Clinical trial · Observational
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Association of Perioperative Cognitive Dysfunction With Circulating Biomarkers of Neurological Damage in Patients Underging Transurethral Resection of Bladder Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Testing | — | UNRESOLVED | — |
| Comorbidities | — | UNRESOLVED | — |
| Demographic Data | — | UNRESOLVED | — |
| Frail | — | UNRESOLVED | — |
| General Anesthesia | — | UNRESOLVED | — |
| Hand Grip Strength | — | UNRESOLVED | — |
| Perioperative Complications | — | UNRESOLVED | — |
| Socio-economic Status |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adult patients (>18 years) who must undergo transurethral resection of the bladder.
- description
- 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.
Primary outcomes (2)
- measure
- 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.
- timeFrame
- from baseline - 24 hours after surgery- 48 hours after surgery
- description
- 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
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
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- BACKGROUNDPicca A, Coelho-Junior HJ, Calvani R, Marzetti E, Vetrano DL. Biomarkers shared by frailty and sarcopenia in older adults: A systematic review and meta-analysis. Ageing Res Rev. 2022 Jan;73:101530. doi: 10.1016/j.arr.2021.101530. Epub 2021 Nov 25. PMID 34839041
- BACKGROUNDCarreon T, Hein MJ, Viet SM, Hanley KW, Ruder AM, Ward EM. Increased bladder cancer risk among workers exposed to o-toluidine and aniline: a reanalysis. Occup Environ Med. 2010 May;67(5):348-50. doi: 10.1136/oem.2009.051136. Epub 2009 Nov 2. PMID 19884651
- BACKGROUNDCui HW, Turney BW, Griffiths J. The Preoperative Assessment and Optimization of Patients Undergoing Major Urological Surgery. Curr Urol Rep. 2017 Jul;18(7):54. doi: 10.1007/s11934-017-0701-z. PMID 28589402
- BACKGROUNDDemir DO, Doluoglu OG, Yildiz AK, Kacan T, Yazar VM, Demirbas A, Ozgur BC. Effect of Re-TUR time on recurrence and progression in high-risk non-muscle-invasive bladder cancer. Cir Cir. 2022;90(S2):6-12. doi: 10.24875/CIRU.21000905. PMID 36480752
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.