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| ID | Type | Description | Link |
|---|---|---|---|
| 25JRRA1256 | Other Grant/Funding Number | Natural Science Foundation of Gansu Province |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Delirium (POD) within 7 days after surgery | 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. | From postoperative day 1 to day 7 (or until hospital discharge if earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications (intestinal fistula, bleeding, acute kidney injury, pulmonary infection, abdominal infection) | Recorded based on clinical symptoms, laboratory tests, and imaging findings (e.g., pulmonary infection confirmed by chest CT and elevated inflammatory markers) | Up to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be selected from patients who present to the First Hospital of Lanzhou University, and are scheduled for elective surgical resection of histologically confirmed colorectal cancer**. Eligible participants will be consecutively recruited during the study period, with selection strictly adhering to predefined inclusion and exclusion criteria to ensure homogeneity and relevance to the research objective of developing a colorectal cancer-specific postoperative delirium risk prediction tool.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of lanzhou university | Lanzhou | Gansu | 73000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35526000 | Result | Qin Y, Kernan KF, Fan Z, Park HJ, Kim S, Canna SW, Kellum JA, Berg RA, Wessel D, Pollack MM, Meert K, Hall M, Newth C, Lin JC, Doctor A, Shanley T, Cornell T, Harrison RE, Zuppa AF, Banks R, Reeder RW, Holubkov R, Notterman DA, Michael Dean J, Carcillo JA. Machine learning derivation of four computable 24-h pediatric sepsis phenotypes to facilitate enrollment in early personalized anti-inflammatory clinical trials. Crit Care. 2022 May 7;26(1):128. doi: 10.1186/s13054-022-03977-3. | |
| 39470760 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Length of hospital stay (LOS) |
Total number of days of hospitalization after surgery. |
| Perioperative/Periprocedural |
| In-hospital mortality | Death occurring during the hospital stay after surgery. | Up to 30 days after surgery |
| Medical expenses | Total medical costs during the hospitalization period (including surgery, medication, examination, and nursing fees) | Up to 30 days after surgery |
| Result |
| Li H, Liu C, Yang Y, Wu QP, Xu JM, Wang DF, Sun JJ, Mao MM, Lou JS, Liu YH, Cao JB, Duan CY, Mi WD. Effect of Intraoperative Midazolam on Postoperative Delirium in Older Surgical Patients: A Prospective, Multicenter Cohort Study. Anesthesiology. 2025 Feb 1;142(2):268-277. doi: 10.1097/ALN.0000000000005276. Epub 2024 Oct 29. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |