NCT04551859Unknown不适用
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinous Ligament Fixation Surgery
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 41
- 主要终点
- Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF
研究概览
简要总结
The primary objective of this study is to demonstrate the feasibility of using a Finite Element model of pelvic organs by evaluating the concordance of pelvic organ mobility measurements performed by this mechanical model compared to the observations on the post-operative pelvic MRI in patients undergoing a sacrospinofixation surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 80
- •With at least a grade II apical prolapse according to the POP-Q classification
- •Treated with a sacrospinous ligament fixation (SSF) by the vaginal route
排除标准
- •History of abdominal, pelvic, vaginal or vulvar surgery except hysterectomy
- •Association of another POP or urinary incontinence surgery (subvesical plication, levator myorrhaphy, plication of anterior rectal wall, perineorrhaphy ...)
- •MRI contraindication
- •Legal incapacity or limited legal capacity
- •Subject unlikely to cooperate with the study
结局指标
主要结局
Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF
时间窗: 6 months after surgery
Concordance of mobility measurements of the 3 points C, Ba, Bp during the defecation sequence, between the Finite Elements (FE) model and the dynamic pelvic floor MRI after sacrospinous ligament fixation (SSF)
次要结局
- Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF(6 months after surgery)
- Comparison of the pelvic organ mobility before and after surgery(6 months after surgery)
- Elasticity study of the vaginal tissue (Lille)(after surgery (day 0))
- Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF(6 months after surgery)
研究者
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