Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01929148
• Other study ID #: PBS_myomectomy
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2013
• Last updated: November 17, 2016
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding, Unspecified
• Uterine Hemorrhage

Intervention

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
• Laparoscopic myomectomy without PBS
Standard laparoscopic myomectomy without salpingectomy

Locations

Country	Name	City	State
Italy	Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio	Catanzaro	CZ

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve modification	Ovarian reserve modification will be defined as the difference (expressed as ?) 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	Yes
Secondary	Surgical outcomes	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	Yes