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Frailty, Anesthesia and Complications. (FRAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264351
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Parc Sanitari Pere Virgili
Information provided by (Responsible Party):
Merce Prieto Butillé, Fundacio Puigvert

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.

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

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Frailty, Anesthesia and Complications in an Urological Setting.
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264351


Contacts
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Contact: Mercè Prieto Butillé, MD +34934169700 ext 4569 cutxiprieto@gmail.com
Contact: Silvia Mateu, MD +34934169700 ext 1146 smateu@fundacio-puigvert.es

Locations
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Spain
Fundació Puigvert Recruiting
Barcelona, Spain, 08025
Contact: Merce Prieto Butillé, MD    +34934169700 ext 4569    cutxiprieto@gmail.com   
Contact: Silvia Mateu, MD    +34934169700 ext 1146    smateu@fundacio-puigvert.es   
Sponsors and Collaborators
Fundacio Puigvert
Parc Sanitari Pere Virgili
Investigators
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Study Director: Sergi Sabate, MD PhD Chair Anesthesiologist at Fundació Puigvert

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Responsible Party: Merce Prieto Butillé, MD, Anesthesiology consultant, Fundacio Puigvert
ClinicalTrials.gov Identifier: NCT04264351    
Other Study ID Numbers: FRAC1
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merce Prieto Butillé, Fundacio Puigvert:
Frailty
Anesthesia
complications
Additional relevant MeSH terms:
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Delirium
Frailty
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs