Outcomes of a DIEP Flap Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Bernard T. Lee, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00543907
First received: October 12, 2007
Last updated: February 17, 2015
Last verified: February 2015
  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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes of a DIEP Flap Program

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

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: 2400
Study Start Date: September 2007
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre
Patients who have undergone mastectomy for breast cancer prior to implementation of the DIEP flap microsurgical breast reconstruction program
Post
Patients who have undergone mastectomy for breast cancer after implementation of the DIEP flap microsurgical breast reconstruction program

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543907

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

Locations
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
Principal Investigator: Bernard T Lee, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Bernard T. Lee, Assistant Professor of Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00543907     History of Changes
Other Study ID Numbers: 2007-P-000232/1
Study First Received: October 12, 2007
Last Updated: February 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
breast reconstruction
DIEP flap

ClinicalTrials.gov processed this record on July 01, 2015