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| Sponsored by: |
Beth Israel Deaconess Medical Center |
|---|---|
| Information provided by: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00543907 |
Purpose
The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.
| Condition |
|---|
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Breast Cancer |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | Outcomes of a DIEP Flap Program |
| Estimated Enrollment: | 2400 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | August 2008 |
| Groups/Cohorts |
|---|
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Pre
Patients who have undergone mastectomy for breast cancer prior to implementation of the DIEP flap microsurgical breast reconstruction program
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Post
Patients who have undergone mastectomy for breast cancer after implementation of the DIEP flap microsurgical breast reconstruction program
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Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All women who have undergone mastectomy for breast cancer between 2001 and 2007 at the BIDMC.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bernard T Lee, MD | 617.632.7835 | blee3@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Bernard T Lee, MD 617-632-7835 blee3@bidmc.harvard.edu | |
| Sub-Investigator: Janet H Yueh, BA | |
| Principal Investigator: | Bernard T Lee, MD | Beth Israel Deaconess Medical Center |
More Information
| Study ID Numbers: | 2007-P-000232/1 |
| Study First Received: | October 12, 2007 |
| Last Updated: | May 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00543907 |
| Health Authority: | United States: Institutional Review Board |
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breast reconstruction DIEP flap |
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Skin Diseases Breast Neoplasms Breast Diseases |
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Neoplasms Neoplasms by Site |
