Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy

NCT01929148 | Unknown DMC

• 1 other identifier: PBS_myomectomy
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding, Unspecified

Keywords

risk-reducing salpingectomy; prophylactic bilateral salpingectomy; ovarian cancer prevention; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve modification

  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)

  three months after laparoscopy

Secondary Outcomes (1)

• Surgical outcomes

  one day to one month after laparoscopy

Study Arms (2)

Laparoscopic myomectomy plus PBS

EXPERIMENTAL

A Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire

Procedure: Prophylactic bilateral salpingectomy

Laparoscopic myomectomy without PBS

ACTIVE COMPARATOR

A standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed

Procedure: Laparoscopic myomectomy without PBS

Interventions

Prophylactic bilateral salpingectomy PROCEDURE

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

Also known as: PBS, bilateral salpingectomy

Laparoscopic myomectomy plus PBS

Laparoscopic myomectomy without PBS PROCEDURE

Standard laparoscopic myomectomy without salpingectomy

Also known as: LM

Laparoscopic myomectomy without PBS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Indication to laparoscopic myomectomy
• Accomplished reproductive desire

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, CZ, 88100, Italy

RECRUITING

Related 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. Epub 2013 Apr 2.

  PMID: 23558052 BACKGROUND

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fulvio Zullo, Md, PhD

  Magna Graecia University of Catanzaro

  STUDY DIRECTOR

• Roberta Venturella

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

IT (1)