At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established...
Date First Received: April 3, 2008
Last Updated: April 8, 2008
Verified by: Parker, William H., M.D., April 2008
Clinical Trial Phase: N/A | Start Date: January 1980
Overall Status: Completed
Estimated Enrollment: 32175
Brief Summary
Official Title: “Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established.
Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective
Study Primary Completion Date: June 2004
Detailed Clinical Trial Description
We are conducting a prospective, observational study of 32,175 women participants of the Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are evaluating mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- all women having a hysterectomy with oophorectomy
- : 2
- all women having a hysterectomy without removal of ovaries
Outcome Measures for this Clinical Trial
Primary Measures
- mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
- Time Frame: 28 years
Safety Issue?: No
- Time Frame: 28 years
Secondary Measures
- The effect of postmenopausal hormone use on mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
- Time Frame: 28 years
Safety Issue?: No
- Time Frame: 28 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.
Exclusion Criteria:
- Evidence of cancer, coronary heart disease (MI or Angina Pectoris), stroke, or hip fracture before entering the study were excluded. Cancer as an indication for hysterectomy also excluded.
- Women reporting unilateral oophorectomy, unknown oophorectomy status, unknown age of hysterectomy, or those who had oophorectomy before hysterectomy were excluded.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Parker, William H., M.D.
Overall Clinical Trial Officials and Contacts
William H Parker, MD Principal Investigator John Wayne Cancer Institute
Related Publications
References
Parker WH, Broder MS, Liu Z, Shoupe D, Farquhar C, Berek JS. Ovarian conservation at the time of hysterectomy for benign disease. Obstet Gynecol. 2005 Aug;106(2):219-26.
Additional Information
Information obtained from ClinicalTrials.gov on September 01, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655447
Study ID Number: PARW-OVCONS-0307
ClinicalTrials.gov Identifier: NCT00655447
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
