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Examining the Long-Term Risks of Oophorectomy

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ClinicalTrials.gov Identifier: NCT00655447
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 9, 2008
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
Parker, William H., M.D.

Study Description
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Brief Summary:
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.

Condition or disease
Coronary Heart Disease Stroke Breast Cancer Ovarian Cancer Cancer Hip Fracture Death

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 32175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.
Study Start Date : January 1980
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
all women having a hysterectomy with oophorectomy
2
all women having a hysterectomy without removal of ovaries


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nurses' Health Study I, which included 122,701 married registered nurses living in 11 U.S. states and who were ages 30 to 55 in 1976
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655447


Locations
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United States, California
Parker, Rosenman, Rodi Gynecology Group
Santa Monica, California, United States, 90401
Sponsors and Collaborators
Parker, William H., M.D.
Ethicon, Inc.
Investigators
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Principal Investigator: William H Parker, MD Saint John's Cancer Institute
More Information
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Publications:

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Responsible Party: William Parker, John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT00655447    
Other Study ID Numbers: PARW-OVCONS-0307
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: April 9, 2008
Last Verified: April 2008
Keywords provided by Parker, William H., M.D.:
oophorectomy
ovarian conservation
stroke
breast cancer
 ovarian cancer
other cancer
hip fracture
Additional relevant MeSH terms:
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Ovarian Neoplasms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hip Fractures
Neoplasms by Site
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Fractures, Bone
Wounds and Injuries
 Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Femoral Fractures
Hip Injuries
Leg Injuries
Arteriosclerosis
Arterial Occlusive Diseases