Frailty in the Perioperative Period (Frail-Negrin)

Perioperative Frailty and Postoperative Complications: a Prospective 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. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 100 patients are being included for 3 months. 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.

Study Overview

• Status: Recruiting
• Conditions: Frailty
• Intervention / Treatment: Diagnostic test: Preoperative frailty diagnostic

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 100 patients for 3 months. 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 (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ángel Becerra, PhD; Phone Number: +34676229025; Email: angbecbol@gmail.com
• Study Contact Backup: Name: Aurelio Rodriguez-Pérez, PhD; Phone Number: +34928450371; Email: arodperp@gobiernodecanarias.org

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Recruiting
      • Ángel Becerra
      • Contact: Ángel Becerra, MD; Phone Number: +34676229025
      • Contact: Email: angbecbol@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• Patients over 65 years old undergoing urgent or scheduled surgery for three months.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative evolution	To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.	90 postoperative days
Functional independence	To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.	First postoperative year

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital
• Collaborators: University of Las Palmas de Gran Canaria
• Investigators: Principal Investigator: Ángel Becerra, PhD, Hospital Universitario de Gran Canaria Doctor Negrin

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative complications; Preoperative frailty
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Postoperative Complications
• Other Study ID Numbers: 2019-343-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data could be available after request to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No