Frailty in the Perioperative Period

Recruiting

• Conditions: Frailty

• Registration Number: NCT05893342
• Lead Sponsor: Dr. Negrin University Hospital

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).

Study Timeline

• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-07
• Study Start: 2024-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of frailty	First preoperative day	Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital
Postoperative complications	90 postoperative days	Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality

Secondary Outcome Measures

Name	Time	Method
Functional independence	First postoperative year	To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.
Postoperative evolution	90 postoperative days	To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.

Trial Locations

Locations (1)

Ángel Becerra; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain