NCT00988975Unknown不适用
Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?
Urogynecology Associates, Indiana4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Anatomic success of rectocele repair
研究概览
简要总结
Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy
排除标准
- •concomitant colo-rectal procedure
- •allergy to pork
- •any contraindication to laparoscopic sacrocolpopexy
结局指标
主要结局
Anatomic success of rectocele repair
时间窗: 6 months
次要结局
- change in patient symptomatology post-operatively(6 months)
研究者
研究点 (4)
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