Frailty in the Perioperative Period

Frailty Clinical Trial

— Frail-Negrin  

Official title:

Perioperative Frailty and Postoperative Complications: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893342
• Other study ID #: 2019-343-1
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Dr. Negrin University Hospital
• Contact: Ángel Becerra, PhD
• Phone: +34676229025
• Email: angbecbol[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Postoperative Complications

Intervention

Diagnostic Test:
• Preoperative frailty diagnostic
The preoperative evaluation of the patient will be carried out through the application of different scales that evaluate frailty (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index) and a postoperative follow-up will be carried out for the diagnosis of complications during the first 90 postoperative days.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of frailty	Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital	First preoperative day
Primary	Postoperative complications	Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality	90 postoperative days
Secondary	Postoperative evolution	To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.	90 postoperative days
Secondary	Functional independence	To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.	First postoperative year