Frailty in the Perioperative Period

NCT ID: NCT05893342

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-09-30

Brief Summary

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 138 patients are being included. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

Detailed Description

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. This is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 138 patients. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. The secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to ICU areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (Frailty Clinical Scale, Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index). Considering that the estimated percentage of frailty is 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate the prevalence of frailty in the population.

Conditions

Frailty

Study Design

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

Interventions

Preoperative frailty diagnostic

The preoperative evaluation of the patient will be carried out through the application of different scales that evaluate frailty (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index) and a postoperative follow-up will be carried out for the diagnosis of complications during the first 90 postoperative days.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients over 65 years old undergoing urgent or scheduled surgery

Exclusion Criteria

• Language barrier
• Cognitive impairment or inability to assist in clinical assessment during the study
• Refusal to participate in the study

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ángel Becerra, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Gran Canaria Doctor Negrín

Locations

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ángel Becerra, PhD

Role: CONTACT

angbecbol@gmail.com

+34676229025

Aurelio Rodriguez-Pérez, PhD

Role: CONTACT

arodperp@gobiernodecanarias.org

+34928450371

Facility Contacts

Ángel Becerra, MD

Role: primary

+34676229025

Role: backup

angbecbol@gmail.com

Other Identifiers

2019-343-1

Identifier Type: -

Identifier Source: org_study_id