Clinical trial NCT01929148: Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
Official title: Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Uterine Bleeding, Unspecified
Keywords: risk-reducing salpingectomy
prophylactic bilateral salpingectomy
ovarian cancer prevention
ovarian reserve
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Ovarian reserve modification
timeFrame: three months after laparoscopy
Secondary outcomes:
measure: Surgical outcomes
timeFrame: one day to one month after laparoscopy
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
state: CZ
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Fulvio Zullo, Md, PhD
role: STUDY_DIRECTOR
affiliation: Magna Graecia University of Catanzaro
name: Roberta Venturella
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.