Frail-Negrin: Frailty in the Perioperative Period

• Sponsor: Dr. Negrin University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05893342
• Collaborator: University of Las Palmas de Gran Canaria (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 20.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Diagnostic Test: Preoperative frailty diagnostic

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Frailty and Postoperative Complications: a Prospective Study
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Outcome Measures

Primary Outcome Measures

1. Prevalence of frailty [First preoperative day]

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

2. 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

1. Postoperative evolution [90 postoperative days]

   To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.

2. Functional independence [First postoperative year]

   To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas	Spain	35019

Sponsors and Collaborators

• Dr. Negrin University Hospital
• University of Las Palmas de Gran Canaria

Investigators

• Principal Investigator: Ángel Becerra, PhD, Hospital Universitario de Gran Canaria Doctor Negrín

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
• ClinicalTrials.gov Identifier: NCT05893342
• Other Study ID Numbers: 2019-343-1
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 8, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital: Preoperative frailty; Postoperative complications
• Additional relevant MeSH terms: Frailty; Postoperative Complications

Study Results

No Results Posted as of Jun 8, 2023