Hysterectomy and OPPortunistic SAlpingectomy

N/AActive Not RecruitingNCT03045965

Göteborg University4,400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

4,400

Conditions

Ovarian Cancer Complication

Interventions

SalpingectomyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 54 Years

Medical Language ↔ Plain English

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

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

Surgical complication - short term primary outcome

Dichotomous outcome, retrieved from any of two sources in the GynOp register: specified question on complications and the Clavien-Dindo classification

Time frame: Eight weeks post-operative

Change in menopausal symptom score - intermediate term primary outcome

Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)

Time frame: One year after surgery

Epithelial ovarian cancer - long term primary outcome

The outcome is dichotomous, the diagnosis is classified according to ICD10. Each case with a positive outcome is further described with histopathological types and grade, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers

Time frame: 10-30 years after surgery

Secondary Outcomes

Operative time

Continous outcome, registered in minutes

Time frame: At day of surgery

Length of hospital stay

Continous outcome, registered in days

Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a

Perioperative blood loss

Continous outcome, registered in ml

Time frame: At day of surgery

Conversion to other surgical route

Dichotomous outcome

Data from ClinicalTrials.gov

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