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NCT Number: NCT07409467

Risk Prediction Model for Older Adults Undergoing Noncardiac Surgery

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Postoperative complications

    Time frame: Postoperative 30 days

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

Secondary outcomes

  1. Length of hospital stay

    Time frame: Postoperative 30 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Development of a Surgical Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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