Interventional Gynecologic Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- uterine bleeding
研究概览
简要总结
Prospective observational interventional study , The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
详细描述
Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.
Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.
Patients and Methods: The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 34 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis
排除标准
- •patients wishing future fertility
- •endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume
结局指标
主要结局
uterine bleeding
时间窗: October 2011 till January 2016
次要结局
- patient satisfaction(october 2011 - may 2015)
- quality of life(october 2011 - may 2015)
研究者
Emad Mohamad Sedeek
professor
Mansoura Integrated Fertility Center