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Clinical Trials/NCT05893342
NCT05893342
Recruiting
N/A

Perioperative Frailty and Postoperative Complications: a Prospective Study

Dr. Negrin University Hospital1 site in 1 country138 target enrollmentMarch 1, 2024
ConditionsFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Dr. Negrin University Hospital
Enrollment
138
Locations
1
Primary Endpoint
Prevalence of frailty
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 138 patients are being included. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

Detailed Description

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. This is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 138 patients. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. The secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to ICU areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (Frailty Clinical Scale, Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index). Considering that the estimated percentage of frailty is 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate the prevalence of frailty in the population.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
September 30, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Negrin University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Dr. Negrin University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients over 65 years old undergoing urgent or scheduled surgery

Exclusion Criteria

  • Language barrier
  • Cognitive impairment or inability to assist in clinical assessment during the study
  • Refusal to participate in the study

Outcomes

Primary Outcomes

Prevalence of frailty

Time Frame: First preoperative day

Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital

Postoperative complications

Time Frame: 90 postoperative days

Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality

Secondary Outcomes

  • Functional independence(First postoperative year)
  • Postoperative evolution(90 postoperative days)

Study Sites (1)

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