STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands
- Conditions
- Ovarian CancerRisk Reduction
- Interventions
- Procedure: Opportunistic Salpingectomy
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 10000
- 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
- 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
- Arm && Interventions
Group Intervention Description Choice for Opportunistic Salpingectomy 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.
- 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)
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Elisabeth-Tweesteden Hospital
🇳🇱Tilburg, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
Maxima Medical Center
🇳🇱Veldhoven, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
Slingeland Hospital
🇳🇱Doetinchem, Netherlands
Academic Medical Centrum
🇳🇱Amsterdam, Netherlands
Amphia hospital
🇳🇱Breda, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Reinier de Graaf
🇳🇱Delft, Netherlands
Haaglanden Medical Center Westeinde
🇳🇱Den Haag, Netherlands
Medical Spectrum Twente
🇳🇱Enschede, Netherlands
Ziekenhuisgroep Twente
🇳🇱Hengelo, Netherlands
Isala
🇳🇱Zwolle, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
Medical Center Leewarden
🇳🇱Leeuwarden, Netherlands
Leids University Medical Center
🇳🇱Leiden, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Canisius Wilhelmina Hospital
🇳🇱Nijmegen, Netherlands
VieCuri Medical Center
🇳🇱Venlo, Netherlands
Sint Jans Gasthuis
🇳🇱Weert, Netherlands
Jeroen Bosch Hospital
🇳🇱's-Hertogenbosch, Netherlands
Albert Schweitzer hospital
🇳🇱Dordrecht, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Martini hospital
🇳🇱Groningen, Netherlands
St Antonius
🇳🇱Nieuwegein, Netherlands