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Intraoperative Pathway in DIEP Flap Breast Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543764
First Posted: October 15, 2007
Last Update Posted: July 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bernard T. Lee, Beth Israel Deaconess Medical Center
  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 Other: Use of an intraoperative pathway

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intraoperative Pathway in DIEP Flap Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Bernard T. Lee, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 3 years ]
    Length of Time in surgery


Enrollment: 150
Study Start Date: January 2005
Study Completion Date: February 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pre pathway
Pre pathway
Post pathway
Post pathway
Other: Use of an intraoperative pathway
Utilization of an intraoperative pathway

Detailed Description:
A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing breast reconstruction
Criteria

Inclusion Criteria:

  • All cases prior to pathway

Exclusion Criteria:

  Contacts and Locations
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): NCT00543764


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Bernard T Lee, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Bernard T. Lee, Assistant Professor in Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00543764     History of Changes
Other Study ID Numbers: 2007-P-000266/1
First Submitted: October 12, 2007
First Posted: October 15, 2007
Results First Submitted: October 19, 2010
Results First Posted: July 6, 2012
Last Update Posted: July 6, 2012
Last Verified: May 2012

Keywords provided by Bernard T. Lee, Beth Israel Deaconess Medical Center:
Intraoperative Pathway
Breast Reconstruction
DIEP flap