Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
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|ClinicalTrials.gov Identifier: NCT01929148|
Recruitment Status : Recruiting
First Posted : August 27, 2013
Last Update Posted : November 18, 2016
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 or disease||Intervention/treatment|
|Abnormal Uterine Bleeding, Unspecified||Procedure: Prophylactic bilateral salpingectomy Procedure: Laparoscopic myomectomy without PBS|
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 (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929148
|Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio||Recruiting|
|Catanzaro, CZ, Italy, 88100|
|Contact: Fulvio Zullo, MD, PhD 39337947003 firstname.lastname@example.org|
|Principal Investigator: Roberta Venturella|
|Study Director:||Fulvio Zullo, Md, PhD||Magna Graecia University of Catanzaro|
|Principal Investigator:||Roberta Venturella||Magna Graecia University of Catanzaro|