Pelvic Pain Clinical Trial
Official title:
The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer
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
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.
In fact, the carcinogenesis model proposed by Kurman, provides for the classification of the
most important histological types of epithelial tumors into two types, diversified according
to clinico-pathological and genetic features.
The type I is composed of low-grade serous, low-grade endometrioid, clear cell and mucinous
carcinomas, whose the ovarian borderline tumors and endometriosis represent the
pre-neoplastic lesions. Conversely, the II type includes high-grade endometrioid carcinomas,
carcinosarcomas and undifferentiated carcinomas and, more frequently, high-grade serous
carcinomas, whose preneoplastic lesion, now, seems to be represented by the serous tubal
intraepithelial carcinoma (STIC).
Plenty of evidence, to support the correlation between the epithelial ovarian cancer and the
STIC, has been obtained by immunohistochemical and molecular genetics investigations (11).
However, from a clinical point of view, this association has been demonstrated only by a
study on 55 patients affected by a high-grade serous carcinoma, whose results have shown an
involvement in the endosalpinx in 70% of cases and the presence of STIC in about 50% of
cases (12).
Some studies, performed on BRCA1 / 2 populations, showed the presence of strongly sites
reactive to p53, defined "p53 signature", in the distal tube (13). These sites seem to be
more frequent and characteristically multifocal in those tubes with concomitant STIC (14).
The finding of "p53 signature" may, therefore, identify an early clonal expansion of the
neoplastic proliferation.
This new theory has given the opportunity to prevent this devastating type of cancer by the
addition of the prophylactic bilateral salpingectomy (PBS, with the only removal of the tube
and the preservation of the ovaries) in all surgical procedures performed in those women
with benign diseases once they have accomplished their reproductive desire. The PBS, in
place of the current standard procedure (bilateral salpingo-oophorectomy) could reduce the
risk of cancer, improving at the same time the quality of life and reducing the risk of
premature death due to cardiovascular disease, seen in women subjected to
salpingo-oophorectomy before the onset of natural menopause.
Our preliminary data (17) show that, if the bilateral salpingectomy is performed with great
care, no patient has negative effects in terms of ovarian function. In addition, in our
experience, no perioperative complication is attributable to salpingectomy alone. Despite
the retrospective design of our first study, according to the post hoc analysis, these data
have shown a significant statistical reliability.
However, prospective data on the effetc of PBS in patients submitted to TLH are still needed
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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