Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 9
- 主要终点
- percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
研究概览
简要总结
The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.
详细描述
Hysterectomy is one of the most common gynecologic procedures performed in clinical practice. In this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment.
the standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.
impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6 weeks and 6, 12 months after surgeries.
quality of life is also assessed at these time points, with a questionnaire (Women Health Questionnaire WHQ).
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
- Double (Participant, Outcomes Assessor)
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
- •age ≥ 18 years and less than 52 years
- •indication of a conservative hysterectomy for benign disease
- •signed informed consent
- •non menopausal women (AMH >0,21 ng/ml)
排除标准
- •pregnancy
- •desire of future pregnancy
- •menopausal status
- •patient unable to give informed consent
- •any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection
- •previous salpingo and /or oophorectomy (unilateral or bilateral)
- •genital cancer disease or atypical endometrial hyperplasia
- •hyperandrogenia
- •any ovarian mass that needs surgical exploration
- •any immunotherapy that could interfere with immunological tests
研究组 & 干预措施
conservative hysterectomy I
bilateral salpingectomy during hysterectomy with conservation of the ovaries
干预措施: conservative hysterectomy I (Procedure)
conservative hysterectomy II
standard conservative hysterectomy with conservation of both ovaries and tubes
干预措施: Conservative hysterectomy II (Procedure)
结局指标
主要结局
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
时间窗: one year
次要结局
- AMH measurement at 3 days, 6 weeks, and 6, 12 months after hysterectomy endovaginal ultrasound evaluation of the ovarian volume and vascularisation quality of life (WHQ questionnaire) reintervention procedures complications(day3, week 6, month 6 and month 12)