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

NCT04757922 | Enrolling By Invitation

• 1 other identifier: 2020-6885
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salpingectomy; Tubal Ligation; Menopause

Keywords

Salpingectomy; Sterilization; Tubal ligation; Opportunistic salpingectomy; Menopausal age

Outcome Measures

Primary Outcomes (1)

• Menopausal age

  The age of reaching natural menopause (e.g. last menstruation \> 1 year ago )

  At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)

Secondary Outcomes (1)

• Decision regret

  1 year post surgery and at age of menopause

Study Arms (2)

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.

Procedure: Opportunistic salpingectomy / bilateral salpingectomy

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.

Interventions

Opportunistic salpingectomy / bilateral salpingectomy PROCEDURE

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.

Intervention: bilateral salpingectomy

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35337614 DERIVED

Study Officials

• Jurgen MJ Piek, MD, PhD

  Catharina Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Joanne A de Hullu, MD, PhD

  University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2036
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

NL (1)