Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain
研究概览
简要总结
Adenomyosis is a disease where ectopic endometrial-like glands affect the muscular wall of the uterus. About 70% of women affected by adenomyosis suffer from dysmenorrhea and menorrhagia. A levonorgestrel-releasing intrauterine device (LNG-IUD) is the first-choice treatment of adenomyosis, but is not always sufficiently effective in all women. Those women often end up removing the uterus (hysterectomy).
Hysterectomy is clinically regarded to be an efficient and final treatment of adenomyosis, but pelvic pain may also prevail after removal of the uterus. This study aimes to investigate the short - and long-term impact of hysterectomy on quality of life (QOL) and sexual function in women with adenomyosis, and further to evaluate if there is any difference compared to women that are removing their uterus due to other benign gynecological conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal status defined by having had menstruation within the last 12 months, or age < 50 years if amenorrhea due to hormonal treatment
- •Hysterectomy planned due to a benign condition
- •Able to communicate in Norwegian or English
- •Electronic consent given
排除标准
- •Age < 18 years, postmenopausal status or no menstrual bleeding for the last 12 months
- •Hysterectomy as part of female-to-male transition
- •Pelvic organ prolapse as an indication for hysterectomy
- •Gynecological cancer suspected at the time of inclusion
- •Not able to communicate in Norwegian or English
结局指标
主要结局
The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain
时间窗: 1 year
The Short Form Health Survey (SF-36) measures eight sub scales including bodily pain (BP) which in this study is used as primary outcome. The scales ranges from 0-100, a higher score indicates a better quality of life.
次要结局
- The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales(5 years)
- The impact of hysterectomy on sexual function assessed by FSFI(5 years)
- The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales(5 years)
研究者
Marianne Omtvedt
Principal Investigator
Oslo University Hospital