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Frailty, Anesthesia and Complications.

Frailty, Anesthesia and Complications in an Urological Setting.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04264351
Acronym
FRAC
Enrollment
413
Registered
2020-02-11
Start date
2017-01-01
Completion date
2023-01-31
Last updated
2023-09-18

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

Conditions

Anesthesia Complication, Complication of Surgical Procedure, Frail Elderly Syndrome, Physical Disability, Postoperative Delirium

Keywords

Frailty, Anesthesia, complications

Brief summary

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.

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.

Interventions

None listed

Sponsors

Parc Sanitari Pere Virgili
CollaboratorOTHER
Fundacio Puigvert
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Frailty as a risk factor of postoperative events.2017-2021Assessment 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
Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery2017-2021Frailty 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).

Secondary

MeasureTime frameDescription
Postoperative events and frailty2017-2021Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.
Mortality associated to frailty and its complications2017-2021Assessment of the association between frailty and mortality at 30 days, 6 months and one year after the surgery.
Preoperative visit as a chance to assess frailty2017-2021Analyze which frailty evaluation tool works better in the preoperative visit setting.

Countries

Spain

Outcome results

None listed

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