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临床试验/NCT02281487
NCT02281487已完成不适用

Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy

Gynaecologisch Oncologisch Centrum Zuid9 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
9
主要终点
Anti Mullerian Hormone

研究概览

简要总结

The purpose of this study is to determine whether a tubectomy during hysterectomy for benign gynaecological conditions does not result into a premature menopause.

详细描述

RATIONALE Recent studies in women at hereditary high risk to develop ovarian cancer indicate that high grade serous carcinomas arise from (ectopic and/or dysplastic) tubal epithelium. Historically, in pre-menopausal women undergoing a hysterectomy for benign indications (such as bleeding disorders, fibroids and adenomyosis) adnexa, including the Fallopian tubes, are left in situ. However, removing the tubes during a hysterectomy potentially prevents the development of serous ovarian carcinomas. Such a simple preventive procedure should avoid serious adverse effects of adnexectomy, like premature ovarian failure (POF).

STUDY DESIGN This is a randomized controlled trial in which patients undergoing a hysterectomy for benign indications will either be included into a group in which a standard hysterectomy (abdominal or laparoscopic) will be performed or into a group in which hysterectomy (abdominal or laparoscopic) will be combined with salpingectomy.The accrual is aimed to take until July 2015 and will be performed in the regular clinical setting.

STUDY POPULATION Women undergoing hysterectomy for benign conditions (fibroids, endosalpingiosis, bleeding disorders, etc) either abdominal or laparoscopic.

SAMPLE SIZE N=50/arm

TREATMENT Hysterectomy (abdominal or laparoscopic) with or without bilateral tubectomy.

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

年龄范围
36 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • hysterectomy (abdominally or laparoscopically) for benign indications
  • premenopausal
  • age >36 < 55

排除标准

  • history of cancer
  • hereditary cancer in the family
  • previous intraluminal tubal occlusion
  • previous salpingitis
  • failure to perform a tubectomy during hysterectomy

结局指标

主要结局

Anti Mullerian Hormone

时间窗: at baseline and on average six months after the operation

Difference, if any, in concentration of Anti Mullerian Hormone one day prior to hysterectomy and on average around six months after surgery between the study groups (hysterectomy alone versus hysterectomy and tubectomy).

次要结局

  • Dysplasia(on average six months after the operation)

研究者

发起方
Gynaecologisch Oncologisch Centrum Zuid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jurgen M.J. Piek

MD. PhD.

Gynaecologisch Oncologisch Centrum Zuid

研究点 (9)

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