停止卵巢癌（STOPOVCA）青年组：一项多中心随访研究的方案，以确定机会性输卵管切除术对绝经年龄的长期影响。
STop OVarian CAncer (STOPOVCA) young: Protocol for a multicenter follow-up study to determine the long-term effects of opportunistic salpingectomy on age at menopause.
作者信息
Gelderblom Malou E, IntHout Joanna, Hermens Rosella P M G, Coppus Sjors F P J, Ebisch Inge, van Ginkel Alexandra A, van de Laar Rafli, de Lange Natascha, Maassen Marloes, Pijlman Brenda, Smedts Huberdina P M, Vos M Caroline, Beerendonk Catharina C M, de Hullu Joanne A, Piek Jurgen M J
机构信息
Radboud Institute for Health Sciences, Department of Obstetrics and Gynecology, Radboud University Medical Centre, Nijmegen, the Netherlands; Department of Obstetrics and Gynecology and Catharina Cancer Institute, Catharina Hospital, Eindhoven, the Netherlands.
Radboud Institute for Health Sciences, Department for Health Evidence, Radboud university medical center, Nijmegen, the Netherlands.
出版信息
Maturitas. 2022 May;159:62-68. doi: 10.1016/j.maturitas.2022.01.006. Epub 2022 Jan 15.
BACKGROUND
Opportunistic salpingectomy comprises additional bilateral salpingectomy during abdominal surgery as a prophylactic method to reduce the risk of ovarian cancer. However, opportunistic salpingectomy may potentially damage (micro)blood circulation to the ovaries, resulting in earlier onset of menopause.
PRIMARY OBJECTIVE
To evaluate the long-term effects of opportunistic salpingectomy on the onset of menopause in women who underwent sterilization through salpingectomy compared with a control group who underwent sterilization by tubal ligation or no surgery at all.
STUDY HYPOTHESIS
Opportunistic salpingectomy does not lower the mean age at onset of menopause.
TRIAL DESIGN
In a multicenter observational noninferiority study, we will prospectively compare the age at menopause of women initially aged 35-45 who underwent sterilization through opportunistic salpingectomy with a similarly aged control group who underwent sterilization by tubal ligation or no sterilization. Participants will be asked to complete an annual questionnaire on onset of menopause to eventually determine whether there is more than a one-year decrease in mean age at onset of menopause in the opportunistic salpingectomy group. Follow-up will last until determination of menopause, with a maximum of 15 years.
MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion criteria: pre-menopausal; age between 35 and 45; intact ovaries.
EXCLUSION CRITERIA
post-menopausal; previous bilateral salpingectomy or oophorectomy; previous hysterectomy; abnormal karyotype; previous or current chemotherapy or pelvic radiation.
PRIMARY ENDPOINT(S): Determination of age of menopause measured by annual questionnaire.
SAMPLE SIZE
1200 (400 intervention group; 800 control group).
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
It is estimated that recruitment will be completed by 2023 and results will be published by 2039.
GOV IDENTIFIER
NCT04757922 PROTOCOL VERSION: : Version 1, February 2021.
背景
机会性输卵管切除术是指在腹部手术期间额外进行双侧输卵管切除术，作为降低卵巢癌风险的一种预防方法。然而，机会性输卵管切除术可能会潜在地损害卵巢的（微）血液循环，导致绝经提前。
主要目的
与通过输卵管结扎绝育或未进行手术的对照组相比，评估机会性输卵管切除术对通过输卵管切除术绝育的女性绝经 onset 的长期影响。
研究假设
机会性输卵管切除术不会降低绝经的平均年龄。
试验设计
在一项多中心观察性非劣效性研究中，我们将前瞻性地比较最初年龄在 35 - 45 岁、通过机会性输卵管切除术绝育的女性与年龄相仿、通过输卵管结扎绝育或未绝育的对照组的绝经年龄。参与者将被要求每年完成一份关于绝经 onset 的问卷，以最终确定机会性输卵管切除术组的绝经平均年龄是否下降超过一年。随访将持续到确定绝经，最长 15 年。
主要纳入/排除标准：纳入标准：绝经前；年龄在 35 至 45 岁之间；卵巢完整。
排除标准
绝经后；既往双侧输卵管切除术或卵巢切除术；既往子宫切除术；染色体核型异常；既往或目前的化疗或盆腔放疗。
主要终点
通过年度问卷确定绝经年龄。
样本量
1200（干预组 400 例；对照组 800 例）。
预计完成入组和公布结果的日期
预计招募将于 2023 年完成，结果将于 2039 年公布。
政府标识符
NCT04757922 方案版本：2021 年 2 月第 1 版。
Zotero 插件