SALpingectomy for STERilization (SALSTER); a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.
详细描述
SALSTER Study
In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation.
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited.
In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited.
The study is expected to start in the beginning of 2019 and the first results are expected in 2021.
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
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planned laparoscopic sterilization
- •Willing to be randomized
排除标准
- •Women older than 49
- •Not understanding the oral or written study information
- •Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function
结局指标
主要结局
Complications
时间窗: Eight weeks post-operatively
Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data.
Age at menopause
时间窗: Twenty years
Determined from questionnaires on bleeding pattern in GynOp. Continuous data.
次要结局
- Severe complications(Eight weeks post-operatively)
- 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)
- Complications according to Clavien-Dindo(One year after surgery)
- Age at the start of the perimenopausal state(Up to 55 years of age)
- Use of hormone replacement therapy at any time during follow-up(Up to 55 years of age)
- Perioperative blood loss(At day of surgery)
- Complications(One year after surgery)
- Length of the perimenopausal state(Up to 55 years of age)
- Epithelial ovarian cancer including histopathological types and grade, primary tubal and peritoneal cancer, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO)(40 years)
- Secondary expressions of estrogen deficiency(40 years)
- Change in menopausal symptom score(Up to 55 years of age)
- Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.(At one year and up to 55 years of age)
- Pregnancy(At one year and up to 55 years of age)