- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07719712
Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients (POCDTURMSTUD)
Prediction of Postoperative Cognitive Dysfunction and Delirium: A Prospective Observational Study to Develop a Risk Score in Elderly Patients Undergoing Transurethral Resection
Elderly patients undergoing transurethral resection are at increased risk of postoperative cognitive dysfunction (POCD) and delirium, which are associated with prolonged hospital stay, increased morbidity, and decreased quality of life. Identifying patients who are more likely to develop postoperative cognitive dysfunction or delirium remains a practical challenge in daily clinical practice. Better recognition of these patients may help tailor perioperative care and improve outcomes.
This prospective observational study aims to identify perioperative factors associated with POCD and delirium in elderly patients undergoing transurethral resection and to develop a clinically applicable risk prediction model. Cognitive function and delirium are assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
Cognitive function and delirium will be evaluated using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
The results of this study may support clinicians in recognizing vulnerable patients earlier and may contribute to more individualized perioperative management.
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative cognitive dysfunction (POCD) and delirium are frequently encountered in elderly patients after surgery and are linked to unfavorable clinical outcomes. Transurethral resection procedures, which are commonly performed in this age group, may further increase this risk due to both patient-related and perioperative factors.
In this prospective observational cohort, patients aged 65 years and older undergoing transurethral resection at Mugla Training and Research Hospital are followed to determine the incidence of POCD and delirium and to identify perioperative factors associated with their development.
Before surgery, demographic characteristics, comorbidities, frailty status, and baseline cognitive function are recorded. Baseline cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). During surgery, the anesthesia technique, procedure duration, intraoperative hemodynamic changes, and perioperative events are recorded.
After surgery, cognitive function and delirium are assessed at predefined intervals using MoCA and the Confusion Assessment Method (CAM).
The primary objective is to identify factors independently associated with POCD and delirium. In addition, a prediction model is developed using multivariable logistic regression, and its performance is evaluated by receiver operating characteristic (ROC) analysis.
The results may help to better recognize patients at higher risk and support more tailored perioperative management strategies in elderly surgical populations.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eylem Yasar, MD
- Phone Number: +905332392622
- Email: eylemtarakci@gmail.com
Study Contact Backup
- Name: Melike Korkmaz Toker, MD
- Phone Number: +905054747098
- Email: meltoker@gmail.com
Study Locations
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-
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Muğla, Turkey (Türkiye), 48000
- Recruiting
- Muğla Training and Research Hospital
-
Contact:
- Eylem Yasar, MD
- Phone Number: +905332392622
- Email: eylemtarakci@gmail.com
-
Contact:
- Melike Korkmaz Toker, MD
- Phone Number: +90 505 474 7098
- Email: meltoker@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥65 years
- Scheduled for transurethral resection procedure
- ASA physical status I-III
- Able to provide informed consent
- Adequate cognitive function to complete preoperative assessment
Exclusion Criteria:
- Pre-existing diagnosis of dementia or severe cognitive impairment (MoCA <18)
- Severe visual or hearing impairment preventing cognitive assessment
- History of psychiatric disease requiring antipsychotic or sedative medication
- Neurological disorders associated with increased delirium risk (e.g., Parkinson's disease, epilepsy)
- Inability to complete study assessments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative cognitive dysfunction and delirium
Time Frame: Baseline (preoperative) and postoperative days 1, 2, and 3
|
Postoperative cognitive dysfunction and delirium assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
POCD is defined as a decline in MoCA score compared with baseline, and delirium is identified based on CAM criteria.
|
Baseline (preoperative) and postoperative days 1, 2, and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors associated with POCD and delirium
Time Frame: From baseline (preoperative) through postoperative day 3
|
Evaluation of perioperative variables (demographic characteristics, comorbidities, frailty status, anesthesia type, and intraoperative parameters) associated with the development of POCD and delirium. Evaluation of perioperative variables (demographic characteristics, comorbidities, frailty status, anesthesia type, and intraoperative parameters) associated with the development of POCD and delirium. |
From baseline (preoperative) through postoperative day 3
|
|
Performance of the predictive risk model
Time Frame: Through study completion (anticipated November 2026)
|
Assessment of the predictive model for POCD and delirium using multivariable logistic regression and receiver operating characteristic (ROC) curve analysis.
|
Through study completion (anticipated November 2026)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eylem Yasar, MD, Muğla Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Postoperative Cognitive Complications
- Emergence Delirium
- Delirium
- Cognitive Dysfunction
Other Study ID Numbers
- 2436 / 2424
- BAKIRCAY-2025-2424 (Other Identifier: Izmir Bakircay University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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