NCT03582410已完成不适用
Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of patients with anatomical correction of the prolapse
研究概览
简要总结
This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.
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
- 40 Years 至 75 Years（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
结局指标
主要结局
Number of patients with anatomical correction of the prolapse
时间窗: 1 year
Anatomical correction of the prolapse evaluated by gynecological visit
次要结局
- long term outcomes(1 year)
- rate mesh erosion(1 year)
- Rate of recurrence(1 year)
研究者
Maurizio Guido
Clinical Professor
Catholic University of the Sacred Heart
研究点 (1)
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