Examining the Long-Term Risks of Oophorectomy

NCT ID: NCT00655447

Last Updated: 2008-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32175 participants

Study Classification

OBSERVATIONAL

Study Start Date

1980-01-31

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease Stroke Breast Cancer Ovarian Cancer Cancer Hip Fracture Death

Keywords

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oophorectomy ovarian conservation stroke breast cancer ovarian cancer other cancer hip fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

all women having a hysterectomy with oophorectomy

No interventions assigned to this group

2

all women having a hysterectomy without removal of ovaries

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role collaborator

Parker, William H., M.D.

OTHER

Sponsor Role lead

Responsible Party

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John Wayne Cancer Institute

Principal Investigators

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William H Parker, MD

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

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Parker, Rosenman, Rodi Gynecology Group

Santa Monica, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/01.AOG.0000167394.38215.56.

Reference Type BACKGROUND
PMID: 16055568 (View on PubMed)

Other Identifiers

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PARW-OVCONS-0307

Identifier Type: -

Identifier Source: org_study_id