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临床试验/NCT04554550
NCT04554550已完成不适用

Post-operative Cognitive Function Following Pelvic Floor Surgery

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Change in episodic memory neurocognitive test scores

研究概览

简要总结

The aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.

详细描述

Post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. However, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. The population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. Therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. The investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. Participants will be women undergoing surgery for pelvic organ prolapse. All participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. In addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse.

排除标准

  • Women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder
  • A Mini-Mental State Exam (MMSE) score of greater than 24
  • Non-english speaking
  • Any severe visual or auditory disorder
  • Alcoholism or drug dependence

结局指标

主要结局

Change in episodic memory neurocognitive test scores

时间窗: 8 weeks

Episodic memory will be assessed using the Scene Encoding/Recognition Test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Uduak Andy

Assistant Professor of Obstetrics and Gynecology

University of Pennsylvania

研究点 (1)

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