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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium (POD); Colorectal Cancer (MSI-H)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 590

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 73000
      • The First Hospital of Lanzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Colorectal Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: LanZhou University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Postoperative Delirium; Risk Scoring Scale; TyG Index; Clustering Subtype
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Colorectal Neoplasms
• Other Study ID Numbers: POD after CRC surgery; 25JRRA1256 (Other Grant/Funding Number: Natural Science Foundation of Gansu Province)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No