STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands
NCT ID: NCT04470921
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
10000 participants
OBSERVATIONAL
2019-01-01
2025-12-31
Brief Summary
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Detailed Description
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The investigators expect that a decision aid will be a necessary tool for the decision whether women opt for an OS or not, based on their personal values. After development of the tool(s), the investigators will evaluate the implementation process.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Choice for Opportunistic Salpingectomy
Women who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.
Opportunistic Salpingectomy
An opportunistic salpingectomy refers to removal of the fallopian tubes without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases.
Interventions
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Opportunistic Salpingectomy
An opportunistic salpingectomy refers to removal of the fallopian tubes without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases.
Eligibility Criteria
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Inclusion Criteria
* Undergoing gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved
* Childbearing completed
* Able to understand the written or spoken Dutch language
* Consent for enrolment in database
* Consent for yearly checks of PALGA database and municipal administration
Exclusion Criteria
* Undergoing surgery without residual ovarian tissue
* Child wish
* Unable to understand the written or spoken Dutch language
* Previous bilateral salpingectomy
* Previous bilateral salpingo-oophorectomy
30 Years
FEMALE
No
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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Joanne A de Hullu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Nijmegen
Jurgen MJ Piek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Rosella PM Hermens, PhD
Role: PRINCIPAL_INVESTIGATOR
Scietific Institute for Quality of Healthcare, UMC Nijmegen
Locations
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Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
OLVG
Amsterdam, , Netherlands
Academic Medical Centrum
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Amphia hospital
Breda, , Netherlands
Reinier de Graaf
Delft, , Netherlands
Slingeland Hospital
Doetinchem, , Netherlands
Albert Schweitzer hospital
Dordrecht, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Medical Spectrum Twente
Enschede, , Netherlands
Martini hospital
Groningen, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Ziekenhuisgroep Twente
Hengelo, , Netherlands
Medical Center Leewarden
Leeuwarden, , Netherlands
Leids University Medical Center
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
St Antonius
Nieuwegein, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Canisius Wilhelmina Hospital
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haaglanden Medical Center Westeinde
The Hague, , Netherlands
Elisabeth-Tweesteden Hospital
Tilburg, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Maxima Medical Center
Veldhoven, , Netherlands
VieCuri Medical Center
Venlo, , Netherlands
Sint Jans Gasthuis
Weert, , Netherlands
Isala
Zwolle, , Netherlands
Countries
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References
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Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: A meta-analysis. Eur J Cancer. 2016 Mar;55:38-46. doi: 10.1016/j.ejca.2015.12.003. Epub 2016 Jan 8.
Kwon JS, McAlpine JN, Hanley GE, Finlayson SJ, Cohen T, Miller DM, Gilks CB, Huntsman DG. Costs and benefits of opportunistic salpingectomy as an ovarian cancer prevention strategy. Obstet Gynecol. 2015 Feb;125(2):338-345. doi: 10.1097/AOG.0000000000000630.
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.
Steenbeek MP, van Lieshout LAM, Aarts JWM, Piek JMJ, Coppus SFPJ, Massuger LFAG, Hermens RPMG, de Hullu JA. Factors influencing decision-making around opportunistic salpingectomy: a nationwide survey. J Gynecol Oncol. 2019 Jan;30(1):e2. doi: 10.3802/jgo.2019.30.e2. Epub 2018 Apr 30.
Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09.
Salvador S, Scott S, Francis JA, Agrawal A, Giede C. No. 344-Opportunistic Salpingectomy and Other Methods of Risk Reduction for Ovarian/Fallopian Tube/Peritoneal Cancer in the General Population. J Obstet Gynaecol Can. 2017 Jun;39(6):480-493. doi: 10.1016/j.jogc.2016.12.005.
Other Identifiers
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2018-1; 11515
Identifier Type: -
Identifier Source: org_study_id
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