Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy

November 17, 2016 updated by: Fulvio Zullo, University Magna Graecia

Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?

We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative hospital stay, postoperative return to normal activity and complication rate) are related to PBS step in TLH.

Although the good statistical reliability of our retrospective data, we want to prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic parameters may possibly be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG Department) able to estimate the ovarian function both in term of reproductive ability that in term of distance from menopause.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We will enroll the first 77 patients who will agree to implement PBS to laparoscopic myomectomy (LM) (study group), starting from September 1, 2013. Other 77 patients who will ask us to undergo LM without the addiction of PBS will constitute the control group. For each patient, ovarian reserve modification before and after surgery will be recorded as the primary outcome. Specifically, one month before and three months after laparoscopy, on day 1 to 4 of menstrual cycles serum AMH, FSH and E2 will be evaluated and a transvaginal ultrasound examination (Voluson E8 Expert or Voluson-i - GE Healthcare Ultrasound) to assess AFC, OV, VI, FI and VFI, will be carried out by the same experienced ultrasonographist responsible for the ambulatory of ovarian reserve in each Unit.

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. For each surgical procedure, moreover, operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Recruiting
        • Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
        • Principal Investigator:
          • Roberta Venturella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Indication to laparoscopic myomectomy
  • Accomplished reproductive desire

Exclusion Criteria:

  • Age older than 50 years
  • family history of ovarian cancer, BRCA positive
  • basal FSH value of >20 IU/mL and/or E2 levels >60 pg/mL
  • presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months >20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic myomectomy plus PBS
A Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire
Procedure: Prophylactic bilateral salpingectomy
Salpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu
Other Names:
  • PBS, bilateral salpingectomy
ACTIVE_COMPARATOR: Laparoscopic myomectomy without PBS
A standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed
Procedure: Laparoscopic myomectomy without PBS
Standard laparoscopic myomectomy without salpingectomy
Other Names:
  • LM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian reserve modification
Time Frame: three months after laparoscopy
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), Ovarian volume (OV), Vascularization Index (VI), Flow index (FI) and Vascularization Flow Index (VFI)
three months after laparoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical outcomes
Time Frame: one day to one month after laparoscopy
For each surgical procedure operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.
one day to one month after laparoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Investigators

  • Study Director: Fulvio Zullo, Md, PhD, Magna Graecia University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (ESTIMATE)

August 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBS_myomectomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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