Complication, Ovarian Cancer
Conditions
Keywords
Salpingectomy, Hysterectomy, Ovarian cancer
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.
Interventions
PROCEDURESalpingectomy
The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.
Sponsors
Göteborg University
Vastra Gotaland Region
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Masking of the intervention is planned to include the one-year follow-up of menopausal symptoms.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 54 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complication - short term primary outcome | Eight weeks post-operative | Dichotomous outcome, retrieved from any of two sources in the GynOp register: specified question on complications and the Clavien-Dindo classification |
| Change in menopausal symptom score - intermediate term primary outcome | One year after surgery | Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS) |
| Epithelial ovarian cancer - long term primary outcome | 10-30 years after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | At day of surgery | Continous outcome, registered in minutes |
| Length of hospital stay | Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a | Continous outcome, registered in days |
| Perioperative blood loss | At day of surgery | Continous outcome, registered in ml |
| Conversion to other surgical route | At day of surgery | Dichotomous outcome |
| Failure rate of salpingectomy at planned vaginal hysterectomy | At day of surgery | Dichotomous outcome |
| Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS) | One and five years after surgery | Dichotomous outcome based on MRS |
| Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline | One year after surgery | Continous outcome, measured in mg/L |
| Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries | At one and up to ten years after surgery | Dichotomous outcome, accompanied by a description of number and types of surgery performed |
| Use of Hormone Replacement Therapy (HRT) | At one and up to ten years after surgery | Dichotomous outcome |
| Cardiovascular disease | 10-30 years after surgery | Dichotomous outcome, accompanied by the specific ICD diagnoses |
| Fractures (primarily radial, vertebral and hip fractures) | 10-30 years after surgery | Dichotomous outcome, accompanied by the specific ICD diagnoses |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORAnnika Strandell
Sahlgrenska University Hospital
Outcome results
None listed