailty and Surgery

NCT05594277 | Completed

• 1 other identifier: 421/CE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Necessity of domiciliary care assistance

  Three months

• Re-hospitalization or rehabilitation center admissions

  Three months

• Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status

  Three months

Study Arms (1)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead

Study Sites (1)

AOU Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (1)

• Moretto F, Fracazzini M, Scotti L, Viarengo V, Gentilli S, Romito R, Volpe A, Leigheb M, Porta CM, Konrad P, Colombo D, Olivieri C, Della Corte F, Cammarota G, Vaschetto R. Major Elective Surgery Impact on Performance Status in Older Adults: A Prospective Observational Study. Health Sci Rep. 2025 Nov 2;8(11):e71438. doi: 10.1002/hsr2.71438. eCollection 2025 Nov.

  PMID: 41189953 DERIVED

Study Officials

• Rosanna Vaschetto, Professor

  Università degli Studi del Piemonte Orientale Amedeo Avogadro

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, physician

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: May 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

IT (1)