Bilateral Oophorectomy Versus Ovarian Conservation

Hysterectomy Clinical Trial

Official title:

Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007305
• Other study ID #: BSO 01
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: August 4, 2011
• Start date: May 2009

Study information

• Verified date: November 2009
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hysterectomy
• Oophorectomy

Intervention

Procedure:
• Bilateral salpingo-oophorectomy
Removal of both ovaries and fallopian tubes at the time of hysterectomy
• Ovarian conservation
Both ovaries and fallopian tubes not removed at the time of hysterectomy

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of California, Sans Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate		start of study	No
Primary	Flow-mediated diameter of the brachial artery		Baseline and 6 months follow-up	No
Primary	Serum bone turnover markers		Baseline and 6 months follow-up	No
Primary	Sexual functioning and quality-of-life questionnaires		Baseline and 6 month follow-up	No