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

NCT ID: NCT07165236

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2029-10-01

Brief Summary

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.

Detailed Description

Bladder tumor is one of the most widespread tumors in the world, with increasing prevalence at the global level. It is the most common malignant disease of the urinary system. One of the procedures in patients with bladder tumors is transurethral resection of the bladder. This procedure is most often performed endoscopically under general anesthesia. The number of patients undergoing this type of procedure is increasing.

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 also associated with the onset of neurodegeneration and oxidative stress. For this reason, cognitive dysfunction can be expected in this patient population in addition to bladder cancer.

Another factor that affects the formation of bladder tumors is smoking. The connection between smoking and the formation of bladder tumors is the presence of carcinogenic substances in the urine of people who smoke, including aromatic amines. Likewise, cigarette smoke itself is harmful, as it also contains numerous carcinogenic substances, which are absorbed from the lungs into the bloodstream, and then reach the bladder via the kidneys. Given that urine is present in the bladder for a long time, its mucosa is exposed to these carcinogenic substances. Carcinogenic substances produced during smoking also lead to an indirect increase in risk, because they damage the immune system of people and lead to the development of inflammatory processes. Smoking is also one of the risk factors associated with the weakening of a person's cognitive status.

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. Postoperative cognitive deficit includes cognitive disorders in the postoperative period, which are associated with numerous complications, which can lead to loss of independence in patients, increased morbidity and mortality, and increase the costs of treatment. In the group of patients with a bladder tumor who will undergo transurethral resection of the bladder, no evaluation of risk factors related to perioperative cognitive deficit was performed, nor was there an examination of the perioperative cognitive deficit itself.

Considering that this is an elderly population, it is expected that some patients will already be frail before the operation with the presence of a significant degree of dementia. In them, the identification of factors for postoperative cognitive disorder is essential, with the aim of taking measures to prevent the deterioration of their impaired general health condition. The concept of clinical frailty is becoming more and more important and relevant when providing healthcare services and healthcare to patients.

Clinical frailty was introduced almost three decades ago as a term in the medical literature, a benchmark for assessing the complex health condition of the elderly and patients with numerous comorbidities. The use of the clinical frailty scale as a tool in clinical practice provides information on the adequate direction of care for patients and information on the further development of health care and health policy. The scale can also help health care providers provide information to patients' families and patients themselves about the risks and benefits of procedures related to the treatment of patients.

Recognition of risk factors and their evaluation are a significant part of perioperative care for patients undergoing surgery under general anesthesia. Risk identification can lead to targeted and directed medical procedures that can be intervened in a timely manner, and reduce the unfavorable clinical outcomes observed after surgical treatment of bladder tumors. Some of these interventions are the recognition and treatment of inflammation, the recognition and correction of anemia, the recognition of clinical frailty, and the implementation of prehabilitation measures in patients undergoing bladder surgery under general anesthesia. Along with them, physical therapy measures could be useful in patients with recognized signs of clinical frailty.

A 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 test is important for assessing overall upper body strength. Research has shown that hand grip strength is related to important health indicators that include mobility, the overall strength of the person undergoing the hand grip test, the person's cognitive functions, the bone density of the person being tested, but hand grip strength is also related to possible disorders of the cardiovascular system. Improving hand grip strength using strength exercises can help maintain functional independence, especially in older and frail adults. The hand grip test itself is very simple, and in addition, it is also an inexpensive way to assess the overall strength of the upper body, and therefore to detect possible health problems. Monitoring the strength of the hand grip over time can provide valuable insight into the physical abilities of the examined person, and warn of possible disorders that may arise.

In addition to the previously mentioned clinical indicators, laboratory indicators play a significant role in the evaluation of the preoperative condition of the patient and the monitoring of postoperative dynamics. Organ function is regularly assessed in patients by measuring indicators specific to kidney or liver function, such as urea, creatinine, coagulation status, albumin or transaminases.

These indicators could be correlated with clinical frailty and cognitive status. The mini mental state examination test (MMSE) and the cognitive assessment test MoCa (Montreal Cognitive assessment) are the most frequently used methods in the detection of cognitive impairment in clinical and research fields. They are intended as an aid in the clinical examination of the cognitive part of the mental state and are used as instruments for screening for cognitive impairment and monitoring the patient's condition over time. The MMSE is a mental state assessment test, intended as an aid in the clinical evaluation of the cognitive part of the mental state. This test is one of the most commonly used short instruments for screening for cognitive impairment and monitoring the patient's condition over time. The highest number of points on the test is thirty, if a person has less than twenty-four points it is defined as suspected dementia. The MoCa test was originally developed to detect mild cognitive impairment, but it is also used as a screening test for dementia. The total possible test score is thirty points, and a score of twenty-six points or more is considered normal. The MoCA encompasses several different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional abilities, conceptual thinking, calculation and orientation. The time of application of the MoCA test itself is approximately 10 minutes.

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 operations under general anesthesia.

Conditions

Cognitive Decline; Urinary Bladder Cancer; Frail; Biomarker; General Anesthesia; Hand Grip Strength; Cognitive Testing; Comorbidities; Demographic Data; Socio-economic Status; Perioperative Complications

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients (>18 years) who must undergo transurethral resection of the bladder.

Program operated patients of both sexes would be included. Patients under the age of 18, patients who are unaware, those who cannot give consent for the research, and those who cannot understand the study protocol will be excluded from the study. Patients with proven hypersensitivity to some of the drugs used in the study will also be excluded. Emergency patients, people in a state of shock, septic or severely hemorrhaging patients, and people with previously known neurodevelopmental deficits will not be included in the study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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,
• patients who are unable to write
• emergency surgery,
• patients with proven hypersensitivity to some of the drugs used in the study
• patients in a state of shock, septic, or hemorrhagic patients with neurodevelopmental disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osijek University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Slavica Kvolik, MD, PhD

Role: STUDY_CHAIR

KBC Osijek

Locations

Osijek UH

Osijek, Croatia, Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Ana Cicvarić

Role: CONTACT

annikaadv@gmail.com

+385 511 502

Slavica Kvolik, MD, PhD

Role: CONTACT

slavica.kvolik@gmail.com

+385 511 502

Facility Contacts

Ana Cicvarić, M.D.

Role: primary

annikaa.dv@gmail.com

+385 31 511 511

Slavica Kvolik, M.D., PhD

Role: backup

slavica.kvolik@gmail.com

+385 31 511 511

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Reference Type: BACKGROUND

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Other Identifiers

POCD

Identifier Type: -

Identifier Source: org_study_id