Frailty, Anesthesia and Complications.

Completed

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

• Registration Number: NCT04264351
• Lead Sponsor: Fundacio Puigvert

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Primary Completion: 2021-02
• Study Completion: 2023-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery	2017-2021	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).
Frailty as a risk factor of postoperative events.	2017-2021	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

Secondary Outcome Measures

Name	Time	Method
Mortality associated to frailty and its complications	2017-2021	Assessment 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 frailty	2017-2021	Analyze which frailty evaluation tool works better in the preoperative visit setting.
Postoperative events and frailty	2017-2021	Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.

Trial Locations

Locations (1)

Fundació Puigvert; 🇪🇸 Barcelona, Spain