Prophylactic Salpingectomy for the Prevention of the Ovarian Cancer: Comparison Between Surgical Techniques

NCT02086370 | Completed DMC

• 1 other identifier: Radical_PBS
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this RCT of study is to compare the outcomes of the standard salpingectomy (removal of the fallopian tube) with the radical removal of the tube and the mesosalpinx in terms of ovarian reserve.

Conditions

Uterine Fibroids; Contraception Desired

Keywords

PBS; Prophylactic bilateral salpingectomy; Ovarian cancer prevention; Ovarian reserve; Permanent contraception; Surgical sterilization

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve change

  The basal levels of AMH, FSH and estradiol, the antral follicle count (AFC), the ovarian volume, the Vascularization Index (VI), the flow index (FI) and the 'vascular flow index (VFI) in all healthy women over a period of time between the first and fourth day of their menstrual cycle will be assessed.

  One, and 3 months after surgery

Secondary Outcomes (5)

• Operative times

  The same day of surgery

• Intraoperative blood loss

  two hours after the end of surgery

• postoperative hospital stay

  The day of patient discharge, everage 4 day after surgery

• return to the normal activities

  two month after surgery

• complication rate

  The day of patient discharge, everage 4 day after surgery

Study Arms (2)

Standard PBS

ACTIVE COMPARATOR

the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of the posterior tubal margin, sparing the mesosalpinx

Procedure: Standard PBS

Radical PBS

EXPERIMENTAL

the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of ovarian margin and the uterus-ovarian ligament, including the mesosalpinx removal

Procedure: Radical PBS

Interventions

Standard PBS PROCEDURE

the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of the posterior tubal margin, sparing the mesosalpinx.

Standard PBS

Radical PBS PROCEDURE

the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of ovarian margin and the uterus-ovarian ligament, including the mesosalpinx removal.

Radical PBS

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients subjected to a laparoscopic surgery for a benign gynecologic disease or who require tubal surgical sterilization, once they have accomplished their reproductive desire, and after the acquisition of a written consent for prophylactic salpingectomy and the ovarian preservation.
• Age between 35 and 50 years
• Regular menstruation with intervals between 22 and 35 days

You may not qualify if:

• Patients with a family history of ovarian cancer and with a known mutation of the BRCA1/2 genes
• Patients with a current or a past history of cancer
• Patients who don't consent to the prophylactic salpingectomy
• Patients subjected to hysterectomy
• Previous adnexal surgery
• PCOS
• Estrogen-progestin therapy in the 2 months prior to the enrollment
• Acute or chronic pelvic inflammatory disorders
• Malignant gynecological neoplasms
• Prior chemotherapy or radiotherapy
• Autoimmune diseases, chronic, metabolic, endocrine and systemic disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease
• Hypogonadotropic hypogonadism
• Taking medications that can cause menstrual irregularities
• Other clinical conditions

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

Location

Related Publications (2)

• 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

• Venturella R, Morelli M, Lico D, Di Cello A, Rocca M, Sacchinelli A, Mocciaro R, D'Alessandro P, Maiorana A, Gizzo S, Zullo F. Wide excision of soft tissues adjacent to the ovary and fallopian tube does not impair the ovarian reserve in women undergoing prophylactic bilateral salpingectomy: results from a randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1332-9. doi: 10.1016/j.fertnstert.2015.08.004. Epub 2015 Aug 31.

  PMID: 26335129 DERIVED

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Fulvio Zullo

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetric Gynecology

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

IT (1)