Outcomes of a Deep Inferior Epigastric Perforator Flap Pr... | NCT00543907

Studies
Outcomes of a Deep Inferior Epigastric Perforator Flap Program

NCT00543907

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Dec 14, 2022Actual

Enrollment

977Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007Actual

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2022

Last Update Posted Date

Dec 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bernard T. Lee, Professor of Surgery, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

977Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complication rate	complication rate	6 years

Secondary Outcomes

Measure	Description	Time Frame
reconstruction rate	reconstruction rate	6 years
patient satisfaction	Breast Q, Michigan Breast Outcomes Survey	6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inflammatory carcinoma of the breast

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard T Lee, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided