NCT03487328已完成不适用
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: 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
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with recurrence of uterovaginal and vaginal vault prolapse
研究概览
简要总结
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 60 years.
- •POP Q stage III & IV
- •Uterovaginal prolapse.
- •Vaginal vault prolapse.
排除标准
- •Age > 40 years or < 60 years.
- •POP Q stage I or II.
- •Previous repair of uterovaginal or vaginal vault prolapse.
- •Comorbidity with Stress Urinary Incontinence.
- •Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
- •Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
结局指标
主要结局
Number of participants with recurrence of uterovaginal and vaginal vault prolapse
时间窗: 1 year
次要结局
- blood loss(intraoperative)
- Injury to surrounding structures(intraoperative)
- operative time(intraoperative)
研究者
Mohamed S Sweed, MD
Principal Investigator
Ain Shams University
研究点 (1)
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