The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Ovarian reserve modification
研究概览
简要总结
The aim of this RCT of study is to compare the standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes
详细描述
Ovarian cancer accounts for 3% of all female cancers and represents the fifth leading cause of cancer death in the Western world (1). In 90% of cases, these are epithelial ovarian cancers (2).
Because of the biological aggressiveness of this tumor and nonspecific symptoms, that causes a diagnosis at an advanced stage in 75% of cases, ovarian cancer is the gynecological cancer with the highest mortality rate (3).
To date, an effective screening strategy to the early diagnosis of ovarian cancer doesn't exist, so the prophylactic adnexectomy is the only available tool to reduce the incidence and the mortality rate, even if the role of this surgical strategy is controversial, especially in premenopausal women (4). In fact, the American College of Obstetricians and Gynaecologists (ACOG) guidelines recommend the ovarian preservation in premenopausal women with no family history or other risk factors for ovarian cancer (5).
Some clinical studies have shown that the prophylactic adnexectomy and the consequent surgical menopause increase significantly the long term risk of cardiovascular and psychosexual diseases. (6-8). In particular, a case-control study done in a population of 29,380 women subjected to hysterectomy with and without adnexectomy, showed an increased risk of total mortality ( HRs 1.12 95 % CI 1:03 to 1:21 ), lethal and non- lethal cardiovascular disease ( HRs 1.17 95 % CI 1:02 to 1:35 ) and stroke ( HRs 1.14 95 % CI 0.98-1.33 ) (9) . In this population of women subjected to salpingectomy, the surgery wasn't able to lead to an improvement in general survival (10).
Considering the new histopathological classification of the epithelial ovarian cancer, proposed by Kurman (11) and based on new acquisitions about the pathogenesis and the origin of these tumors, it is possible to conceive a new preventive strategy associated with a less morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication to laparoscopic hysterectomy
- •Accomplished reproductive desire
排除标准
- •Patients with a family history of ovarian cancer and with a known mutation of the BRCA1/2 genes
- •Patients with a current or a past history of cancer
- •Patients who don't consent to the prophylactic salpingectomy
- •Previous adnexal surgery
- •Estrogen-progestin therapy in the 2 months prior to the enrollment
- •Acute or chronic pelvic inflammatory disorders
- •Malignant gynecological neoplasms
- •Prior chemotherapy or radiotherapy
- •Autoimmune diseases, chronic, metabolic, endocrine and systemic disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease
- •Hypogonadotropic hypogonadism
- •Taking medications that can cause menstrual irregularities
- •Other clinical conditions
结局指标
主要结局
Ovarian reserve modification
时间窗: Three months after laparoscopy
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI
次要结局
- postoperative return to normal activity(two months after surgery)
- Operative time(The same day of surgery)
- variation of hemoglobin level(two hours after the end of surgery)
- postoperative hospital stay(The day of patient discharge)
- complication rate(The day of patient discharge)
研究者
Fulvio Zullo
Full Professor Obstetric Gynecology
University Magna Graecia
