Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative assessment.
- Who it may be relevant to
- Registry conditions: Major Noncardiac Surgery, Geriatric Anesthesia, Postoperative Complications. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Surgical Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery: A Prospective Cohort Study
Overview
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.
Interventions
- Other Preoperative assessment
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.
Primary outcome measures
- Postoperative complications [Time frame: Postoperative 30 days]
Secondary outcome measures (1)
- Length of hospital stay [Time frame: Postoperative 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07409467 · PREPASS