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Frailty in the Perioperative Period

Perioperative Frailty and Postoperative Complications: a Prospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05893342
Acronym
Frail-Negrin
Enrollment
138
Registered
2023-06-07
Start date
2024-03-01
Completion date
2025-09-30
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

Preoperative frailty, Postoperative complications

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.

Interventions

DIAGNOSTIC_TESTPreoperative 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.

Sponsors

University of Las Palmas de Gran Canaria
CollaboratorOTHER
Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of frailtyFirst preoperative dayPrevalence of frailty in patients older than 65 years undergoing surgery in our hospital
Postoperative complications90 postoperative daysRelationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality

Secondary

MeasureTime frameDescription
Postoperative evolution90 postoperative daysTo evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.
Functional independenceFirst postoperative yearTo assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.

Countries

Spain

Contacts

Primary ContactÁngel Becerra, PhD
angbecbol@gmail.com+34676229025
Backup ContactAurelio Rodriguez-Pérez, PhD
arodperp@gobiernodecanarias.org+34928450371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026