Major Noncardiac SurgeryNCT07409467
Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery
An observational study of Major Noncardiac Surgery and Geriatric Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective observational study aims to develop and evaluate predictive models for postoperative complications in patients aged 65 years or older scheduled for elective major surgery. The investigators will recruit 520 eligible patients visiting the preoperative assessment clinic. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Noncardiac Surgery, Geriatric Anesthesia, Postoperative Complications
- What is being tested?
- Preoperative assessment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Feb 2026to 28 Feb 2027
- 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: Patients aged 65 years or older scheduled for elective major noncardiac surgery. Participants in this cohort will undergo a comprehensive preoperative assessments including physical activity, nutritional risk, psychological status, short physical performance battery, and bioelectrical impedance analysis at the preoperative assessment clinic.
Who may be able to join
- Patients aged 65 years or older scheduled for elective surgery who visit the preoperative assessment clinic.
- Patients scheduled for major non-cardiac surgery.
- Patients who voluntarily provide written informed consent.
Who cannot join
- Patients unable to communicate.
- Patients unable to complete questionnaires or perform physical function tests.
- Patients with implanted electronic medical devices, such as cardiac pacemakers or implantable patient monitoring devices.
- Patients whose scheduled surgery is cancelled.
- Patients with underlying medical or psychiatric conditions that may affect the study outcomes.
- Any other reason that, in the opinion of the investigator, makes the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Soohyuk Yoon, MD, +82-2-2072-2467, yoonsh3152@snu.ac.kr
About this study
Official title: Development of a Surgical Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery: A Prospective Cohort Study
This prospective observational study aims to develop and evaluate predictive models for postoperative complications in patients aged 65 years or older scheduled for elective major surgery. The investigators will recruit 520 eligible patients visiting the preoperative assessment clinic.
The study involves the prospective collection of comprehensive preoperative data using specific validated tools:
Read more
- Physical Activity: Assessed using the Saltin-Grimby Physical Activity Scale (SGPAS) to categorize physical activity intensity.
- Nutritional Risk: Screened using the Nutritional Risk Screening 2002 (NRS-2002) tool.
- Psychological Status: Evaluated for anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).
- Body Composition: Measured using a portable bioelectrical impedance analysis (BIA) device (BWA2.0S, InBody) to assess muscle mass, body fat/water, and phase angle.
- Physical Function: Assessed via the short physical performance battery (SPPB) using electronic measurement devices (AndanteFit, DYPHI) to calculate frailty index and physical age.
The primary endpoint is the occurrence and severity of postoperative complications within 30 days, evaluated using both the Clavien-Dindo Classification and the Comprehensive Complication Index (CCI). Using the collected dataset, the investigators will develop prediction models using both classical regression analysis and machine learning algorithms to compare their predictive performance.
- Being tested
- Preoperative assessment
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative assessmentOther
As this is a prospective observational study, no experimental clinical interventions or treatments are administered to the participants. Participants will undergo comprehensive preoperative assessments including physical activity, nutritional risk screening, psychological status, short physical performance battery, and bioelectrical impedance analysis.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Surgical Cohort | All patients will receive the standard of care and undergo surgical procedures as determined by their primary care team and surgeons. Receives: Other: Preoperative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
30-day postoperative complications (evaluated by Clavien-Dindo classification and the Comprehensive Complication Index)
Measured: Postoperative 30 days
Secondary outcomes (1)
Length of hospital stay
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start19 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Noncardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409467
- Sponsor's protocol ID
- PREPASS
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Surgical Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07409467
- Acronym / sponsor ID
- PREPASS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Feb 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.
This prospective observational study aims to develop and evaluate predictive models for postoperative complications in patients aged 65 years or older scheduled for elective major surgery. The investigators will recruit 520 eligible patients visiting the preoperative assessment clinic.
The study involves the prospective collection of comprehensive preoperative data using specific validated tools:
- Physical Activity: Assessed using the Saltin-Grimby Physical Activity Scale (SGPAS) to categorize physical activity intensity.
- Nutritional Risk: Screened using the Nutritional Risk Screening 2002 (NRS-2002) tool.
- Psychological Status: Evaluated for anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).
- Body Composition: Measured using a portable bioelectrical impedance analysis (BIA) device (BWA2.0S, InBody) to assess muscle mass, body fat/water, and phase angle.
- Physical Function: Assessed via the short physical performance battery (SPPB) using electronic measurement devices (AndanteFit, DYPHI) to calculate frailty index and physical age.
The primary endpoint is the occurrence and severity of postoperative complications within 30 days, evaluated using both the Clavien-Dindo Classification and the Comprehensive Complication Index (CCI). Using the collected dataset, the investigators will develop prediction models using both classical regression analysis and machine learning algorithms to compare their predictive performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Surgical Cohort | – | Other: Preoperative assessmentAll patients will receive the standard of care and undergo surgical procedures as determined by their primary care team and surgeons. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older scheduled for elective major noncardiac surgery. Participants in this cohort will undergo a comprehensive preoperative assessments including physical activity, nutritional risk, psychological status, short physical performance battery, and bioelectrical impedance analysis at the preoperative assessment clinic.
Key inclusion criteria (3 listed)
- Patients aged 65 years or older scheduled for elective surgery who visit the preoperative assessment clinic.
- Patients scheduled for major non-cardiac surgery.
- Patients who voluntarily provide written informed consent.
Key exclusion criteria (6 listed)
- Patients unable to communicate.
- Patients unable to complete questionnaires or perform physical function tests.
- Patients with implanted electronic medical devices, such as cardiac pacemakers or implantable patient monitoring devices.
- Patients whose scheduled surgery is cancelled.
- Patients with underlying medical or psychiatric conditions that may affect the study outcomes.
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 assessmentAs this is a prospective observational study, no experimental clinical interventions or treatments are administered to the participants. Participants will undergo comprehensive preoperative assessments including physical activity, nutritional risk screening, psychological status, short physical performance battery, and bioelectrical impedance analysis. | Other | Prospective Surgical Cohort |
Primary outcome
Postoperative complications
Time frame: Postoperative 30 days
30-day postoperative complications (evaluated by Clavien-Dindo classification and the Comprehensive Complication Index)
1 secondary outcome
Length of hospital stay
Time frame: Postoperative 30 days
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 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 Major Noncardiac Surgery and Geriatric Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Feb 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Postoperative 30 days). 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 13 Feb 2026.