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NCT Number: NCT05893342

Frailty in the Perioperative Period

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ángel Becerra

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

Location status: Recruiting

Location contact

Ángel Becerra, MD

CONTACT

+34676229025

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative frailty diagnostic

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of frailty

    Time frame: First preoperative day

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

  2. Postoperative complications

    Time frame: 90 postoperative days

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

Secondary outcomes

  1. Postoperative evolution

    Time frame: 90 postoperative days

    To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.

  2. Functional independence

    Time frame: First postoperative year

    To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelio Rodriguez-Pérez, PhD

CONTACT

[email protected]

+34928450371

Ángel Becerra, PhD

CONTACT

[email protected]

+34676229025

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • University of Las Palmas de Gran Canaria

Registry information

Official study title

Perioperative Frailty and Postoperative Complications: a Prospective Study

Acronym: Frail-Negrin

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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