- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Eylem Yasar, MD
- Telefonnummer: +905332392622
- E-Mail: eylemtarakci@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Melike Korkmaz Toker, MD
- Telefonnummer: +905054747098
- E-Mail: meltoker@gmail.com
Studienorte
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Muğla, Türkei (türkiye), 48000
- Rekrutierung
- Muğla Training and Research Hospital
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Kontakt:
- Eylem Yasar, MD
- Telefonnummer: +905332392622
- E-Mail: eylemtarakci@gmail.com
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Kontakt:
- Melike Korkmaz Toker, MD
- Telefonnummer: +90 505 474 7098
- E-Mail: meltoker@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of postoperative cognitive dysfunction and delirium
Zeitfenster: Baseline (preoperative) and postoperative days 1, 2, and 3
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Risk factors associated with POCD and delirium
Zeitfenster: From baseline (preoperative) through postoperative day 3
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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
Zeitfenster: Through study completion (anticipated November 2026)
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Assessment of the predictive model for POCD and delirium using multivariable logistic regression and receiver operating characteristic (ROC) curve analysis.
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Through study completion (anticipated November 2026)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Eylem Yasar, MD, Muğla Training and Research Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Kognitionsstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Postoperative kognitive Komplikationen
- Entstehung Delirium
- Delirium
- Kognitive Dysfunktion
Andere Studien-ID-Nummern
- 2436 / 2424
- BAKIRCAY-2025-2424 (Andere Kennung: Izmir Bakircay University)
Plan für individuelle Teilnehmerdaten (IPD)
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