Frailty, Anesthesia and Complications.

NCT04264351 | Completed

• 1 other identifier: FRAC1
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Frailty; Anesthesia; complications

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Postoperative events and frailty

  2017-2021

• Mortality associated to frailty and its complications

  2017-2021

• Preoperative visit as a chance to assess frailty

  2017-2021

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Patients who participate voluntarily
• Signed Informed consent
• + 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio Puigvert: lead
• Parc Sanitari Pere Virgili: collaborator

Study Sites (1)

Fundació Puigvert

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Emergence Delirium; Frailty

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sergi Sabate, MD PhD

  Chair Anesthesiologist at Fundació Puigvert

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology consultant

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: February 11, 2020
• Study Start: January 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: January 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

ES (1)