Abnormal Uterine Bleeding, Unspecified Clinical Trial
Official title:
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02059954 -
Vaginal vs. Laparoscopic Hysterectomy
|
N/A | |
| Terminated |
NCT01963403 -
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
|
Phase 4 |