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POD Risk for Colorectal Cancer Surgery

15. maj 2026 opdateret af: Yuhu Ma, LanZhou University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

590

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Kolorektal cancer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Delirium (POD) within 7 days after surgery
Tidsramme: 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.
From postoperative day 1 to day 7 (or until hospital discharge if earlier)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative complications (intestinal fistula, bleeding, acute kidney injury, pulmonary infection, abdominal infection)
Tidsramme: 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)
Up to 30 days after surgery
Length of hospital stay (LOS)
Tidsramme: Perioperative/Periprocedural
Total number of days of hospitalization after surgery.
Perioperative/Periprocedural
In-hospital mortality
Tidsramme: Up to 30 days after surgery
Death occurring during the hospital stay after surgery.
Up to 30 days after surgery
Medical expenses
Tidsramme: Up to 30 days after surgery
Total medical costs during the hospitalization period (including surgery, medication, examination, and nursing fees)
Up to 30 days after surgery

Samarbejdspartnere og efterforskere

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Sponsor

LanZhou University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Faktiske)

1. juni 2025

Studieafslutning (Faktiske)

1. september 2025

Datoer for studieregistrering

Først indsendt

13. januar 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • POD after CRC surgery
  • 25JRRA1256 (Andet bevillings-/finansieringsnummer: Natural Science Foundation of Gansu Province)

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Kliniske forsøg med Postoperativt delirium (POD)

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