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

NCT07165236 | Recruiting

• 1 other identifier: POCD
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

general anesthesia; postoperative cognitive complications; urinary bladder neoplasm; perioperative period; frail older adult; S100b

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

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

Secondary Outcomes (4)

• to examine changes in s100b in the perioperative period

  baseline - 2hours after surgery - 24hours after surgery

• to examine changes in NSE in the perioperative period

  baseline - 2hours after surgery- 24hours after surgery

• to examine changes in IL4 in the perioperative period

  baseline - 2hours after surgery- 24hours after surgery

• to examine changes in iIL6 in the perioperative period

  baseline - 2hours after surgery- 24hours after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

Osijek UH

Osijek, Croatia, 31000, Croatia

RECRUITING

Related Publications (7)

• Isgro MA, Bottoni P, Scatena R. Neuron-Specific Enolase as a Biomarker: Biochemical and Clinical Aspects. Adv Exp Med Biol. 2015;867:125-43. doi: 10.1007/978-94-017-7215-0_9.

  PMID: 26530364 BACKGROUND

• Arevalo-Rodriguez I, Smailagic N, Roque-Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the early detection of dementia in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2021 Jul 27;7(7):CD010783. doi: 10.1002/14651858.CD010783.pub3.

  PMID: 34313331 BACKGROUND

• Picca 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 BACKGROUND

• Carreon 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 BACKGROUND

• Cui 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 BACKGROUND

• Demir 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 BACKGROUND

• Sung 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.

  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Urinary Bladder Neoplasms; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Slavica Kvolik, MD, PhD

  KBC Osijek

  STUDY CHAIR

Central Study Contacts

Ana Cicvarić

CONTACT

+385 511 502; annikaadv@gmail.com

Slavica Kvolik, MD, PhD

CONTACT

+385 511 502; slavica.kvolik@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: September 10, 2025
• Study Start: November 28, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after study complete
• Access Criteria: within few days

Locations

CR (1)