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Enrolling by invitation NCT04757922

Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause

— Observational Salpingectomy Tubal Ligation Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opportunistic salpingectomy / bilateral salpingectomy.
Who it may be relevant to
Registry conditions: Salpingectomy, Tubal Ligation, Menopause. Basic parameters: 30 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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.

Primary outcome measures

  • Menopausal age [Time frame: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)]
Secondary outcome measures (1)
  • Decision regret [Time frame: 1 year post surgery and at age of menopause]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Catharina Ziekenhuis — Eindhoven

Publications

  • 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. PMID 11745677
  • 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. PMID 24518912
  • 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. PMID 25628372
  • 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. PMID 31456223
  • 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. PMID 29852159
  • 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. PMID 27261215
  • 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. PMID 35337614

Identifiers

NCT: NCT04757922 · 2020-6885

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗