Hysterectomy, Oophorectomy
Conditions
Brief summary
This is a pilot study to assess the feasibility of conducting a randomized, blinded, controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to group assignment. The primary goal of this pilot is to determine the feasibility of recruiting and retaining study participants in anticipation of conducting a larger, multi-centered trial. However, the investigators will also obtain baseline data and follow-up measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains that the investigators hypothesize may be effected by oophorectomy: cardiovascular health, skeletal health, sexual functioning, and health-related quality-of-life.
Interventions
PROCEDUREBilateral salpingo-oophorectomy
Removal of both ovaries and fallopian tubes at the time of hysterectomy
PROCEDUREOvarian conservation
Both ovaries and fallopian tubes not removed at the time of hysterectomy
Sponsors
University of Alabama at Birmingham
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Plans to undergo hysterectomy for any non-cancerous gynecologic condition, including symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse. Hysterectomy may be done abdominally, vaginally or laparoscopically 2. Premenopausal defined as having at least one menses in the 3 months prior to surgery 3. Age \> or = 40 years 4. Speaks English or Spanish
Exclusion criteria
1. Personal or family history of breast and/or ovarian cancer (at least one first degree relative with a diagnosis of breast or ovarian cancer) or a known BRCA mutation 2. Known or suspected adnexal mass by physical exam or radiologic imaging study 3. Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis 4. Known history of coronary heart disease defined as any of the following: prior myocardial infarction, history of angioplasty, history of angina, admission to the hospital for evaluation of chest pain, or use of nitroglycerin to treat angina 5. History of stroke 6. History of osteoporosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate | start of study |
| Flow-mediated diameter of the brachial artery | Baseline and 6 months follow-up |
| Serum bone turnover markers | Baseline and 6 months follow-up |
| Sexual functioning and quality-of-life questionnaires | Baseline and 6 month follow-up |
Countries
United States
Outcome results
None listed