Clinical trial NCT04264351: Frailty, Anesthesia and Complications.
Official title: Frailty, Anesthesia and Complications in an Urological Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Anesthesia Complication
Complication of Surgical Procedure
Postoperative Delirium
Physical Disability
Keywords: Frailty
Anesthesia
complications
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Pere Virgili
First posted: 2020-02-11
Enrollment: 413
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing urological scheduled surgery in our centre, that fill in the inclusion criteria with no exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frailty as a risk factor of postoperative events.
timeFrame: 2017-2021
measure: Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery
timeFrame: 2017-2021
Secondary outcomes:
measure: Postoperative events and frailty
timeFrame: 2017-2021
measure: Mortality associated to frailty and its complications
timeFrame: 2017-2021
measure: Preoperative visit as a chance to assess frailty
timeFrame: 2017-2021
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Puigvert
Study officials:
affiliation: Chair Anesthesiologist at Fundació Puigvert
name: Sergi Sabate, MD PhD
role: STUDY_DIRECTOR
References: