A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correction of pelvic organ prolapse
研究概览
简要总结
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
排除标准
- •Age > 75 years
- •Severe cardiovascular or respiratory disease
- •Pregnancy
研究组 & 干预措施
posterior mesh no attachment
laparoscopic sacral colpopexy with no fixation of posterior mesh
干预措施: laparoscopic sacral colpopexy with posterior mesh no attachment (Procedure)
posterior mesh attachment
laparoscopic sacral colpopexy with fixation of posterior mesh by suture
干预措施: laparoscopic sacral colpopexy with posterior mesh attachment (Procedure)
结局指标
主要结局
correction of pelvic organ prolapse
时间窗: 1 year
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
次要结局
- rate of recurrence(1 year)
- long term outcomes(1 year)
研究者
Maurizio Guido
principal investigator, Director of gynaecologic and obstetric department
Catholic University of the Sacred Heart