Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19,000
- 试验地点
- 31
- 主要终点
- Incidence of severe complications
研究概览
简要总结
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
详细描述
RATIONAL Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
MAIN OBJECTIVE Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women depending on the type of surgery performed.
SECONDARY OBJECTIVES Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery.
Compare the incidence rates of severe complications considering the type of procedure (with or without mesh, vaginal or laparoscopic, etc.), comorbidities, mesh type, surgeon experience, and surgical volume centre.
Report the health and satisfaction of operated women. Estimate the risk of revision surgery for failure or recurrence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
- •18 years old or more.
排除标准
- 未提供
结局指标
主要结局
Incidence of severe complications
时间窗: 10 years
Grade III or more according to Clavien-Dindo classification
次要结局
- Surgical recovery for failure or recurrence(10 years)
- Time lapse of occurrence of severe complications(10 years)
- Health and perceived improvement(10 years)