跳至主要内容
临床试验/NCT02669498
NCT02669498已完成不适用

Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal

Insel Gruppe AG, University Hospital Bern4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2013年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验