Frailty in Adult SurgeryNCT07367828
Validity of Frailty Screening Tools as a Measure for Postoperative Outcomes
An observational study of Frailty in Adult Surgery and Frailty Syndrome, run by University of Iceland at 1 site in Iceland.
Trial summary
Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgery
- What is being tested?
- Intermediate/major elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteIceland
- Study dates
- 20 Jan 2025to 21 Dec 2026
- How long will I take part?
- 1 Year
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study population will consist of all patients ≥70 years who present for preoperative assessment with an anesthesiologist at Landspitali before undergoing intermediate/major surgery, The National University Hospital of Iceland.
Who may be able to join
- Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.
- Patients assigned to undergo intermediate/major surgery
Who cannot join
- Not undergoing planned surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali - The national university hospital in Iceland.
Reykjavik, Hofudborgarsvaedid, 101
Martin I Sigurdsson, MD, PhD, +354-824-8282, martin@landspitali.is
Luis G Rabelo, BSc, +354-820-3587, luisg@landspitali.is
About this study
Official title: Feasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery
Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery.
In the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training.
Read more
The PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids.
The TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of > 10 seconds has been used to identify frailty.
Cognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills.
The prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation.
The scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty.
Patients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay.
Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).
- Conditions
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgery
- Being tested
- Intermediate/major elective surgery
- Keywords
- Frailty, Postoperative Outcomes, Major elective surgery, Surgical Frailty, Intermediate elective surgery
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate/major elective surgeryProcedure or surgery
Any intermediate/major elective surgery at Landspítali -The National University Hospital in Iceland
| Study group | Role | What they receive |
|---|---|---|
| Frailty screening cohort | The study will consist of a cohort of surgical patients ≥ 70 years undergoing Intermediate/major elective surgery who present for preoperative assessment at the anesthesia outpatient clinic at Landspitali - The National University Hospital in Iceland.
Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail). Receives: Procedure: Intermediate/major elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate and severe surgical complications (Clavien-Dindo ≥2)
Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
Measured: Time frame: From the same day after surgery to postoperative day 30.
90-day Readmission
Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. A patient´s readmission on the same day of discharge is considered a single continuous admission, unless it is clear the reason for readmission is not related to the initial admission or surgery. In which case it would be considered a separate readmission.
Measured: From the day of surgery to postoperative day 90.
Secondary outcomes (4)
Length of hospital stay
Length of the primary hospital stay after surgery, measured in days. Same-day discharge will be counted as 0, discharge on postoperative day 1 will be counted as 1, etc. A patient's readmission on the same day of discharge is considered a single continuous admission, unless the reason for readmission is clearly unrelated to the initial admission or surgery, in which case it will be considered a separate admission.
Measured: From the day of primary surgery until discharge from the index hospitalization (same-day discharge counted as 0 days), assessed up to 180 days postoperatively.
Postoperative delirium during primary hospitalization
Any mention of postoperative delirium during the primary hospitalization in nursing/physician notes will be used to identify delirium.
Measured: From the day of surgery (postoperative day 0) until first documented postoperative delirium or discharge from the index hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
Short-term mortality
Defined as the death of the patient after surgery
Measured: Up to 1 year after the primary surgery
Non-home discharge
Non-home discharge will be identified as the postoperative hospital discharge to a nursing home or a rehabilitation center. Discharge to patient hotels will not be included. In addition, non-home discharge will not include patients who live in a nursing home prior to the surgery.
Measured: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start20 Jan 2025
- Primary completion31 May 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty in Adult SurgeryStudies 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
- 350 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Landspitali University Hospital
- Responsible party
- Principal investigator, Martin Ingi Sigurdsson, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367828
- Sponsor's protocol ID
- VRN 25/2024
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
Publications
Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9.
PubMed 36307919
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT07367828
- Acronym / sponsor ID
- VRN 25/2024
- Conditions
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgery
- Keywords
- Frailty, Postoperative Outcomes, Major elective surgery, Surgical Frailty, Intermediate elective surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Landspitali University Hospital
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery.
In the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training.
The PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids.
The TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of > 10 seconds has been used to identify frailty.
Cognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills.
The prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation.
The scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty.
Patients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay.
Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frailty screening cohort | – | Procedure: Intermediate/major elective surgeryThe study will consist of a cohort of surgical patients ≥ 70 years undergoing Intermediate/major elective surgery who present for preoperative assessment at the anesthesia outpatient clinic at Landspitali - The National University Hospital in Iceland. Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study population will consist of all patients ≥70 years who present for preoperative assessment with an anesthesiologist at Landspitali before undergoing intermediate/major surgery, The National University Hospital of Iceland.
Key inclusion criteria (2 listed)
- Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.
- Patients assigned to undergo intermediate/major surgery
Key exclusion criteria (1 listed)
- Not undergoing planned surgery
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 |
|---|---|---|
| Intermediate/major elective surgeryAny intermediate/major elective surgery at Landspítali -The National University Hospital in Iceland | Procedure or surgery | Frailty screening cohort |
Primary outcome
Moderate and severe surgical complications (Clavien-Dindo ≥2)
Time frame: Time frame: From the same day after surgery to postoperative day 30.
Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
90-day Readmission
Time frame: From the day of surgery to postoperative day 90.
Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. A patient´s readmission on the same day of discharge is considered a single continuous admission, unless it is clear the reason for readmission is not related to the initial admission or surgery. In which case it would be considered a separate readmission.
4 secondary outcomes
Length of hospital stay
Time frame: From the day of primary surgery until discharge from the index hospitalization (same-day discharge counted as 0 days), assessed up to 180 days postoperatively.
Postoperative delirium during primary hospitalization
Time frame: From the day of surgery (postoperative day 0) until first documented postoperative delirium or discharge from the index hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
Short-term mortality
Time frame: Up to 1 year after the primary surgery
Non-home discharge
Time frame: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
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 26 Jan 2026.
- Background: PubMed 36307919Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9.
- Individual participant dataSharing planned: No. The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
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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.
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 in Adult Surgery and Frailty Syndrome, run by University of Iceland at 1 site in Iceland.
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 2 inclusion and 1 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 26 Jan 2026. 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 Iceland. 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 Martin I Sigurdsson, MD, PhD (+354-824-8282, mingi@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate and severe surgical complications (Clavien-Dindo ≥2) (time frame: Time frame: From the same day after surgery to postoperative day 30.). 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?
On the ClinicalTrials.gov record for NCT07367828, which also lists 1 linked publication.
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 26 Jan 2026.