Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

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:
NCT02086344
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 standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes


Condition Intervention
Uterine Fibroids
Adenomyosis
Pelvic Pain
Pelvic Prolapse
Procedure: PBS
Procedure: TLH _adnexal preservation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Ovarian reserve modification [ Time Frame: Three months after laparoscopy ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Operative time [ Time Frame: The same day of surgery ] [ Designated as safety issue: Yes ]
    Time from skin incision to skin closure

  • variation of hemoglobin level [ Time Frame: two hours after the end of surgery ] [ Designated as safety issue: Yes ]
  • postoperative hospital stay [ Time Frame: The day of patient discharge ] [ Designated as safety issue: Yes ]
  • postoperative return to normal activity [ Time Frame: two months after surgery ] [ Designated as safety issue: No ]
  • complication rate [ Time Frame: The day of patient discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 167
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLH_plus_PBS
TLH plus PBS
Procedure: PBS
TLH plus PBS
Other Name: Bilateral Salpingectomy
Active Comparator: TLH _adnexal preservation
Standard TLH without PBS
Procedure: TLH _adnexal preservation
TLH without PBS
Other Name: Standard TLH without salpingectomy

  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:

  • Indication to laparoscopic hysterectomy
  • Accomplished reproductive desire

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
  • 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: NCT02086344

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         
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: NCT02086344     History of Changes
Other Study ID Numbers: PBS_hysterectomy
Study First Received: March 9, 2014
Last Updated: March 11, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Total Laparoscopic Hysterectomy
TLH
Ovarian reserve
Prophylactic bilateral salpingectomy
Ovarian cancer prevention
Ovarian cancer
Fallopian Tubes

Additional relevant MeSH terms:
Pelvic Pain
Adenomyosis
Leiomyoma
Myofibroma
Connective Tissue Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Pain
Signs and Symptoms
Uterine Diseases

ClinicalTrials.gov processed this record on October 23, 2014