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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT02086370
First received: March 9, 2014
Last updated: April 19, 2015
Last verified: April 2015
  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
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 Fulvio Zullo, University Magna Graecia:

Primary Outcome Measures:
  • Ovarian reserve change [ Time Frame: One, and 3 months after surgery ]
    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 ]
  • Intraoperative blood loss [ Time Frame: two hours after the end of surgery ]
  • postoperative hospital stay [ Time Frame: The day of patient discharge, everage 4 day after surgery ]
  • return to the normal activities [ Time Frame: two month after surgery ]
  • complication rate [ Time Frame: The day of patient discharge, everage 4 day after surgery ]

Enrollment: 177
Study Start Date: March 2014
Study Completion Date: April 2015
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   (Adult)
Sexes 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 35 and 50 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

Locations
Italy
Chair of Obstetrics and Gynecology - University division - UMG
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Fulvio Zullo Magna Graecia University of Catanzaro
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 19, 2015

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

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

ClinicalTrials.gov processed this record on June 23, 2017