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Outcomes of a Deep Inferior Epigastric Perforator Flap Program

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ClinicalTrials.gov Identifier: NCT00543907
Recruitment Status : Recruiting
First Posted : October 15, 2007
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Bernard T. Lee, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

Condition or disease
Breast Cancer

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes of a Deep Inferior Epigastric Perforator Flap Program
Study Start Date : September 2007
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Pre programmatic development
Patients who have undergone mastectomy for breast cancer prior to implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program
Post programmatic development
Patients who have undergone mastectomy for breast cancer after implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program


Outcome Measures
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Primary Outcome Measures :
  1. complication rate [ Time Frame: 6 years ]
    complication rate


Secondary Outcome Measures :
  1. reconstruction rate [ Time Frame: 6 years ]
    reconstruction rate

  2. patient satisfaction [ Time Frame: 6 years ]
    Breast Q, Michigan Breast Outcomes Survey


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women who have undergone mastectomy for breast cancer between 2001 and 2007 at the BIDMC.
Criteria

Inclusion Criteria:

  • Intraductal carcinoma
  • Lobular carcinoma
  • Infiltrating ductal carcinoma
  • Paget's disease
  • BRCA positive

Exclusion Criteria:

  • Inflammatory carcinoma of the breast
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): NCT00543907


Contacts
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Contact: Bernard T Lee, MD 617.632.7835 blee3@bidmc.harvard.edu

Locations
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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   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Bernard T Lee, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Bernard T. Lee, Professor of Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00543907    
Other Study ID Numbers: 2007P000232
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bernard T. Lee, Beth Israel Deaconess Medical Center:
breast reconstruction
DIEP flap