Hysterectomy and OPPortunistic SAlpingectomy

NCT ID: NCT03045965

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2053-12-31

Brief Summary

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason

• has no increased risk of complications
• has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures
• implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

Detailed Description

High grade serous ovarian cancer, the most fatal subtype, may originate in the fimbriae of the Fallopian tubes. This theory has led to the idea of opportunistic salpingectomy as a way of decreasing the risk of epithelial ovarian cancer (EOC). HOPPSA is a national register-based RCT, with randomization and follow-up in The Swedish National Quality Register of Gynecological Surgery (Gyn/Op).

HOPPSA aims to study if opportunistic salpingectomy is safe, and if it can reduce the risk of EOC.

PICO P (patients). Women <55 years, undergoing hysterectomy due to a benign reason I (intervention). Bilateral salpingectomy at the time of hysterectomy C (comparison). No salpingectomy O (outcomes). Primary short term: surgical complications reported according to Clavien-Dindo at 8 weeks post-operatively Intermediate term: change in menopausal symptoms from baseline to 1 year, assessed with Menopause Rating Scale Long term: ovarian cancer assessed through the National Cancer Register Recruitment of 4400 patients is estimated to take 4-6 years depending on the participation rate of the Swedish gynecological clinics. Data retrieval from GynOp on short and intermediate term outcomes, requiring smaller sample sizes, will be done at the end of the recruitment period. If these results, ready available when the study recruitment is closed, show that opportunistic salpingectomy does not increase surgical complications and menopausal symptoms, women can be advised to undergo salpingectomy to potentially minimize the future risk of EOC.

Conditions

Ovarian Cancer; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Salpingectomy

Concomitant salpingectomy at the time of hysterectomy for a benign reason

Group Type: EXPERIMENTAL

Salpingectomy

Intervention Type: PROCEDURE

The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.

No salpingectomy

No salpingectomy at the time of hysterectomy for a benign reason

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Salpingectomy

The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Planned hysterectomy for a benign reason
• Age < 55 years at randomization
• Willing to be randomized
• Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy.

Exclusion Criteria

• Previous bilateral oophorectomy and/or salpingectomy
• Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer))
• Non-understanding of the oral or written study information

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annika Strandell

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Annika Strandell, PI

Role: CONTACT

annika.strandell@vgregion.se

+46 700904454

Facility Contacts

Annika Strandell

Role: primary

annika.strandell@vgregion.se

700904454

References

Idahl A, Liv P, Darelius A, Collins E, Sundfeldt K, Palsson M, Strandell A. HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial. Trials. 2023 Mar 24;24(1):222. doi: 10.1186/s13063-023-07244-w.

Reference Type: DERIVED

PMID: 36959664 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VGFOUREG-650491

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LUA-HTA-2016:86

Identifier Type: -

Identifier Source: org_study_id