Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Anatomic Success
研究概览
简要总结
Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.
详细描述
Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with stage 3 or more pelvic organ prolapse
排除标准
- •Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy
研究组 & 干预措施
Bilateral Abdominal Sacral Hysteropexy
Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
干预措施: Bilateral Abdominal Sacral Hysteropexy (Procedure)
Classic Abdominal Sacral Hysteropexy
Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
干预措施: Conventional abdominal Sacral Hysteropexy (Procedure)
Women with no uterovaginal prolapsed
Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
干预措施: Nulliparous women with no uterovaginal prolapsed (Other)
结局指标
主要结局
Anatomic Success
时间窗: One month
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
次要结局
未报告次要终点
研究者
Mehmet Baki Senturk
Principal Investigator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital