Hysterectomy and OPPortunistic SAlpingectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hysterectomy and Opportunistic Salpingectomy

Conditions
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Ovarian Cancer, Complication

Intervention / Treatment
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* Procedure: Salpingectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingectomy<br>Concomitant salpingectomy at the time of hysterectomy for a benign reason | Procedure: Salpingectomy<br>* The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.<br>|
| No Intervention: No salpingectomy<br>No salpingectomy at the time of hysterectomy for a benign reason | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 10-30 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Continous outcome, registered in minutes | At day of surgery | 
| Length of hospital stay | Continous outcome, registered in days | 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 | At day of surgery | 
| Conversion to other surgical route | Dichotomous outcome | At day of surgery | 
| Failure rate of salpingectomy at planned vaginal hysterectomy | Dichotomous outcome | At day of surgery | 
| Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS) | Dichotomous outcome based on MRS | One and five years after surgery | 
| Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline | Continous outcome, measured in mg/L | One year after surgery | 
| Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries | Dichotomous outcome, accompanied by a description of number and types of surgery performed | At one and up to ten years after surgery | 
| Use of Hormone Replacement Therapy (HRT) | Dichotomous outcome | At one and up to ten years after surgery | 
| Cardiovascular disease | Dichotomous outcome, accompanied by the specific ICD diagnoses | 10-30 years after surgery | 
| Fractures (primarily radial, vertebral and hip fractures) | Dichotomous outcome, accompanied by the specific ICD diagnoses | 10-30 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salpingectomy, Hysterectomy, Ovarian cancer