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

Active, not recruiting

• Conditions: Ovarian Cancer; Risk Reduction

• Registration Number: NCT04470921
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (27)

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

Haaglanden Medical Center Westeinde; 🇳🇱 Den Haag, Netherlands

Slingeland Hospital; 🇳🇱 Doetinchem, Netherlands

Albert Schweitzer hospital; 🇳🇱 Dordrecht, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

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