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Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086344
Recruitment Status : Unknown
Verified November 2016 by Fulvio Zullo, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Fibroids Adenomyosis Pelvic Pain Pelvic Prolapse Procedure: PBS Procedure: TLH _adnexal preservation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Ovarian reserve modification [ Time Frame: Three months after laparoscopy ]
    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 :
  1. Operative time [ Time Frame: The same day of surgery ]
    Time from skin incision to skin closure

  2. variation of hemoglobin level [ Time Frame: two hours after the end of surgery ]
  3. postoperative hospital stay [ Time Frame: The day of patient discharge ]
  4. postoperative return to normal activity [ Time Frame: two months after surgery ]
  5. complication rate [ Time Frame: The day of patient discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086344


Contacts
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Contact: Fulvio Zullo 39337947003 zullo@unicz.it

Locations
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Italy
Chair of Obstetrics and Gynecology - University division - UMG Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo    39337947003    zullo@unicz.it   
Principal Investigator: Roberta Venturella, MD         
Sub-Investigator: Daniela Lico, MD         
Sponsors and Collaborators
University Magna Graecia
Investigators
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Study Director: Fulvio Zullo Magna Graecia University of Catanzaro
Principal Investigator: Roberta Venturella Magna Graecia University of Catanzaro
Publications:
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Responsible Party: Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02086344    
Other Study ID Numbers: PBS_hysterectomy
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Fulvio Zullo, University Magna Graecia:
Total Laparoscopic Hysterectomy
TLH
Ovarian reserve
Prophylactic bilateral salpingectomy
Ovarian cancer prevention
Ovarian cancer
Fallopian Tubes
Additional relevant MeSH terms:
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Leiomyoma
Adenomyosis
Prolapse
Pelvic Pain
Pathological Conditions, Anatomical
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pain
Neurologic Manifestations
Uterine Diseases