Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

June 4, 2014 updated by: Marga F. Massey, M.D., The National Institute of Lymphology

The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.

The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.

The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.

Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.

The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • National Institute of Lymphology
    • Louisiana
      • New Orleans, Louisiana, United States, 70130
        • The Center for Restorative Breast Surgery
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • The DrMarga Practice Group

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects who are patients of the "Dr Marga" Practice or the Center for Restorative Breast Surgery that consent to participate in this research study will be selected. There is no age, ethnicity or gender requirement.

Description

Inclusion Criteria:

  • Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema

Exclusion Criteria:

  • Pregnant
  • unable to read

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perforator Flap Breast Reconstruction
Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
Procedure: Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
Other Names:
  • DIEP Flap
  • SGAP Flap
  • IGAP Flap
  • SIEA Flap
  • TUG Flap
  • TDAP Flap
  • ICP Flap
Procedure: Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Other Names:
  • VLNTx
Vascularized Lymph Node Transfer
Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Procedure: Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
Other Names:
  • DIEP Flap
  • SGAP Flap
  • IGAP Flap
  • SIEA Flap
  • TUG Flap
  • TDAP Flap
  • ICP Flap
Procedure: Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Other Names:
  • VLNTx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in BreastQ Questionnaire and Lymphedema Severity Score
Time Frame: Baseline and 6 months after surgery
Baseline and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Persistent Postsurgical Pain assessment questionnaire
Time Frame: 6 months after surgery
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Institute of Lymphology

Collaborators

The DrMarga Practice Group
The Center for Restorative Breast Surgery, LLC

Investigators

  • Principal Investigator: Marga F. Massey, M.D., National Institute of Lymphology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

July 1, 2010

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFM001
  • 1116697 (Other Identifier: Western Institutional Review Board)

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.

Clinical Trials on Breast Cancer

Clinical Trials on Perforator Flap Breast Reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe