STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands (STOPOVCA)

January 25, 2024 updated by: Radboud University Medical Center
The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Hospital
      • Amsterdam, Netherlands, 1091 AC
        • OLVG
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Centrum
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Breda, Netherlands, 4818 CK
        • Amphia Hospital
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf
      • Den Haag, Netherlands, 2512 VA
        • Haaglanden Medical Center Westeinde
      • Doetinchem, Netherlands, 7009 BL
        • Slingeland Hospital
      • Dordrecht, Netherlands, 3300 AK
        • Albert Schweitzer Hospital
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina hospital
      • Enschede, Netherlands, 7500 KA
        • Medical spectrum Twente
      • Groningen, Netherlands, 9728 NT
        • Martini Hospital
      • Haarlem, Netherlands, 2000 AK
        • Spaarne Gasthuis
      • Hengelo, Netherlands, 7555 DL
        • Ziekenhuisgroep Twente
      • Leeuwarden, Netherlands, 8934 AD
        • Medical Center Leewarden
      • Leiden, Netherlands, 2300 RC
        • Leids University Medical Center
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Nieuwegein, Netherlands, 3434 CM
        • St Antonius
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius Wilhelmina Hospital
      • Rotterdam, Netherlands, 3000 CA
        • Erasmus Medical Center
      • Tilburg, Netherlands, 5042 AD
        • Elisabeth-TweeSteden hospital
      • Utrecht, Netherlands, 3508 TG
        • Diakonessenhuis
      • Veldhoven, Netherlands, 5500 MB
        • Maxima Medical Center
      • Venlo, Netherlands, 5801 CE
        • Viecuri Medical Center
      • Weert, Netherlands, 6001 BE
        • Sint Jans Gasthuis
      • Zwolle, Netherlands, 8025 AB
        • Isala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who will undergo a gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved, can opt for an opportunistic salpingectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Offered Opportunistic Salpingectomy (OS)
Time Frame: 2019 - 2023
Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.
2019 - 2023
Implementation effect of Opportunistic Salpingectomy (OS)
Time Frame: 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.
2019-2023

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Catharina Ziekenhuis Eindhoven

Investigators

  • Principal Investigator: Joanne A de Hullu, MD, PhD, University Medical Center Nijmegen
  • Principal Investigator: Jurgen MJ Piek, MD, PhD, Catharina Ziekenhuis Eindhoven
  • Principal Investigator: Rosella PM Hermens, PhD, Scietific Institute for Quality of Healthcare, UMC Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1; 11515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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