Brief Title
Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy
Official Title
The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer
Brief Summary
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
Detailed Description
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
Study Type
Interventional
Primary Outcome
Ovarian reserve modification
Secondary Outcome
Operative time
Condition
Uterine Fibroids
Intervention
PBS
Study Arms / Comparison Groups
TLH_plus_PBS
Description: TLH plus PBS
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
167
Start Date
February 2014
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria:
- Indication to laparoscopic hysterectomy
- Accomplished reproductive desire
Exclusion Criteria:
- 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
- PCOS
- 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
Gender
Female
Ages
35 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Fulvio Zullo, 39337947003, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT02086344
Organization ID
PBS_hysterectomy
Responsible Party
Principal Investigator
Study Sponsor
University Magna Graecia
Study Sponsor
Fulvio Zullo, Study Director, Magna Graecia University of Catanzaro
Verification Date
November 2016