Frailty, Anesthesia and Complications. (FRAC)

Frailty, Anesthesia and Complications in an Urological Setting.

Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Postoperative Delirium; Complication of Surgical Procedure; Physical Disability; Anesthesia Complication

Detailed Description

Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.

Methods: prospective cohort study performed at Fundació Puigvert. Enrollment of 850 patients ≥70 y/o who undergo scheduled nephrourologic surgery. In the preoperative visit frailty is going to be evaluated using the Short Physical Performance Battery (SPPB), the Canadian Frailty Scale, the Mini-Cog test (Memory an executive functions), the Pfeiffer Test (Cognitive global screening), an involuntary loss of more than 4.5kg or 5% of weight in the previous year and physical activity using the Metabolic Equivalents of Task (MET). We will analyse the relation among frailty, medical, surgical postoperative complications and mortality at 30 days, 6 months and one year after the surgery.

The results will be adjusted by the possible confounding and interaction variables using a multivariate logistic regression model. The confounding /interaction variables will include demographic data, clinical and lab data and events arisen during the follow-up period.

• Study Type: Observational
• Enrollment (Actual): 413

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing urological scheduled surgery in our centre, that fill in the inclusion criteria with no exclusion criteria.

Description

Inclusion criteria

• Patients who participate voluntarily
• Signed Informed consent
• 70+ years old
• Scheduled urological surgery with general or regional anesthesia and length of stay in hospital over 24 hours.
• Patients with preserved domiciliary deambulation without aid of another person. (walking sticks, or walkers are accepted)

Exclusion Criteria:

• No signing of the informed consent
• Surgery performed with local anesthetics
• Day surgery, extracorporeal wave lithotripsy or endourological catheterism
• Advanced diagnosed dementia
• Patients with chronic advanced disease or terminal oncological disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty as a risk factor of postoperative events.	Assessment the prevalence of frailty in the surgical settings defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems. Frailty is defined as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss	2017-2021
Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery	Frailty is going to be evaluated in the anesthetic preoperative visit using the Short Physical Performance Battery (SPPB), Canadian Frailty Scale, Mini-Cog test (Memory an executive functions), Pfeiffer Test (Cognitive global screening), Involuntary loose of more than 4,5kg or 5% of weight in the previous year, physical activity using the Metabolic Equivalents of Task (MET).	2017-2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative events and frailty	Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.	2017-2021
Mortality associated to frailty and its complications	Assessment of the association between frailty and mortality at 30 days, 6 months and one year after the surgery.	2017-2021
Preoperative visit as a chance to assess frailty	Analyze which frailty evaluation tool works better in the preoperative visit setting.	2017-2021

Collaborators and Investigators

• Sponsor: Fundacio Puigvert
• Collaborators: Parc Sanitari Pere Virgili
• Investigators: Study Director: Sergi Sabate, MD PhD, Chair Anesthesiologist at Fundació Puigvert

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: complications; Anesthesia; Frailty
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Frailty; Emergence Delirium
• Other Study ID Numbers: FRAC1

Drug and device information, study documents

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