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Uterine FibroidsNCT02086344

Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

A study testing PBS and TLH _adnexal preservation in people with Uterine Fibroids and Adenomyosis, run by University Magna Graecia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 35 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Uterine Fibroids, Adenomyosis, Pelvic Pain
What is being tested?
PBS and TLH _adnexal preservation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteItaly
Study dates
Feb 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Indication to laparoscopic hysterectomy
  • Accomplished reproductive desire

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Fulvio Zullo contact

39337947003

zullo@unicz.it

Italy1 site, 1 recruiting
  • Chair of Obstetrics and Gynecology - University division - UMG

    Catanzaro, CZ, 88100

    Fulvio Zullo, 39337947003, zullo@unicz.it

    Roberta Venturella, MD

    Recruiting

Other trials in Italy

About this study

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

Read the 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

Being tested
PBS, TLH _adnexal preservation
Keywords
Total Laparoscopic Hysterectomy, TLH, Ovarian reserve, Prophylactic bilateral salpingectomy, Ovarian cancer prevention, Ovarian cancer, Fallopian Tubes
Medical subject headings
Leiomyoma, Adenomyosis, Pelvic Pain, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBSProcedure or surgery

    Also called Bilateral Salpingectomy

    TLH plus PBS

  • TLH _adnexal preservationProcedure or surgery

    Also called Standard TLH without salpingectomy

    TLH without PBS

Study groups in NCT02086344
Study groupRoleWhat they receive
TLH_plus_PBSExperimentalTLH plus PBS
Receives: Procedure: PBS
TLH _adnexal preservationActive comparatorStandard TLH without PBS
Receives: Procedure: TLH _adnexal preservation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ovarian reserve modification

    Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI

    Measured: Three months after laparoscopy

Secondary outcomes (5)
  1. Operative time

    Time from skin incision to skin closure

    Measured: The same day of surgery

  2. variation of hemoglobin level

    Measured: two hours after the end of surgery

  3. postoperative hospital stay

    Measured: The day of patient discharge

  4. postoperative return to normal activity

    Measured: two months after surgery

  5. complication rate

    Measured: The day of patient discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086344
Sponsor's protocol ID
PBS_hysterectomy
Status last verified
Nov 2016
First submitted
9 Mar 2014
Last updated
18 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2.

    PubMed 23558052

Questions about this trial

What is this clinical trial studying?

A study testing PBS and TLH _adnexal preservation in people with Uterine Fibroids and Adenomyosis, run by University Magna Graecia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fulvio Zullo (39337947003, zullo@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ovarian reserve modification (time frame: Three months after laparoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02086344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.

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