Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

NCT ID: NCT04837391

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-21

Study Completion Date

2021-07-21

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.

Conditions

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Postoperative Cognitive Dysfunction Postoperative Delirium Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Urologic oncology surgery in elderly

Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years

Addenbrooke Cognitive Examination III (ACE-III)

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.

Near Infrared Spectroscopy (NIRS)

Intervention Type 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.

Blood sample

Intervention Type 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.

Interventions

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Addenbrooke Cognitive Examination III (ACE-III)

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.

Intervention Type DIAGNOSTIC_TEST

Confusion Assessment Method

Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.

Intervention Type DIAGNOSTIC_TEST

Near Infrared Spectroscopy (NIRS)

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.

Intervention Type DEVICE

Blood sample

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland)

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meltem Savran Karadeniz, Assoc. Prof.

Role: STUDY_DIRECTOR

Istanbul University

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emre Şentürk, MD

Role: CONTACT

+905326114062

Facility Contacts

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Meltem Savran Karadeniz, Assoc.Prof.

Role: primary

+905334845563

References

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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.

Reference Type BACKGROUND
PMID: 30072128 (View on PubMed)

Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.

Reference Type BACKGROUND
PMID: 24622758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29100194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31485127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26106326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23899512 (View on PubMed)

Other Identifiers

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2019/1555

Identifier Type: -

Identifier Source: org_study_id

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