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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)].
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urologic oncology surgery in elderly | Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Spectroscopy (NIRS) | Device | 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over the age of 65 who are planned to undergo major urooncological surgery (radical nephrectomy, radical prostatectomy and radical cystectomy) as of April 21, 2020 at the Istanbul University Hospital are included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emre Şentürk, MD | Contact | +905326114062 | dr.emresentrk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meltem Savran Karadeniz, Assoc. Prof. | Istanbul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30072128 | Background | Yanagisawa R, Tanaka M, Yashima F, Arai T, Kohno T, Shimizu H, Fukuda K, Naganuma T, Mizutani K, Araki M, Tada N, Yamanaka F, Shirai S, Tabata M, Ueno H, Takagi K, Higashimori A, Watanabe Y, Yamamoto M, Hayashida K. Frequency and Consequences of Cognitive Impairmentin Patients Underwent Transcatheter Aortic Valve Implantation. Am J Cardiol. 2018 Sep 1;122(5):844-850. doi: 10.1016/j.amjcard.2018.05.026. Epub 2018 Jun 2. | |
| 24622758 |
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Blood samples are collected from study participants after anesthesia induction and after the end of the operation.
|
| Blood sample | Diagnostic Test | 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. |
|
| Addenbrooke Cognitive Examination III (ACE-III) | Diagnostic Test | 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. |
|
| Confusion Assessment Method | Diagnostic Test | Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium. |
|
Blood IL-6 concentration is determined by an enzyme-linked immunosorbent assay kit. |
| Change from baseline serum concentration of IL-6 at 6 hours |
| 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. |
| Background |
| Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119. |
| 29100194 | Background | Plas M, Rotteveel E, Izaks GJ, Spikman JM, van der Wal-Huisman H, van Etten B, Absalom AR, Mourits MJE, de Bock GH, van Leeuwen BL. Cognitive decline after major oncological surgery in the elderly. Eur J Cancer. 2017 Nov;86:394-402. doi: 10.1016/j.ejca.2017.09.024. Epub 2017 Nov 5. |
| 31485127 | Background | Kapoor I, Prabhakar H, Mahajan C. Postoperative Cognitive Dysfunction. Indian J Crit Care Med. 2019 Jun;23(Suppl 2):S162-S164. doi: 10.5005/jp-journals-10071-23196. |
| 26106326 | Background | Fournier A, Krause R, Winterer G, Schneider R. Biomarkers of postoperative delirium and cognitive dysfunction. Front Aging Neurosci. 2015 Jun 9;7:112. doi: 10.3389/fnagi.2015.00112. eCollection 2015. |
| 23899512 | Background | Li RL, Zhang ZZ, Peng M, Wu Y, Zhang JJ, Wang CY, Wang YL. Postoperative impairment of cognitive function in old mice: a possible role for neuroinflammation mediated by HMGB1, S100B, and RAGE. J Surg Res. 2013 Dec;185(2):815-24. doi: 10.1016/j.jss.2013.06.043. Epub 2013 Jul 17. |
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000071257 | Emergence Delirium |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
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