Clinical trial NCT04757922: Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Official title: Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Salpingectomy
Tubal Ligation
Menopause
Keywords: Salpingectomy
Sterilization
Tubal ligation
Opportunistic salpingectomy
Menopausal age
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2021-02-17
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent sterilization (bilateral salpingectomy / tubal ligation) supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.

Brief summary: The aim of this study is to evaluate the long-term safety of on the onset of menopause.

Detailed description: The aim of this study is to evaluate the long-term safety of on the onset of menopause. To investigate the effect of Opportunistic Salpingectomy on the age of menopause, we will compare age of menopause in women who underwent sterilization through opportunistic salpingectomy with a control group consisting of women who underwent sterilization by tubal ligation or who had no sterilization.

Eligibility criteria: Inclusion Criteria:

Intervention group

* Undergoing an Opportunistic Salpingectomy as sterilization method
* Premenopausal status at enrolment
* Age between 30 and 45 years
* Will have residual ovarian tissue after surgery
* Able to understand the written or spoken Dutch language
* Gives consent for participating in surveys

Control group

* Premenopausal status at enrolment
* Either sterilization by tubal ligation or no sterilization at all
* Age between 35 and 45 years
* Able to understand the written or spoken Dutch language
* Gives consent for participating in surveys

Exclusion Criteria:

* Postmenopausal status at enrolment
* Under the age of 35 or above 45
* Previous salpingectomy of oophorectomy
* Previous hysterectomy
* Women with abnormal karyotype (such as Turner Syndrome and Fragile X syndrome)
* Underwent chemotherapy or radiation
* Unable to understand the written or spoken Dutch language

Primary outcomes:
measure: Menopausal age
timeFrame: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)
Secondary outcomes:
measure: Decision regret
timeFrame: 1 year post surgery and at age of menopause
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Catharina Ziekenhuis
name: Jurgen MJ Piek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Nijmegen
name: Joanne A de Hullu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piek JM, van Diest PJ, Zweemer RP, Jansen JW, Poort-Keesom RJ, Menko FH, Gille JJ, Jongsma AP, Pals G, Kenemans P, Verheijen RH. Dysplastic changes in prophylactically removed Fallopian tubes of women predisposed to developing ovarian cancer. J Pathol. 2001 Nov;195(4):451-6. doi: 10.1002/path.1000.
citation: Reade CJ, McVey RM, Tone AA, Finlayson SJ, McAlpine JN, Fung-Kee-Fung M, Ferguson SE. The fallopian tube as the origin of high grade serous ovarian cancer: review of a paradigm shift. J Obstet Gynaecol Can. 2014 Feb;36(2):133-140. doi: 10.1016/S1701-2163(15)30659-9.
citation: Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
citation: van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2.
citation: Hanley GE, Kwon JS, Finlayson SJ, Huntsman DG, Miller D, McAlpine JN. Extending the safety evidence for opportunistic salpingectomy in prevention of ovarian cancer: a cohort study from British Columbia, Canada. Am J Obstet Gynecol. 2018 Aug;219(2):172.e1-172.e8. doi: 10.1016/j.ajog.2018.05.019. Epub 2018 May 28.
citation: McAlpine JN, Tone AA, Hanley GE. Opportunistic Salpingectomy: We Chose to Act, Not Wait. J Obstet Gynaecol Can. 2016 May;38(5):425-7. doi: 10.1016/j.jogc.2016.04.084. Epub 2016 May 6. No abstract available.
citation: Gelderblom ME, IntHout J, Hermens RPMG, Coppus SFPJ, Ebisch I, van Ginkel AA, van de Laar R, de Lange N, Maassen M, Pijlman B, Smedts HPM, Vos MC, Beerendonk CCM, de Hullu JA, Piek JMJ. 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. Maturitas. 2022 May;159:62-68. doi: 10.1016/j.maturitas.2022.01.006. Epub 2022 Jan 15.