Could bilateral salpingectomy reduce the risk of ovarian cancer?

procedure during which the fallopian tubes could be removed in addition to the primary surgical procedure. All data needed regarding the patient and the procedure will be collected in an online document and kept into the database of the department. The enrollment period will be from 1 st of June 2018 till May 30 th 2021. Outcomes. Before 1 st of August 2021 all the data must be collected and prepared for publication. The effectiveness of bilateral salpingectomy in the prevention of ovarian cancer will be evaluated according to multiple variables.


Introduction
Ovarian cancer has the poorest prognosis limited options in terms of early diagnosis and efficient treatment.There are no effective screening methods to prevent ovarian cancer in order to decrease mortality rate.
New theories in carcinogenesis suggest that ovarian high-grade serous carcinoma develops from the distal fallopian tube epithelium (1) .Recent literature data suggest that the majority of ovarian cancer lesions and pre-invasive lesions in both general population and BRCA1/BRCA2 mutation carriers develop from the fallopian fimbria and then spread to the ovary (2) .
Opportunistic bilateral salpingectomy during hysterectomy or other gynecological surgery has a minimal additional surgical risk to the patient.
For this reasons, in our clinic we adopted this prophylactic surgical procedure in patients eligible for hysterectomy to treat benign conditions, with no complication or intraoperative incidences.All the patients were counseled about the potential benefits of the removal of the fallopian tubes in order to decrease the risk of ovarian cancer.
Morelli et al. found no significant in operative time, hemoglobin level, hospital stay, return to normal activity or complication rate between the two groups comparing 79 patients who underwent total laparoscopic hysterectomy with bilateral salpingectomy with 79 women with the same operation but without bilateral salpingectomy (3) .
A larger long-term study is needed to assess the prophylactic role of opportunistic bilateral salpingectomy and its implications in ovarian cancer development.

Materials and method
We propose a national, multicenter, prospective, descriptive non-randomized interventional trial in order to evaluate the prophylactic role of opportunistic bilateral salpingectomy in reducing the risk of developing ovarian carcinoma.The aim of our multicenter trial is to analyze the potential use of bilateral salpingectomy as a primary preventive strategy of the ovarian cancer.
The study will be in accordance with the Committee on Publication Ethics guidelines and will be approved by the institutional review board of each hospital that will join the project.Each patient who will participate in this study will be well informed regarding the procedures and will sign a consent form for data collection for research purposes.An independent data safety and monitoring committee will evaluate the results of the study.
All women candidates for different surgical gynecological interventions for benign reasons (hysterectomy, ovarian cystectomy, tubal ligation) or caesarean section, with requested voluntary tubal ligation, will be enrolled after a previous counseling with the potential benefits and fertility consequence of the method.After bilateral salpingectomy, all women will perform clinical and transvaginal ultrasound examination annually for 3 consecutive years.
All data regarding the patient and the procedure will be collected in a document in the D-Base designed for this purpose.
We will exclude from the enrollment women with malignant and borderline diseases, even in cases when the diagnosis was established intraoperatively or later (histopathological specimen).Also, will be excluded patients that do not agree to sign the informed consent.The enrollment period will start on the 1 st of June 2018 till 30 th of May 2021.

Outcomes
Before the end of July 2021 all the data must be collected and prepared for publication.The effectiveness of bilateral salpingectomy in the prevention of ovarian cancer will be evaluated according to multiple variables taken into consideration.
High-grade serous ovarian carcinoma is the most common and aggressive subtype, with poor prognosis and low survival rate (7) .
In 2015, Venturella et al. concluded that prophylactic bilateral salpingectomy did not impair the ovarian reserve, with no postoperative effect in ovarian volume, nor on the AMH (anti-müllerian hormone) and FSH (follicle stimulating hormone) levels (8) .The study of Morelli et al. compared the complication rates for bilateral salpingectomy versus no salpingectomy in women who underwent total laparoscopic hysterectomy, and ended up indicating that there were no differences between the two groups (3) .
Morelli et al. found no significant difference in operative time, hemoglobin level, hospital stay, return to normal activity or complication rate between the two groups comparing 79 patients who underwent total laparoscopic hysterectomy with bilateral salpingectomy with 79 women with the same operation but without bilateral salpingectomy (3) .
To our knowledge, there are poor clinical and epidemiological data about ovarian cancer prevention and screening, and the prophylactic bilateral salpingectomy remains an accessible method with minimal risks that could be sustained by gynecologists.
However, opportunistic bilateral salpingectomy in the prevention of ovarian cancer is a patient's decision, based on her own pReferences.In order to maximize the patient's benefits and minimize risks, it is absolutely necessary to support the patient in taking decisions.Another option in the prevention of ovarian cancer ginecologie ro ginecologia would bilateral salpingectomy in high-risk population in order to maximize their benefit (9) .
Traditionally, the ovarian tissue was regarded as the most common primary site of carcinogenesis, but the new studies suggest that this process starts in the distal fimbria and then spread to the ovary.According to the new theories, we can consider the epithelial carcinoma of the ovary, the fallopian tubes and peritoneum as a single entity (2) .
For accurate data, we need long-term studies to determine the efficacy of opportunistic bilateral salpingectomy for ovarian cancer prevention.n