This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Fulvio Zullo, University Magna Graecia
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia Identifier:
First received: March 9, 2014
Last updated: November 17, 2016
Last verified: November 2016
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
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

Resource links provided by NLM:

Further study details as provided by Fulvio Zullo, University Magna Graecia:

Primary Outcome Measures:
  • 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:
  • Operative time [ Time Frame: The same day of surgery ]
    Time from skin incision to skin closure

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

Estimated Enrollment: 167
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 identifier: NCT02086344

Contact: Fulvio Zullo 39337947003

Chair of Obstetrics and Gynecology - University division - UMG Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo    39337947003   
Principal Investigator: Roberta Venturella, MD         
Sub-Investigator: Daniela Lico, MD         
Sponsors and Collaborators
University Magna Graecia
Study Director: Fulvio Zullo Magna Graecia University of Catanzaro
Principal Investigator: Roberta Venturella Magna Graecia University of Catanzaro
  More Information

Responsible Party: Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia Identifier: NCT02086344     History of Changes
Other Study ID Numbers: PBS_hysterectomy
Study First Received: March 9, 2014
Last Updated: November 17, 2016

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

Additional relevant MeSH terms:
Pelvic Pain
Pathological Conditions, Anatomical
Neurologic Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female processed this record on September 21, 2017