- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eylem Yasar, MD
- Numéro de téléphone: +905332392622
- E-mail: eylemtarakci@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Melike Korkmaz Toker, MD
- Numéro de téléphone: +905054747098
- E-mail: meltoker@gmail.com
Lieux d'étude
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Muğla, Turquie (Türkiye), 48000
- Recrutement
- Muğla Training and Research Hospital
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Contact:
- Eylem Yasar, MD
- Numéro de téléphone: +905332392622
- E-mail: eylemtarakci@gmail.com
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Contact:
- Melike Korkmaz Toker, MD
- Numéro de téléphone: +90 505 474 7098
- E-mail: meltoker@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of postoperative cognitive dysfunction and delirium
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Risk factors associated with POCD and delirium
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Eylem Yasar, MD, Muğla Training and Research Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Les troubles mentaux
- Complications postopératoires
- Processus pathologiques
- Confusion
- Manifestations neurocomportementales
- Troubles neurocognitifs
- Troubles cognitifs
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Complications cognitives postopératoires
- Délire d'émergence
- Délire
- Dysfonctionnement cognitif
Autres numéros d'identification d'étude
- 2436 / 2424
- BAKIRCAY-2025-2424 (Autre identifiant: Izmir Bakircay University)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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