Development of a Surgical Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery: A Prospective Cohort Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Postoperative complications
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prospective Surgical Cohort
All patients will receive the standard of care and undergo surgical procedures as determined by their primary care team and surgeons.
干预措施: Preoperative assessment (Other)
结局指标
主要结局
Postoperative complications
时间窗: Postoperative 30 days
30-day postoperative complications (evaluated by Clavien-Dindo classification and the Comprehensive Complication Index)
次要结局
- Length of hospital stay(Postoperative 30 days)
研究者
Hojin Lee, MD, PhD
Associate Professor
Seoul National University Hospital