Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
NCT ID: NCT04757922
Last Updated: 2024-01-26
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
1200 participants
OBSERVATIONAL
2021-03-01
2036-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention: bilateral salpingectomy
Premenopausal women between 30 and 45 years of age, who will undergo sterilization through Opportunistic Salpingectomy will be asked to participate in the STOPOVCAyoung study.
Opportunistic salpingectomy / bilateral salpingectomy
An opportunistic salpingectomy refers to removal of the salpinges without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases. Therefore, a so-called opportunistic salpingectomy is a method of female sterilization.
Control: tubal ligation or no sterilization
The control group will consists of women who chose for sterilization by clips/tubal ligation supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.
No interventions assigned to this group
Interventions
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Opportunistic salpingectomy / bilateral salpingectomy
An opportunistic salpingectomy refers to removal of the salpinges without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases. Therefore, a so-called opportunistic salpingectomy is a method of female sterilization.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
45 Years
FEMALE
Yes
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jurgen MJ Piek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis
Joanne A de Hullu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Nijmegen
Locations
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Catharina Ziekenhuis
Eindhoven, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-6885
Identifier Type: -
Identifier Source: org_study_id
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