Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Recurrence rate of central pelvic organ prolapse
研究概览
简要总结
This study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.
详细描述
There is a lack of data in the literature comparing sacroplexing with the use of mesh with sacroplexing performed without the use of mesh in terms of recurrence, improvement in symptoms, and restoration of normal pelvic organ prolapse relationships. The objective of this study is to determine the rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the POP-Q classification who underwent laparoscopic sacroplasty with mesh (group 1) and without mesh (group 2). The study may provide information on the impact of mesh in laparoscopic surgery for the correction of central pelvic organ prolapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years
- •Clinical diagnosis of genital prolapse stage ≥ 2 according to POP-Q classification
- •Surgical treatment of laparoscopic sacropexy by mesh (group 1) and without (group 2) in female patients
- •Acquisition of informed consent
- •At least one follow-up evaluation at 24 months
排除标准
- •Age > 80 years
- •Previous genital prolapse surgery
结局指标
主要结局
Recurrence rate of central pelvic organ prolapse
时间窗: 24 months after surgery
The rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the POP-Q classification, undergoing sacroplasty with and without mesh
次要结局
- Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy(24 months after surgery)
- Rate of intraoperative and postoperative complications(During surgery and within 30 days)
- Modification of symptoms after surgery(Before surgery and 24 months after surgery)
- Changes in the disease framework(Before surgery and 24 months after surgery)