Clinical trial NCT04470921: STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands
Official title: STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Risk Reduction
Ovarian Cancer
Keywords: Ovarian cancer
Opportunistic Salpingectomy
Prevention
Female sterilization
Risk reduction
Implementation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2020-07-14
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Offered Opportunistic Salpingectomy (OS)
timeFrame: 2019 - 2023
measure: Implementation effect of Opportunistic Salpingectomy (OS)
timeFrame: 2019-2023
Secondary outcomes:
measure: Influencing factors implementation Opportunistic Salpingectomy (OS)
timeFrame: 2019-2020
measure: Implementation tools
timeFrame: 2019-2020
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: Academic Medical Centrum
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center Westeinde
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Enschede
country: Netherlands
facility: Medical Spectrum Twente
city: Groningen
country: Netherlands
facility: Martini hospital
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Leeuwarden
country: Netherlands
facility: Medical Center Leewarden
city: Leiden
country: Netherlands
facility: Leids University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St Antonius
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Tilburg
country: Netherlands
facility: Elisabeth-Tweesteden Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
city: Weert
country: Netherlands
facility: Sint Jans Gasthuis
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: University Medical Center Nijmegen
name: Joanne A de Hullu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Jurgen MJ Piek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scietific Institute for Quality of Healthcare, UMC Nijmegen
name: Rosella PM Hermens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.