NCT00543764

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 6, 2012

Completed
Last Updated

March 7, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

October 12, 2007

Results QC Date

October 19, 2010

Last Update Submit

February 26, 2019

Conditions

Breast Cancer

Keywords

Intraoperative PathwayBreast ReconstructionDIEP flap

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    Length of Time in surgery

    3 years

Study Arms (2)

Pre pathway

Pre pathway

Post pathway

Post pathway

Other: pathway

Interventions

pathwayOTHER

Comparison of pre and post pathway

Also known as: intraoperative pathway
Post pathway

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing breast reconstruction

You may qualify if:

  • All cases prior to pathway

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

More patient enrollment is necessary to ascertain long term outcomes

Results Point of Contact

Title
Bernard Lee
Organization
BIDMC
blee3@bidmc.harvard.edu
617-632-7835

Study Officials

  • Bernard T Lee, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Surgery

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 15, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2008

Study Completion

February 1, 2011

Last Updated

March 7, 2019

Results First Posted

July 6, 2012

Record last verified: 2019-02

Locations

US(1)