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Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

I

Istanbul University

Status

Unknown

Conditions

Frailty
Postoperative Delirium
Postoperative Cognitive Dysfunction

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04837391
2019/1555

Details and patient eligibility

About

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)].

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

48 participants in 1 patient group

Urologic oncology surgery in elderly
Description:
Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years
Treatment:
Diagnostic Test: Blood sample
Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III)
Device: Near Infrared Spectroscopy (NIRS)
Diagnostic Test: Confusion Assessment Method

Trial contacts and locations

1

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Central trial contact

Emre Şentürk, MD

Data sourced from clinicaltrials.gov

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