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Completed

NCT Number: NCT04264351

Frailty, Anesthesia and Complications.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frailty as a risk factor of postoperative events.

    Time frame: 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

  2. Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery

    Time frame: 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).

Secondary outcomes

  1. Postoperative events and frailty

    Time frame: 2017-2021

    Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.

  2. Mortality associated to frailty and its complications

    Time frame: 2017-2021

    Assessment of the association between frailty and mortality at 30 days, 6 months and one year after the surgery.

  3. Preoperative visit as a chance to assess frailty

    Time frame: 2017-2021

    Analyze which frailty evaluation tool works better in the preoperative visit setting.

Sponsors and collaborators

Lead sponsor

Fundacio Puigvert

Other

Collaborators

  • Parc Sanitari Pere Virgili

Registry information

Official study title

Frailty, Anesthesia and Complications in an Urological Setting.

Acronym: FRAC

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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