Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
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.
|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|
- 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 ]
- 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.
|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)|
Experimental: Salpingectomy group
Participants in this group will have their fallopian tubes removed.
Removal of the fallopian tubes
No Intervention: No Salpingectomy Group
Participants in this group will not have their fallopian tubes removed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578759
|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|
|Principal Investigator:||Austin Findley, MD||University of North Carolina, Chapel Hill|