NCT04837391

Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Frailty

Interventions

Type	Name	Description
DEVICE	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Confusion Assessment Method	Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.

Timeline

• Start date: 2020-04-21
• Primary completion: 2021-05-21
• Completion: 2021-07-21
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: Turkey (Türkiye)