Colorectal Cancer (MSI-H)NCT07597330
POD Risk for Colorectal Cancer Surgery
An observational study of Colorectal Cancer (MSI-H) and Postoperative Delirium (POD), run by LanZhou University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colorectal Cancer (MSI-H), Postoperative Delirium (POD)
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Colorectal Cancer, Postoperative Delirium, Risk Scoring Scale, TyG Index, Clustering Subtype
- Medical subject headings
- Colorectal Neoplasms, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Recorded based on clinical symptoms, laboratory tests, and imaging findings (e.g., pulmonary infection confirmed by chest CT and elevated inflammatory markers)
Measured: Up to 30 days after surgery
Length of hospital stay (LOS)
Total number of days of hospitalization after surgery.
Measured: Perioperative/Periprocedural
In-hospital mortality
Death occurring during the hospital stay after surgery.
Measured: Up to 30 days after surgery
Medical expenses
Total medical costs during the hospitalization period (including surgery, medication, examination, and nursing fees)
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhu Ma, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597330
- Sponsor's protocol ID
- POD after CRC surgery
- Other IDs
- 25JRRA1256
- Status last verified
- May 2026
- First submitted
- 13 Jan 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35526000Li 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.
PubMed 39470760
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Risk System Integrating Clustering-derived Subtype and TyG Index for Predicting Postoperative Delirium in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT07597330
- Acronym / sponsor ID
- POD after CRC surgery
- Keywords
- Colorectal Cancer, Postoperative Delirium, Risk Scoring Scale, TyG Index, Clustering Subtype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Delirium (POD) within 7 days after surgery
Time frame: 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.
4 secondary outcomes
Postoperative complications (intestinal fistula, bleeding, acute kidney injury, pulmonary infection, abdominal infection)
Time frame: Up to 30 days after surgery
Length of hospital stay (LOS)
Time frame: Perioperative/Periprocedural
In-hospital mortality
Time frame: Up to 30 days after surgery
Medical expenses
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 35526000Qin 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.
- Results publication: PubMed 39470760Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (MSI-H) and Postoperative Delirium (POD), run by LanZhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (POD) within 7 days after surgery (time frame: From postoperative day 1 to day 7 (or until hospital discharge if earlier)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07597330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.