The first hospital of lanzhou university
Lanzhou, Gansu, 73000, China
NCT Number: NCT07597330
Postoperative delirium is a common complication after colorectal cancer surgery that hinders recovery. This observational study hypothesizes that a simple, practical risk tool can be developed by combining preoperative clinical conditions, blood tests (including the TyG index), and clinical subtypes identified via clustering analysis. Investigators will enroll patients undergoing elective colorectal cancer surgery, assess delirium twice daily for 7 days postoperatively using the 3D-CAM, and finalize the scoring scale. It will help doctors quickly identify high-risk patients for targeted care to improve recovery. Only data will be collected; patients receive standard clinical treatment.
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Notify Me18 year–89 year
All sexes
Observational
Lanzhou, Gansu, 73000, China
This observational study aims to address the unmet clinical need for a simple, colorectal cancer-specific tool to predict postoperative delirium (POD), a prevalent complication linked to prolonged hospitalization and compromised recovery.
Eligible patients will undergo preoperative data collection, including demographic details, comorbidities, and laboratory tests (e.g., triglycerides, glucose for TyG index calculation, inflammatory and metabolic markers). Unsupervised K-means clustering will be applied to these multidimensional data to identify latent clinical subtypes, capturing complex interactions between metabolic status, inflammatory responses, and clinical characteristics that may influence POD risk.
Postoperatively, standardized POD assessment will be conducted twice daily for 7 days using the validated 3D-CAM tool, ensuring consistent identification of POD cases. No experimental interventions will be implemented-all participants receive routine preoperative evaluation, surgical care, and postoperative management per clinical guidelines.
Statistical analyses will first screen independent POD predictors via univariate and multivariate logistic regression. A scoring scale will then be developed by assigning weights to core predictors (clustering-derived subtypes, TyG index, and key clinical factors) based on their predictive strength (odds ratios). The scale's performance will be validated for discriminative ability (AUC) and calibration to ensure reliability in clinical practice.
The study's primary output is a user-friendly risk scoring tool that enables clinicians to rapidly assess POD risk preoperatively, facilitating targeted preventive strategies and improving patient outcomes without adding complexity to clinical workflows.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From postoperative day 1 to day 7 (or until hospital discharge if earlier)
POD is diagnosed using the 3-min Diagnostic Interview for Confusion Assessment Method (3D-CAM), a validated tool for bedside assessment. Assessments are performed twice daily by centrally trained researchers. POD is defined as a positive 3D-CAM result at any assessment during the 7-day period.
Time frame: Up to 30 days after surgery
Recorded based on clinical symptoms, laboratory tests, and imaging findings (e.g., pulmonary infection confirmed by chest CT and elevated inflammatory markers)
Time frame: Perioperative/Periprocedural
Total number of days of hospitalization after surgery.
Time frame: Up to 30 days after surgery
Death occurring during the hospital stay after surgery.
Time frame: Up to 30 days after surgery
Total medical costs during the hospitalization period (including surgery, medication, examination, and nursing fees)
LanZhou University
Other
A Novel Risk System Integrating Clustering-derived Subtype and TyG Index for Predicting Postoperative Delirium in Colorectal Cancer Patients
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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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