POD Risk for Colorectal Cancer Surgery

NCT07597330 | Completed DMC

• 2 other identifiers: POD after CRC surgery25JRRA1256
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer (MSI-H); Postoperative Delirium (POD)

Keywords

Colorectal Cancer; Postoperative Delirium; Risk Scoring Scale; TyG Index; Clustering Subtype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative complications (intestinal fistula, bleeding, acute kidney injury, pulmonary infection, abdominal infection)

  Up to 30 days after surgery

• Length of hospital stay (LOS)

  Perioperative/Periprocedural

• In-hospital mortality

  Up to 30 days after surgery

• Medical expenses

  Up to 30 days after surgery

Study Arms (1)

Colorectal Cancer

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

The first hospital of lanzhou university

Lanzhou, Gansu, 73000, China

Location

Related Publications (2)

• 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.

  PMID: 35526000 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.

  PMID: 39470760 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Emergence Delirium

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: May 19, 2026
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)