- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543764
Intraoperative Pathway in DIEP Flap Breast Reconstruction
February 26, 2019 updated by: Bernard T. Lee, Beth Israel Deaconess Medical Center
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.
Study Overview
Detailed Description
A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
Study Type
Observational
Enrollment (Actual)
150
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
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing breast reconstruction
Description
Inclusion Criteria:
- All cases prior to pathway
Exclusion Criteria:
- None
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre pathway
|
|
Post pathway
|
Comparison of pre and post pathway
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative Time
Time Frame: 3 years
|
Length of Time in surgery
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2005
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 12, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 15, 2007
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2007-P-000266/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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