Frailty, Anesthesia and Complications. (FRAC)
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|ClinicalTrials.gov Identifier: NCT04264351|
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
|Condition or disease|
|Frail Elderly Syndrome Anesthesia Complication Complication of Surgical Procedure Postoperative Delirium Physical Disability|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||850 participants|
|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|
- 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
- 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).
- 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.
- 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.
- Preoperative visit as a chance to assess frailty [ Time Frame: 2017-2021 ]Analyze which frailty evaluation tool works better in the preoperative visit setting.
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
|Contact: Mercè Prieto Butillé, MD||+34934169700 ext firstname.lastname@example.org|
|Contact: Silvia Mateu, MD||+34934169700 ext email@example.com|
|Study Director:||Sergi Sabate, MD PhD||Chair Anesthesiologist at Fundació Puigvert|