- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07719712
Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients (POCDTURMSTUD)
Prediction of Postoperative Cognitive Dysfunction and Delirium: A Prospective Observational Study to Develop a Risk Score in Elderly Patients Undergoing Transurethral Resection
Elderly patients undergoing transurethral resection are at increased risk of postoperative cognitive dysfunction (POCD) and delirium, which are associated with prolonged hospital stay, increased morbidity, and decreased quality of life. Identifying patients who are more likely to develop postoperative cognitive dysfunction or delirium remains a practical challenge in daily clinical practice. Better recognition of these patients may help tailor perioperative care and improve outcomes.
This prospective observational study aims to identify perioperative factors associated with POCD and delirium in elderly patients undergoing transurethral resection and to develop a clinically applicable risk prediction model. Cognitive function and delirium are assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
Cognitive function and delirium will be evaluated using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
The results of this study may support clinicians in recognizing vulnerable patients earlier and may contribute to more individualized perioperative management.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Postoperative cognitive dysfunction (POCD) and delirium are frequently encountered in elderly patients after surgery and are linked to unfavorable clinical outcomes. Transurethral resection procedures, which are commonly performed in this age group, may further increase this risk due to both patient-related and perioperative factors.
In this prospective observational cohort, patients aged 65 years and older undergoing transurethral resection at Mugla Training and Research Hospital are followed to determine the incidence of POCD and delirium and to identify perioperative factors associated with their development.
Before surgery, demographic characteristics, comorbidities, frailty status, and baseline cognitive function are recorded. Baseline cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). During surgery, the anesthesia technique, procedure duration, intraoperative hemodynamic changes, and perioperative events are recorded.
After surgery, cognitive function and delirium are assessed at predefined intervals using MoCA and the Confusion Assessment Method (CAM).
The primary objective is to identify factors independently associated with POCD and delirium. In addition, a prediction model is developed using multivariable logistic regression, and its performance is evaluated by receiver operating characteristic (ROC) analysis.
The results may help to better recognize patients at higher risk and support more tailored perioperative management strategies in elderly surgical populations.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Eylem Yasar, MD
- Telefonnummer: +905332392622
- E-post: eylemtarakci@gmail.com
Studer Kontakt Backup
- Navn: Melike Korkmaz Toker, MD
- Telefonnummer: +905054747098
- E-post: meltoker@gmail.com
Studiesteder
-
-
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Muğla, Tyrkia (Türkiye), 48000
- Rekruttering
- Muğla Training and Research Hospital
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Ta kontakt med:
- Eylem Yasar, MD
- Telefonnummer: +905332392622
- E-post: eylemtarakci@gmail.com
-
Ta kontakt med:
- Melike Korkmaz Toker, MD
- Telefonnummer: +90 505 474 7098
- E-post: meltoker@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age ≥65 years
- Scheduled for transurethral resection procedure
- ASA physical status I-III
- Able to provide informed consent
- Adequate cognitive function to complete preoperative assessment
Exclusion Criteria:
- Pre-existing diagnosis of dementia or severe cognitive impairment (MoCA <18)
- Severe visual or hearing impairment preventing cognitive assessment
- History of psychiatric disease requiring antipsychotic or sedative medication
- Neurological disorders associated with increased delirium risk (e.g., Parkinson's disease, epilepsy)
- Inability to complete study assessments
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of postoperative cognitive dysfunction and delirium
Tidsramme: Baseline (preoperative) and postoperative days 1, 2, and 3
|
Postoperative cognitive dysfunction and delirium assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).
POCD is defined as a decline in MoCA score compared with baseline, and delirium is identified based on CAM criteria.
|
Baseline (preoperative) and postoperative days 1, 2, and 3
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors associated with POCD and delirium
Tidsramme: From baseline (preoperative) through postoperative day 3
|
Evaluation of perioperative variables (demographic characteristics, comorbidities, frailty status, anesthesia type, and intraoperative parameters) associated with the development of POCD and delirium. Evaluation of perioperative variables (demographic characteristics, comorbidities, frailty status, anesthesia type, and intraoperative parameters) associated with the development of POCD and delirium. |
From baseline (preoperative) through postoperative day 3
|
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Performance of the predictive risk model
Tidsramme: Through study completion (anticipated November 2026)
|
Assessment of the predictive model for POCD and delirium using multivariable logistic regression and receiver operating characteristic (ROC) curve analysis.
|
Through study completion (anticipated November 2026)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Eylem Yasar, MD, Muğla Training and Research Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Kognisjonsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Postoperative kognitive komplikasjoner
- Emergence Delirium
- Delirium
- Kognitiv dysfunksjon
Andre studie-ID-numre
- 2436 / 2424
- BAKIRCAY-2025-2424 (Annen identifikator: Izmir Bakircay University)
Plan for individuelle deltakerdata (IPD)
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