Clinical trial NCT03045965: Hysterectomy and OPPortunistic SAlpingectomy
Official title: Hysterectomy and Opportunistic Salpingectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Complication
Keywords: Salpingectomy
Hysterectomy
Ovarian cancer
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Umeå University
First posted: 2017-02-08
Enrollment: 4400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical complication - short term primary outcome
timeFrame: Eight weeks post-operative
measure: Change in menopausal symptom score - intermediate term primary outcome
timeFrame: One year after surgery
measure: Epithelial ovarian cancer - long term primary outcome
timeFrame: 10-30 years after surgery
Secondary outcomes:
measure: Operative time
timeFrame: At day of surgery
measure: Length of hospital stay
timeFrame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a
measure: Perioperative blood loss
timeFrame: At day of surgery
measure: Conversion to other surgical route
timeFrame: At day of surgery
measure: Failure rate of salpingectomy at planned vaginal hysterectomy
timeFrame: At day of surgery
measure: Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)
timeFrame: One and five years after surgery
measure: Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline
timeFrame: One year after surgery
measure: Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries
timeFrame: At one and up to ten years after surgery
measure: Use of Hormone Replacement Therapy (HRT)
timeFrame: At one and up to ten years after surgery
measure: Cardiovascular disease
timeFrame: 10-30 years after surgery
measure: Fractures (primarily radial, vertebral and hip fractures)
timeFrame: 10-30 years after surgery
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Annika Strandell
role: PRINCIPAL_INVESTIGATOR
References: