Hysterectomy and Opportunistic Salpingectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- Epithelial ovarian cancer - long term primary outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Masking of the intervention is planned to include the one-year follow-up of menopausal symptoms.
入排标准
- 年龄范围
- 20 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Salpingectomy
Concomitant salpingectomy at the time of hysterectomy for a benign reason
干预措施: Salpingectomy (Procedure)
No salpingectomy
No salpingectomy at the time of hysterectomy for a benign reason
结局指标
主要结局
Epithelial ovarian cancer - long term primary outcome
时间窗: 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
Surgical complication - short term primary outcome
时间窗: 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
时间窗: One year after surgery
Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)
次要结局
- Operative time(At day of surgery)
- Length of hospital stay(Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a)
- Perioperative blood loss(At day of surgery)
- Conversion to other surgical route(At day of surgery)
- Failure rate of salpingectomy at planned vaginal hysterectomy(At day of surgery)
- Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)(One and five years after surgery)
- Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline(One year after surgery)
- Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries(At one and up to ten years after surgery)
- Fractures (primarily radial, vertebral and hip fractures)(10-30 years after surgery)
- Use of Hormone Replacement Therapy (HRT)(At one and up to ten years after surgery)
- Cardiovascular disease(10-30 years after surgery)