Outcomes of a DIEP Flap Program
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Beth Israel Deaconess Medical Center.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Bernard T. Lee, Beth Israel Deaconess Medical Center
First received: October 12, 2007
Last updated: February 1, 2012
Last verified: February 2012
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.
||Observational Model: Cohort
Time Perspective: Retrospective
||Outcomes of a DIEP Flap Program
Primary Outcome Measures:
- reconstruction rate [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- complication rate, patient satisfaction, costs, referral pattern [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
Patients who have undergone mastectomy for breast cancer prior to implementation of the DIEP flap microsurgical breast reconstruction program
Patients who have undergone mastectomy for breast cancer after implementation of the DIEP flap microsurgical breast reconstruction program
|Ages Eligible for Study:
||20 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All women who have undergone mastectomy for breast cancer between 2001 and 2007 at the BIDMC.
- Intraductal carcinoma
- Lobular carcinoma
- Infiltrating ductal carcinoma
- Paget's disease
- BRCA positive
- Inflammatory carcinoma of the breast
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00543907
|Beth Israel Deaconess Medical Center
|Boston, Massachusetts, United States, 02215 |
|Contact: Bernard T Lee, MD 617-632-7835 email@example.com |
Beth Israel Deaconess Medical Center
||Bernard T Lee, MD
||Beth Israel Deaconess Medical Center
No publications provided
||Bernard T. Lee, Assistant Professor of Surgery, Beth Israel Deaconess Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2007
||February 1, 2012
||United States: Institutional Review Board
Keywords provided by Beth Israel Deaconess Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
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