NCT00543907

Brief Summary

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
977

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
1 month 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

October 12, 2007

Last Update Submit

December 13, 2022

Conditions

Breast Cancer

Keywords

breast reconstructionDIEP flap

Outcome Measures

Primary Outcomes (1)

  • complication rate

    complication rate

    6 years

Secondary Outcomes (2)

  • reconstruction rate

    6 years

  • patient satisfaction

    6 years

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Inflammatory carcinoma of the breast

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

Study Officials

  • Bernard T Lee, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 15, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)