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Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Austin Findley, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01578759
First received: April 11, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.


Condition Intervention
Laparoscopic Hysterectomy
 Procedure: Salpingectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) [ Time Frame: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient demographics [ Time Frame: Prior to surgery ] [ Designated as safety issue: No ]
    The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.

  • Patient surgical outcomes [ Time Frame: Postoperatively on day 1 ] [ Designated as safety issue: No ]
    The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salpingectomy group
Participants in this group will have their fallopian tubes removed.
 Procedure: Salpingectomy
Removal of the fallopian tubes
No Intervention: No Salpingectomy Group
Participants in this group will not have their fallopian tubes removed.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

Exclusion Criteria:

  • Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
  • Personal history of gynecologic cancer
  • Pregnancy
  • Non-English speaking
  • Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578759

Locations
United States, North Carolina
Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Austin Findley, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Austin Findley, MD, Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01578759     History of Changes
Other Study ID Numbers: 12-0440
Study First Received: April 11, 2012
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
ovarian function tests

ClinicalTrials.gov processed this record on June 17, 2013