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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04470921
Acronym
STOPOVCA
Enrollment
10000
Registered
2020-07-14
Start date
2019-01-01
Completion date
2025-12-31
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Risk Reduction

Keywords

Ovarian cancer, Opportunistic Salpingectomy, Prevention, Female sterilization, Risk reduction, Implementation

Brief summary

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

Detailed 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.

Interventions

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.

Sponsors

Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Offered Opportunistic Salpingectomy (OS)2019 - 2023Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
Implementation effect of Opportunistic Salpingectomy (OS)2019-2023The effect of our implementation efforts on the number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.

Secondary

MeasureTime frameDescription
Influencing factors implementation Opportunistic Salpingectomy (OS)2019-2020Determine factors that impede and facilitate nationwide implementation of Opportunistic Salpingectomy.
Implementation tools2019-2020Implementation tools, developed based on the barriers and facilitators of the influencing factors.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026