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临床试验/NCT01852422
NCT01852422已完成不适用

Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse

Pop Medical Solutions1 个研究点 分布在 1 个国家开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
试验地点
1
主要终点
Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging

研究概览

简要总结

Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.

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
21 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age 21-80 years old
  • Stage III or higher pelvic prolapse

排除标准

  • Prior pelvic surgery

结局指标

主要结局

Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging

时间窗: Real time during procedure

次要结局

未报告次要终点

研究者

发起方
Pop Medical Solutions
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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