Frailty, Anesthesia and Complications.

NCT ID: NCT04264351

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

413 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc Sanitari Pere Virgili

OTHER

Sponsor Role collaborator

Fundacio Puigvert

OTHER

Sponsor Role lead

Responsible Party

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Merce Prieto Butillé

MD, Anesthesiology consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergi Sabate, MD PhD

Role: STUDY_DIRECTOR

Chair Anesthesiologist at Fundació Puigvert

Locations

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Fundació Puigvert

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FRAC1

Identifier Type: -

Identifier Source: org_study_id

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