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临床试验/NCT02086370
NCT02086370已完成不适用

Prophylactic Salpingectomy for the Prevention of the Ovarian Cancer: Comparison Between Surgical Techniques. A Randomized Controlled Trial

University Magna Graecia2 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
177
试验地点
2
主要终点
Ovarian reserve change

研究概览

简要总结

The aim of this RCT of study is to compare the outcomes of the standard salpingectomy (removal of the fallopian tube) with the radical removal of the tube and the mesosalpinx in terms of ovarian reserve.

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
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients subjected to a laparoscopic surgery for a benign gynecologic disease or who require tubal surgical sterilization, once they have accomplished their reproductive desire, and after the acquisition of a written consent for prophylactic salpingectomy and the ovarian preservation.
  • Age between 35 and 50 years
  • Regular menstruation with intervals between 22 and 35 days

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
  • Patients subjected to hysterectomy
  • 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 change

时间窗: One, and 3 months after surgery

The basal levels of AMH, FSH and estradiol, the antral follicle count (AFC), the ovarian volume, the Vascularization Index (VI), the flow index (FI) and the 'vascular flow index (VFI) in all healthy women over a period of time between the first and fourth day of their menstrual cycle will be assessed.

次要结局

  • Operative times(The same day of surgery)
  • Intraoperative blood loss(two hours after the end of surgery)
  • postoperative hospital stay(The day of patient discharge, everage 4 day after surgery)
  • return to the normal activities(two month after surgery)
  • complication rate(The day of patient discharge, everage 4 day after surgery)

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fulvio Zullo

Full Professor Obstetric Gynecology

University Magna Graecia

研究点 (2)

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