Hysterectomy and OPPortunistic SAlpingectomy (HOPPSA)

Göteborg University

Status

Enrolling

Conditions

Complication

Ovarian Cancer

Treatments

Procedure: Salpingectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03045965

LUA-HTA-2016:86

VGFOUREG-650491 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,400 estimated patients

Sex

Female

Ages

20 to 54 years old

Volunteers

No Healthy Volunteers

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