Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

Study Overview
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Brief Summary
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Postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. Postoperative cognitive complications are also quite common in extensive oncological surgeries. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers [S100 β, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)].

Detailed Description
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The incidence of POCD changes by age group, type of surgery, testing neuropsychological tests, timing of tests, and the method used for diagnosis. In non-cardiac surgery over the age of 60; the incidence of POCD was 26% in the postoperative 1st week and 10% in the postoperative 3rd month. Although old age is an important risk factor, POCD incidence of up to 36.6% has been reported in a younger period. Major cancer surgery is an important risk factor for development of POCD. Numerous biomarkers such as; S100β, NSE, Human IL-6, HMGB-1 protein; have been evaluated in studies to determine the diagnosis, prognosis, stage and treatment of POCD. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers. (S100β, NSE, Human IL-6 and HMGB-1 protein).The hypothesis of our study is that postoperative brain injury and inflammatory markers (S100β, NSE, Human IL-6 and HMGB-1 protein) will be higher in patients who develop POCD compared to patients who do not develop POCD in geriatric urologic oncology surgery.

Official Title
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Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients

Conditions
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Postoperative Cognitive Dysfunction, Postoperative Delirium, Frailty

Intervention / Treatment
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* Device: Near Infrared Spectroscopy (NIRS)
* Diagnostic Test: Blood sample
* Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III)
* Diagnostic Test: Confusion Assessment Method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 65 who are planned to undergo major urooncological surgery. Exclusion Criteria: Patients who refuse to participate in the study. Patients with severe hearing-vision problems. Patients with serious neurological-psychiatric disorders. Patients with language barrier. Patients with missing in any interventions. Patients with blood samples that are not suitable for the ELISA.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urologic oncology surgery in elderly<br>Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years | Device: Near Infrared Spectroscopy (NIRS)<br>* Patients are monitored by near infrared spectroscopy before anesthesia induction until end of the operation. Graphical presentation of cerebral oxygenation during surgery evaluated by INVOS Analytics Tool Version 1.2.<br>* Other names: INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland);Diagnostic Test: Blood sample<br>* Blood samples are obtained before and after surgery. S-100, Neuron specific enolase (NSE), Interleukin-6 (IL-6), High Mobility Group Box Protein (HMGB-1) are going to be studied by ELISA method after data collection process end.<br>Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III)<br>* ACE-III is administered to study participants one day before surgery, 1 week after surgery, and three months after surgery to diagnose postoperative cognitive dysfunction.<br>Diagnostic Test: Confusion Assessment Method<br>* Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addenbrooke cognitive examination at the day before surgery. | Test score is between 0-100. 100 is the best point and 0 is the worst point in the test. The test has five cognitive domains including attention, memory, language, visuospatial function, and verbal fluency. Patients who score less than 88 in preoperative tests will be diagnosed with mild cognitive impairment. | The day before surgery. | 
| Addenbrooke cognitive examination at seventh day after surgery. | POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores. | The seventh day after surgery. | 
| Addenbrooke cognitive examination at third months after surgery. | POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores. | The third months after surgery. | 
| S 100β (pg/mL) | Blood S 100β concentration is determined by an enzyme-linked immunosorbent assay kit. | Change from baseline serum concentration of S 100 β at 6 hours | 
| High Mobility Group Box1 Protein (HMGB1) (ng/mL) | HMGB1 concentration is determined by an enzyme-linked immunosorbent assay kit. | Change from baseline serum concentration of HMGB1 at 6 hours | 
| Human Neuron Specific Enolase (h-NSE) (ng/mL) | h-NSE concentration is determined by an enzyme-linked immunosorbent assay kit. | Change from baseline serum concentration of h-NSE at 6 hours | 
| Interleukine-6 (IL-6) (pg/mL) | Blood IL-6 concentration is determined by an enzyme-linked immunosorbent assay kit. | Change from baseline serum concentration of IL-6 at 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium is diagnosed by confusion assessment method. | Up to postoperative day one | 
| Cerebral oxygenation | Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery. | During surgery | 
| Overall postoperative complications | Stroke, transient ischemic attack, arrhythmia, heart failure, myocardial injury, respiratory failure, pneumonia, ileus, acute kidney injury, prolonged length of stay, mortality. | Up to postoperative three months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSE, postoperative cognitive dysfunction, frailty, S 100β, IL-6, HMGB-1 protein, NIRS, geriatric anesthesia