Hickey Martha, Trainer Alison, Braat Sabine, Davey Mary-Ann, Krejany Efrosinia, Wark John
Department of Obstetrics and Gynaecology, The Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
BMJ Open. 2017 Nov 14;7(11):e018758. doi: 10.1136/bmjopen-2017-018758.
Women at high inherited risk of ovarian cancer are advised to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) at age 40-45 years or when their families are complete. Most women are premenopausal at this age, so RRBSO will induce surgical menopause. Despite the clear benefits of RRBSO for cancer risk reduction, much less is known about the impact on non-cancer outcomes that contribute to health and well-being and inform surveillance and management strategies.
This will be a multicentre, prospective cohort study of 105 premenopausal high-risk women undergoing RRBSO and an age-matched comparison group of 105 premenopausal women not planning oophorectomy or pregnancy in the next 2 years. The aim of this study is to measure the impact of RRBSO on sexual function (primary outcome) at 24 months in high-risk premenopausal women compared with the comparison group. Secondary outcomes include menopausal symptoms and menopause-related quality of life, mood, sleep quality, markers of cardiovascular disease and pre-diabetes, bone density and markers of bone turnover, and the impact of hormone replacement therapy use on these outcomes. Data analysis methods will include logistic and linear regression using general estimating equations accounting for the repeated outcome measurements within each participant.
The study has been approved by institutional ethics committees at each participating centre. Findings will be disseminated through peer-reviewed publications and conference presentations, and national and international networks of centres managing high-risk women, and will inform national and international clinical guidelines.
The pre-results protocol for this trial is registered with the Australian New Zealand Clinical Trials Registry (anzctr.org.au; registration no: ACTRN12615000082505).
对于卵巢癌遗传风险高的女性，建议在40 - 45岁或完成生育后进行降低风险的双侧输卵管卵巢切除术（RRBSO）。这个年龄段的大多数女性处于绝经前，因此RRBSO会导致手术绝经。尽管RRBSO在降低癌症风险方面有明显益处，但对于其对有助于健康和幸福以及为监测和管理策略提供依据的非癌症结局的影响，我们了解得要少得多。
这将是一项多中心前瞻性队列研究，研究对象为105名接受RRBSO的绝经前高危女性，以及一个年龄匹配的对照组，该对照组由105名在未来2年内不计划进行卵巢切除术或怀孕的绝经前女性组成。本研究的目的是在24个月时测量RRBSO对高危绝经前女性性功能（主要结局）的影响，并与对照组进行比较。次要结局包括绝经症状和与绝经相关的生活质量、情绪、睡眠质量、心血管疾病和糖尿病前期的标志物、骨密度和骨转换标志物，以及激素替代疗法的使用对这些结局的影响。数据分析方法将包括使用广义估计方程的逻辑回归和线性回归，以考虑每个参与者内的重复结局测量。
该研究已获得各参与中心的机构伦理委员会批准。研究结果将通过同行评审出版物、会议报告以及管理高危女性的国家和国际中心网络进行传播，并为国家和国际临床指南提供参考。
本试验的预结果方案已在澳大利亚新西兰临床试验注册中心（anzctr.org.au；注册号：ACTRN12615000082505）注册。
