Frailty, Anesthesia and Complications.

Postoperative Delirium Clinical Trial

— FRAC  

Official title:

Frailty, Anesthesia and Complications in an Urological Setting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264351
• Other study ID #: FRAC1
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 2023

Study information

• Verified date: September 2023
• Source: Fundacio Puigvert
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: January 2023
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Complication of Surgical Procedure
• Emergence Delirium
• Frail Elderly Syndrome
• Frailty
• Physical Disability
• Postoperative Delirium

Locations

Country	Name	City	State
Spain	Fundació Puigvert	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Puigvert	Parc Sanitari Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Preoperative visit as a chance to assess frailty	Analyze which frailty evaluation tool works better in the preoperative visit setting.	2017-2021