Trials / Completed

CompletedNCT04264351

Frailty, Anesthesia and Complications.

Frailty, Anesthesia and Complications in an Urological Setting.

Status: Completed
Phase: —
Study type: Observational
Enrollment: 413 (actual)

Sponsor: Fundacio Puigvert · Academic / Other
Sex: All
Age: 70 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Timeline

Start date: 2017-01-01
Primary completion: 2021-02-01
Completion: 2023-01-01
First posted: 2020-02-11
Last updated: 2023-09-18

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04264351. Inclusion in this directory is not an endorsement.