Intraoperative Pathway in DIEP Flap Breast Reconstruction

This study is currently recruiting participants.

Verified by Beth Israel Deaconess Medical Center, May 2008

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00543764

Purpose

Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Condition	Intervention
Breast Cancer	Procedure: Pathway

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Breast Reconstruction Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intraoperative Pathway in DIEP Flap Breast Reconstruction

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

Primary Outcome Measures:

Operative Time [ Time Frame: 3 years ]

Estimated Enrollment:	200
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1: No Intervention Pre pathway
2: Experimental Post pathway	Procedure: Pathway Utilization of an intraoperative pathway

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All cases prior to pathway

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543764

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
Principal Investigator: Bernard T Lee, MD
Sub-Investigator: Janet H Yueh, BA
Sub-Investigator: Donald W Moorman, MD
Sub-Investigator: Adam M Tobias, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Bernard T Lee, MD

Beth Israel Deaconess Medical Center

More Information

Study ID Numbers:	2007-P-000266/1
Study First Received:	October 12, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00543764
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Intraoperative Pathway
Breast Reconstruction
DIEP flap

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009