FrailtyFrail-NegrinNCT05893342
Frailty in the Perioperative Period
An observational study of Frailty, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Preoperative frailty diagnostic
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Patients over 65 years old undergoing urgent or scheduled surgery
Who cannot join
- Language barrier
- Cognitive impairment or inability to assist in clinical assessment during the study
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Ángel Becerra
Las Palmas de Gran Canaria, Las Palmas, 35019
Ángel Becerra, MD, +34676229025
angbecbol@gmail.com
About this study
Official title: Perioperative Frailty and Postoperative Complications: a Prospective Study
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Preoperative frailty diagnostic
- Keywords
- Preoperative frailty, Postoperative complications
- Medical subject headings
- Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative frailty diagnosticDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty
Prevalence of frailty in patients older than 65 years undergoing surgery in our hospital
Measured: First preoperative day
Postoperative complications
Relationship of preoperative frailty in patients older than 65 years undergoing surgery in our hospital and postoperative mortality
Measured: 90 postoperative days
Secondary outcomes (2)
Postoperative evolution
To evaluate the association between frailty and increased days of hospitalization, hospital readmission and unexpected admission to ICU areas.
Measured: 90 postoperative days
Functional independence
To assess whether patients with greater frailty suffer a greater loss of postoperative functional independence.
Measured: First postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Responsible party
- Principal investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, PhD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893342
- Sponsor's protocol ID
- 2019-343-1
- Acronym
- Frail-Negrin
- Status last verified
- Aug 2025
- First submitted
- 29 May 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data could be available after request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Frailty and Postoperative Complications: a Prospective Study
- ClinicalTrials.gov ID
- NCT05893342
- Acronym / sponsor ID
- Frail-Negrin / 2019-343-1
- Conditions
- Frailty
- Keywords
- Preoperative frailty, Postoperative complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients over 65 years old undergoing urgent or scheduled surgery
Key exclusion criteria (3 listed)
- Language barrier
- Cognitive impairment or inability to assist in clinical assessment during the study
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative frailty diagnosticThe 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. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Postoperative evolution
Time frame: 90 postoperative days
Functional independence
Time frame: First postoperative year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data could be available after request to the principal investigator
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ángel Becerra, PhD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ángel Becerra, PhD (+34676229025, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of frailty (time frame: First preoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.