- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409467
Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery
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:
- 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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Jongno-gu
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Seoul, Jongno-gu, South Korea, 03080
- Seoul National University Hospital
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Contact:
- Soohyuk Yoon, MD
- Phone Number: +82-2-2072-2467
- Email: yoonsh3152@snu.ac.kr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prospective Surgical Cohort
All patients will receive the standard of care and undergo surgical procedures as determined by their primary care team and surgeons.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: Postoperative 30 days
|
30-day postoperative complications (evaluated by Clavien-Dindo classification and the Comprehensive Complication Index)
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Postoperative 30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital stay
Time Frame: Postoperative 30 days
|
Postoperative 30 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREPASS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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