Clinical Trial on Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

977

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All women who have undergone mastectomy for breast cancer between 1999 and 2008 at the BIDMC.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Inflammatory carcinoma of the breast

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate Time Frame: 6 years	complication rate	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reconstruction rate Time Frame: 6 years	reconstruction rate	6 years
patient satisfaction Time Frame: 6 years	Breast Q, Michigan Breast Outcomes Survey	6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria