Post-operative Cognitive Function Following Pelvic Floor Surgery
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
- 否
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
Uduak Andy
Assistant Professor of Obstetrics and Gynecology
University of Pennsylvania
