Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorOsijek University Hospital

About this trial

Bladder tumor is one of the most widespread tumors in the world, with increasing prevalence at the global level. One of the procedures in patients with bladder tumors is transurethral resection of the bladder (TURM) most often performed endoscopically under general anesthesia. This patient population has certain characteristics in common. One of them is exposure to common risk factors for the formation of bladder tumors, such as aniline dyes and solvents. These substances are associated with the onset of neurodegeneration and oxidative stress. Smoking is another factor that affects the formation of bladder tumor. A significant part of patients with bladder tumor are an elderly population, which is repeatedly exposed to surgical procedures, with numerous comorbidities, with a high risk of postoperative complications and the development of perioperative cognitive deficits, which can further complicate the postoperative course and further treatment. In the group of patients with a bladder tumor who will undergo TURM, no evaluation of risk factors related to perioperative cognitive deficit was performed, nor was there an examination of the perioperative cognitive deficit itself. In them, the identification of factors for postoperative cognitive disorder is essential. The concept of clinical frailty is becoming more important and relevant when providing healthcare services to patients. The use of the clinical frailty scale as a tool in clinical practice provides information on the adequate direction of care for patients. Decrease in muscle strength can lead to limitations in the functioning of a certain individuals. In recent years muscle strength has come to be a very important component of health, regardless of a person's age and clinical condition.The hand grip test is a test used to measure the maximum isometric strength of the hand and forearm muscles. The MMSE test and MoCA are the most frequently used methods in the detection of cognitive impairment in clinical and research fields. In addition to laboratory indicators of organic function, circulating indicators of neuroinflammation, like S100B and neuron-specific enolase, will be correlated with the patient's cognitive status.So far, no research has been conducted on the dynamics of indicators of organic function, circulating indicators of neuroinflammation, perioperative cognitive changes and clinical fraility in patients undergoing bladder tumor operation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients from 18-80 years,

elective operations of tumor bladder cancer (TUR),

patients can communicate,

patients who can sign the information consent and questionnaires

Disqualifiers

patients under the age of 18,

patients above 80 years,

patients who are unable to communicate

patients who do not understand informed consent for the research,

Trial population

Adult patients, older than 18 years, of both sex, patients that have tumor bladder cancer.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

42 Participants
are grouped into 1 trial group
Group A: Adult patients (>18 years) who must undergo transurethral resection of the bladder.

Trial outcomes

Primary outcomes

1

to examine whether the current cognitive state as measured by the Mini-Mental State Examination (MMSE) changes after the patient is exposed to surgery and general anesthesia.

Scores are generally interpreted as follows: 25-30: Normal result; 20-25: Mild cognitive impairment; 10-20: Moderate cognitive impairment; 0-10: Severe cognitive impairment. Cognitive test MMSE would be done after before surgery, 24 hours after surgery and 48 hours after surgery

Time frame
from baseline - 24 hours after surgery- 48 hours after surgery
2

To examine whether the current cognitive state, as measured using the Montreal Cognitive Assessment (MoCA), changes after the patient is exposed to surgery and general anesthesia.

The total possible score is 30 points; a score of 26 or above is considered normal. Cognitive test would be done before surgery, 24 hours after surgery, 48 hours after surgery.

Time frame
from baseline - 24 hours after surgery- 48 hours after surgery

Secondary outcomes

1

to examine changes in s100b in the perioperative period

examine chages in s100b preoperatively, 2 hours after surgery, 24 hours after surgery

Time frame
baseline - 2hours after surgery - 24hours after surgery
2

to examine changes in NSE in the perioperative period

examine changes in NSE preoperatively, 2hours after surgery, 24 hours after surgery

Time frame
baseline - 2hours after surgery- 24hours after surgery
3

to examine changes in IL4 in the perioperative period

examine changes in IL4 preoperatively, 2hours after surgery, 24 hours after surgery

Time frame
baseline - 2hours after surgery- 24hours after surgery
4

to examine changes in iIL6 in the perioperative period

examine changes in IL 6 preoperatively, 2hours after surgery, 24 hours after surgery

Time frame
baseline - 2hours after surgery- 24hours after surgery

Other outcomes

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