Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery

February 8, 2026 updated by: Hojin Lee, MD, PhD, Seoul National University Hospital

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

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jongno-gu
      • Seoul, Jongno-gu, South Korea, 03080
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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)
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Postoperative 30 days
Postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PREPASS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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