Clinical trial · Observational
POD Risk for Colorectal Cancer Surgery
A Novel Risk System Integrating Clustering-derived Subtype and TyG Index for Predicting Postoperative Delirium in Colorectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (MSI-H) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Postoperative Delirium (POD) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Colorectal Cancer
Primary outcomes (1)
- measure
- Incidence of Postoperative Delirium (POD) within 7 days after surgery
- timeFrame
- From postoperative day 1 to day 7 (or until hospital discharge if earlier)
- description
- 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.
Secondary outcomes (4)
- measure
- Postoperative complications (intestinal fistula, bleeding, acute kidney injury, pulmonary infection, abdominal infection)
- timeFrame
- Up to 30 days after surgery
- description
- Recorded based on clinical symptoms, laboratory tests, and imaging findings (e.g., pulmonary infection confirmed by chest CT and elevated inflammatory markers)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal cancer (colon or rectal cancer) via - preoperative or postoperative pathology; * Scheduled for elective surgical intervention (open or laparoscopic resection); * Preoperative Mini Mental State Examination (MMSE) score ≥18 (no pre-existing cognitive impairment); * Able to provide written informed consent (self or legal representative); * Complete preoperative clinical and laboratory data. Exclusion Criteria: * Postoperative pathology confirmed non-malignant tumor; * Age ≥90 years old; * Presence of visual, cognitive, language, or speech impairment; or history of neuropsychiatric diseases (dementia, Parkinson's disease, cerebrovascular accidents); * No preoperative cognitive function assessment or MMSE score \<18; * Emergency surgery or palliative surgery (non-curative resection); * Postoperative admission to intensive care unit (ICU) (excluded due to different monitoring and intervention patterns); * Missing key data \>5% (e.g., incomplete TyG index calculation, missing clustering analysis variables); * Refusal to participate or inability to complete 7-day postoperative follow-up.
References
Publications (2)
- RESULTQin 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. PMID 35526000
- RESULTLi 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. PMID 39470760