NCT05893342

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

May 29, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

Preoperative frailtyPostoperative complications

Outcome Measures

Primary Outcomes (2)

  • Prevalence of frailty

    Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital

    First preoperative day

  • Postoperative complications

    Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality

    90 postoperative days

Secondary Outcomes (2)

  • Postoperative evolution

    90 postoperative days

  • Functional independence

    First postoperative year

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 65 years old undergoing surgery will be visited 24 hours before the intervention to sign the informed consent and the preoperative evaluation will be carried out through the application of different scales that evaluate the frailty of the patient. The patient will be monitored from his admission to the hospital until discharge and up to 3 months after the day of surgery. Data will be collected on in-hospital complications (medical or surgical), days of hospital stay, unforeseen need for ICU admission, if there has been loss of instrumental or cognitive abilities, and in-hospital mortality data and up to 3 months after surgery.

You may qualify if:

  • Patients over 65 years old undergoing urgent or scheduled surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

RECRUITING

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ángel Becerra, PhD

    Hospital Universitario de Gran Canaria Doctor Negrín

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ángel Becerra, PhD

CONTACT

Aurelio Rodriguez-Pérez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 7, 2023

Study Start

March 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations