NCT00876057已完成4 期
Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.
University Hospital, Linkoeping14 个研究点 分布在 1 个国家目标入组 200 人开始时间: 1998年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Psychological well-being
研究概览
简要总结
The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.
Se also Detailed Description for additional study.
详细描述
An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible
- •After surgery at least one ovary preserved.
- •Informed verbal and written consent
- •Proficiency in Swedish
排除标准
- •Malignancy in the genital organs.
- •Previous or present cervical dysplasia.
- •Rapidly growing fibroids where malignancy could not be ruled out
- •Preoperative treatment with GnRH analogues.
- •Postmenopausal women without hormone therapy
- •Severe psychiatric disorder
结局指标
主要结局
Psychological well-being
时间窗: One year after surgery
次要结局
- Recovery of general well-being(Five weeks after surgery)
- Sexuality(One year)
- Pelvic organ prolapse (anatomical)(7-14 years)
- Patient reported symptoms of pelvic organ dysfunction(7-14 years)
研究者
Preben Kjolhede
Professor
University Hospital, Linkoeping
研究点 (14)
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