Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01929148
First received: August 21, 2013
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Abnormal Uterine Bleeding, Unspecified
Procedure: Prophylactic bilateral salpingectomy
Procedure: Laparoscopic myomectomy without PBS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Ovarian reserve modification [ Time Frame: three months after laparoscopy ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Surgical outcomes [ Time Frame: one day to one month after laparoscopy ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 154
Study Start Date: August 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: LM

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929148

Locations
Italy
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo, MD, PhD    39337947003    zullo@unicz.it   
Principal Investigator: Fulvio Zullo, MD, PhD         
Sub-Investigator: Roberta Venturella         
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Fulvio Zullo, Md, PhD Magna Graecia University of Catanzaro
  More Information

Publications:
Responsible Party: Fulvio Zullo, Full Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01929148     History of Changes
Other Study ID Numbers: PBS_myomectomy
Study First Received: August 21, 2013
Last Updated: March 15, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University Magna Graecia:
risk-reducing salpingectomy
prophylactic bilateral salpingectomy
ovarian cancer prevention
ovarian reserve

Additional relevant MeSH terms:
Uterine Hemorrhage
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Uterine Diseases

ClinicalTrials.gov processed this record on October 23, 2014