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

NCT04470921 | Unknown

• 1 other identifier: 2018-1; 11515
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

Risk Reduction; Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Offered Opportunistic Salpingectomy (OS)

  Number of eligible women who have actually been offered an opportunistic salpingectomy in the Netherlands.

  2019 - 2023

• Implementation effect of Opportunistic Salpingectomy (OS)

  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 Outcomes (2)

• Influencing factors implementation Opportunistic Salpingectomy (OS)

  2019-2020

• Implementation tools

  2019-2020

Study Arms (1)

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

Interventions

Opportunistic Salpingectomy PROCEDURE

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.

Choice for Opportunistic Salpingectomy

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (27)

Jeroen Bosch Hospital

's-Hertogenbosch, 5223 GZ, Netherlands

Location

OLVG

Amsterdam, 1091 AC, Netherlands

Location

Academic Medical Centrum

Amsterdam, 1105AZ, Netherlands

Location

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Amphia hospital

Breda, 4818 CK, Netherlands

Location

Reinier de Graaf

Delft, 2625 AD, Netherlands

Location

Slingeland Hospital

Doetinchem, 7009 BL, Netherlands

Location

Albert Schweitzer hospital

Dordrecht, 3300 AK, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Medical Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Martini hospital

Groningen, 9728 NT, Netherlands

Location

Spaarne Gasthuis

Haarlem, 2000 AK, Netherlands

Location

Ziekenhuisgroep Twente

Hengelo, 7555 DL, Netherlands

Location

Medical Center Leewarden

Leeuwarden, 8934 AD, Netherlands

Location

Leids University Medical Center

Leiden, 2300 RC, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

St Antonius

Nieuwegein, 3434 CM, Netherlands

Location

Radboud UMC

Nijmegen, 6525 GA, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, 6532 SZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Haaglanden Medical Center Westeinde

The Hague, 2512 VA, Netherlands

Location

Elisabeth-Tweesteden Hospital

Tilburg, 5042 AD, Netherlands

Location

Diakonessenhuis

Utrecht, 3508 TG, Netherlands

Location

Maxima Medical Center

Veldhoven, 5500 MB, Netherlands

Location

VieCuri Medical Center

Venlo, 5801 CE, Netherlands

Location

Sint Jans Gasthuis

Weert, 6001 BE, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 26773418 BACKGROUND

• 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.

  PMID: 25568991 BACKGROUND

• 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.

  PMID: 31456223 BACKGROUND

• 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.

  PMID: 30479086 BACKGROUND

• 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.

  PMID: 25560145 BACKGROUND

• 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.

  PMID: 28527613 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

NL (27)