Clinical trial NCT05893342: Frailty in the Perioperative Period
Official title: Perioperative Frailty and Postoperative Complications: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Keywords: Preoperative frailty
Postoperative complications
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: University of Las Palmas de Gran Canaria
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 65 years old undergoing surgery will be visited 24 hours before the intervention to sign the informed consent and the preoperative evaluation will be carried out through the application of different scales that evaluate the frailty of the patient. The patient will be monitored from his admission to the hospital until discharge and up to 3 months after the day of surgery. Data will be collected on in-hospital complications (medical or surgical), days of hospital stay, unforeseen need for ICU admission, if there has been loss of instrumental or cognitive abilities, and in-hospital mortality data and up to 3 months after surgery.

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. 100 patients are being included for 3 months. 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 100 patients for 3 months. 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 (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index).

Eligibility criteria: Inclusion Criteria:

* Patients over 65 years old undergoing urgent or scheduled surgery for three months.

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of frailty
timeFrame: First preoperative day
measure: Postoperative complications
timeFrame: 90 postoperative days
Secondary outcomes:
measure: Postoperative evolution
timeFrame: 90 postoperative days
measure: Functional independence
timeFrame: First postoperative year
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Becerra, PhD
role: PRINCIPAL_INVESTIGATOR
References: