NL-OMON54613招募中不适用
Evaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH). - SAM-trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Women with symptomatic pelvic organ prolapse including uterine descent. The
- •prolapse may be at any stage but POP-Q point D may not exceed minus 1cm.
- •Community dwelling
- •Capable of filling out questionnaires
- •Patients from the hospitals in Nijmegen, Zwolle, Almelo, Hengelo and Enschede)
- •are asked to participate in a supine and upright MRI scan at the University of
排除标准
- •- < 18 years
- •- Previous prolapse or other pelvic floor surgery Previous POP surgery
- •- Previous incontinence surgery
- •- POP-Q longer than 3 months ago at randomisation
- •- Need or wish for removal of the uterus
- •- Need for concomitant mid-urethral sling surgery
- •- Contraindication to uterus preservation (in case indicated, a pap-smear
- •and/or pipelle endometrial biopsy should be normal before inclusion)
- •- Pregnancy or future wish for childbearing
- •- Insufficient understanding and reading of the Dutch language
- •- Not capable of filling out questionnaires
- •For the facultative MRI study additional exclusion criteria are in order,
- •- Inability to stand for 15 minutes without assistance
- •- Hip width> 47cm (jeans size >44)
- •- Not allowed to do a maximum Valsalva manoeuvre because of cardiac or
- •pulmonary disease
- •- Not eligible for MRI, in response to the MRI safety checklist
研究者
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