Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

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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