Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07409467
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.
Study:
NCT07409467
Study Brief:
Protocol Section:
NCT07409467