Trial record 5 of 12 for:    Open Studies | "Sterilization, Reproductive"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT02086370
First received: March 9, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Uterine Fibroids
Contraception Desired
Procedure: Standard PBS
Procedure: Radical PBS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Salpingectomy for the Prevention of the Ovarian Cancer: Comparison Between Surgical Techniques. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Ovarian reserve change [ Time Frame: One, 6 and 12 months after surgery ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Operative times [ Time Frame: The same day of surgery ] [ Designated as safety issue: No ]
  • Intraoperative blood loss [ Time Frame: two hours after the end of surgery ] [ Designated as safety issue: Yes ]
  • postoperative hospital stay [ Time Frame: The day of patient discharge, everage 4 day after surgery ] [ Designated as safety issue: No ]
  • return to the normal activities [ Time Frame: two month after surgery ] [ Designated as safety issue: No ]
  • complication rate [ Time Frame: The day of patient discharge, everage 4 day after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: January 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard PBS
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
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.
Experimental: Radical PBS
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 18 and 40 years
  • Regular menstruation with intervals between 22 and 35 days

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086370

Contacts
Contact: Fulvio Zullo 39337947003 zullo@unicz.it

Locations
Italy
Chair of Obstetrics and Gynecology - University division - UMG Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo    39337947003    zullo@unicz.it   
Sub-Investigator: Roberta Venturella, MD         
Sub-Investigator: Daniela Lico, MD         
Sub-Investigator: Michele Morelli, MD, PhD         
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Fulvio Zullo Magna Graecia University of Catanzaro
  More Information

Publications:
Responsible Party: Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02086370     History of Changes
Other Study ID Numbers: Radical_PBS
Study First Received: March 9, 2014
Last Updated: March 11, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
PBS
Prophylactic bilateral salpingectomy
Ovarian cancer prevention
Ovarian reserve
Permanent contraception
Surgical sterilization

Additional relevant MeSH terms:
Leiomyoma
Ovarian Neoplasms
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014