NCT07165236 Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
| NCT ID | NCT07165236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Osijek University Hospital |
| Condition | Cognitive Decline |
| Study Type | OBSERVATIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 42 participants in total. It began in 2024-11-28 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Slavica Kvolik, MD, PhD
STUDY CHAIR
KBC Osijek
Frequently Asked Questions
Who can join the NCT07165236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07165236 currently recruiting?
Yes, NCT07165236 is actively recruiting participants. Contact the research team at annikaadv@gmail.com for enrollment information.
Where is the NCT07165236 trial being conducted?
This trial is being conducted at Osijek, Croatia.
Who is sponsoring the NCT07165236 clinical trial?
NCT07165236 is sponsored by Osijek University Hospital. The principal investigator is Slavica Kvolik, MD, PhD at KBC Osijek. The trial plans to enroll 42 participants.