Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
研究概览
简要总结
The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.
详细描述
To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.
Primary outcome: anatomical cure rate (using simplified POP-Q staging system)
Secondary outcomes:
complication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater
排除标准
- •Poor health status with inability to undergo general anaesthesia
- •Age < 18 years
- •≥ 3 previous laparotomic surgeries
- •Planned pregnancy
- •Other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (Lupus, Sjogren Sdr, sclerodermia, etc.), current UTI's, use of steroids, anticoagulants, interstitial cystitis
研究组 & 干预措施
Women with pelvic organ prolapse
Women with pelvic organ prolapse (simplified POP-Q > stage 1)
干预措施: Robotic assisted sacrocolpopexy (RASC) (Procedure)
结局指标
主要结局
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
时间窗: 6 months
anatomical cure (defined as any simplified POP-Q point \<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.
次要结局
- quality of life(6 weeks, 6 months, 1 year (yearly thereafter, if feasible))
- intra- peri- and postoperative complications(intraoperative to 6 weeks after surgery)
- anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)(1 year, yearly thereafter (if feasible))
- intraoperative variables(intraoperative)
- impact of uterus management(6 weeks, 6 months, 1 year (yearly thereafter, if feasible))
- postoperative pain(on postoperative day 1)
研究者
Femke van Zanten
Study Coordinator, urologist, urogynaecology fellow
Cork University Hospital