Laparoscopic Hysterectomy Clinical Trial
Official title:
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Verified date | October 2014 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) | AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1. | ||
Secondary | Patient demographics | The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication. | Prior to surgery | |
Secondary | Patient surgical outcomes | The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology. | Postoperatively on day 1 |
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