Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery

NCT07409467 | Not Yet Recruiting

• 1 other identifier: PREPASS
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Noncardiac Surgery; Geriatric Anesthesia; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  30-day postoperative complications (evaluated by Clavien-Dindo classification and the Comprehensive Complication Index)

  Postoperative 30 days

Secondary Outcomes (1)

• Length of hospital stay

  Postoperative 30 days

Study Arms (1)

Prospective Surgical Cohort

All patients will receive the standard of care and undergo surgical procedures as determined by their primary care team and surgeons.

Other: Preoperative assessment

Interventions

Preoperative assessment OTHER

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.

Prospective Surgical Cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

KR (1)