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NCT04470921 Clinical Trial

STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands

Ovarian Cancer Clinical Trial

— STOPOVCA  

Official title:
STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04470921
Other study ID # 2018-1; 11515
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2025

Study information
Verified date January 2024
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands.

Description:

The investigators aim to optimize implementation of opportunistic salpingectomy throughout the Netherlands. The investigators will evaluate the implementation by enrolling patients in a database to evaluate healthcare experiences and to register EOC diagnosis and vital status through yearly PALGA (the nationwide network and registry of histopathology and cytopathology in the Netherlands) and municipal administration searches. In addition, the investigators will perform medical record check to assess which percentage of eligible women have been offered OS. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10000
Est. completion date December 31, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 30 Years and older
Eligibility Inclusion Criteria: - Age from 30 years - 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: - Age under 30 years - Undergoing surgery without residual ovarian tissue - Child wish - Unable to understand the written or spoken Dutch language - Previous bilateral salpingectomy - Previous bilateral salpingo-oophorectomy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
Netherlands Jeroen Bosch Hospital 's-Hertogenbosch
Netherlands Academic Medical Centrum Amsterdam
Netherlands OLVG Amsterdam
Netherlands Rijnstate Hospital Arnhem
Netherlands Amphia hospital Breda
Netherlands Reinier de Graaf Delft
Netherlands Haaglanden Medical Center Westeinde Den Haag
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 Canisius Wilhelmina Hospital Nijmegen
Netherlands Radboud UMC Nijmegen
Netherlands Erasmus Medical Center Rotterdam
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

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Medical Center Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. Erratum In: Obstet Gynecol. 2016 Feb;127(2):405. Obstet Gynecol. 2016 Feb;127(2):405. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Offered Opportunistic Salpingectomy (OS) Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands. 2019 - 2023
Primary Implementation effect of Opportunistic Salpingectomy (OS) The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands. 2019-2023
Secondary Influencing factors implementation Opportunistic Salpingectomy (OS) Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy. 2019-2020
Secondary Implementation tools Implementation tools, developed based on the barriers and facilitators of the influencing factors. 2019-2020
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