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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eylem Yasar, MD
- Número de teléfono: +905332392622
- Correo electrónico: eylemtarakci@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Melike Korkmaz Toker, MD
- Número de teléfono: +905054747098
- Correo electrónico: meltoker@gmail.com
Ubicaciones de estudio
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Muğla, Turquía (Türkiye), 48000
- Reclutamiento
- Muğla Training and Research Hospital
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Contacto:
- Eylem Yasar, MD
- Número de teléfono: +905332392622
- Correo electrónico: eylemtarakci@gmail.com
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Contacto:
- Melike Korkmaz Toker, MD
- Número de teléfono: +90 505 474 7098
- Correo electrónico: meltoker@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of postoperative cognitive dysfunction and delirium
Periodo de tiempo: 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.
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Baseline (preoperative) and postoperative days 1, 2, and 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Risk factors associated with POCD and delirium
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eylem Yasar, MD, Muğla Training and Research Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Trastornos cognitivos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Complicaciones cognitivas posoperatorias
- Delirio de emergencia
- Delirio
- Disfunción congnitiva
Otros números de identificación del estudio
- 2436 / 2424
- BAKIRCAY-2025-2424 (Otro identificador: Izmir Bakircay University)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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