此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients (POCDTURMSTUD)

2026年7月20日 更新者:Eylem Yaşar、Muğla Sıtkı Koçman University

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Melike Korkmaz Toker, MD
  • 电话号码:+905054747098
  • 邮箱:meltoker@gmail.com

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population consists of patients aged 65 years and older undergoing transurethral resection at Mugla Training and Research Hospital. These patients represent an elderly surgical population at risk for postoperative cognitive dysfunction and delirium. Participants are enrolled consecutively according to eligibility criteria and followed throughout the perioperative period.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of postoperative cognitive dysfunction and delirium
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Risk factors associated with POCD and delirium
大体时间: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
Performance of the predictive risk model
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Eylem Yasar, MD、Muğla Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月5日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2026年11月15日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅