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NCT00543907 Clinical Trial

Outcomes of a Deep Inferior Epigastric Perforator Flap Program

Breast Cancer Clinical Trial

Official title:
Outcomes of a Deep Inferior Epigastric Perforator Flap Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00543907
Other study ID # 2007P000232
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2007
Est. completion date December 2008

Study information
Verified date December 2022
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 977
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Intraductal carcinoma - Lobular carcinoma - Infiltrating ductal carcinoma - Paget's disease - BRCA positive Exclusion Criteria: - Inflammatory carcinoma of the breast

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary complication rate complication rate 6 years
Secondary reconstruction rate reconstruction rate 6 years
Secondary patient satisfaction Breast Q, Michigan Breast Outcomes Survey 6 years
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