Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Longitudinal changes of FSH pre- and post-operatively
研究概览
简要总结
Two recently published articles need to be cited to explain the rationale for our study since both studies conclude with contrary findings: The first one is "The post-reproductive Fallopian tube: better removed?" and the other is termed "Factors associated with age of onset and type of menopause in a cohort of UK women".
In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed that pelvic surgical procedures and even simple tubal sterilization are associated with an earlier menopause. Hence, this is an important issue as early menopause leads to adverse health status.
详细描述
Two study findings lead to conflictive points of view. On the one hand a routine removal of the Fallopian tubes is proclaimed to reduce cancer risk, on the other hand we know that surgical pelvic procedures result in early onset of menopause. Pokoradi et al were not able to distinctively tell which part of pelvic surgery (ie hysterectomy, oophorectomy, salpingectomy, tubal ligation?) is affecting menopause because data was not providing surgical details. Nevertheless, Dietl et al's statement "Timing of menopause and other long-term effects have not been studied yet...thus all negative effects are still speculative"1 can only partly be agreed upon regarding Pokoradi's findings. It might be too early to proclaim a routine Fallopian tube removal as long as there is no data on how much this procedure affects ovarian function. This is further supported by another statement in their study "Although most malignant serous "ovarian" carcinomas originate from the distal Fallopian tube, a smaller proportion of serous cancers as well as endometroid, clear cell, mucinous carcinomas are still thought to arise from ovarian surface epithelium.1" which means the exact impact on cancer prophylaxis can only be estimated due to a lack of studies. Other histopathologic entities might not be influenced by tube removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •benign indication for hysterectomy
- •informed consent
排除标准
- •Menopause
- •Pregnancy
- •Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
- •malignancy
- •hormone replacement therapy
结局指标
主要结局
Longitudinal changes of FSH pre- and post-operatively
时间窗: 6 weeks
Follicle-stimulating hormone (U/l)
次要结局
- Longitudinal changes of LH(1 year)
- Longitudinal changes of E2(1 year)
- Longitudinal changes of FSH(1 year)
- Longitudinal changes of AMH(1 year)
