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| Name | Class |
|---|---|
| Catharina Ziekenhuis Eindhoven | OTHER |
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The aim of this study is to evaluate the long-term safety of on the onset of menopause.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Decision regret | The decision regret regarding their choice of sterilization method. | 1 year post surgery and at age of menopause |
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Inclusion Criteria:
Intervention group
Control group
Exclusion Criteria:
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Women who underwent sterilization (bilateral salpingectomy / tubal ligation) supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.
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| Name | Affiliation | Role |
|---|---|---|
| Jurgen MJ Piek, MD, PhD | Catharina Ziekenhuis | Principal Investigator |
| Joanne A de Hullu, MD, PhD | University Medical Center Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11745677 | Background | 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. | |
| 24518912 | Background |
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| 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. |
| 25628372 | 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. |
| 31456223 | 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. |
| 29852159 | 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. |
| 27261215 | 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. |
| 35337614 | Derived | 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. |