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

18 Years
Open (Enrolling by invite only)
Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Lymphedema, Congenital Lymphedema

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in BreastQ Questionnaire and Lymphedema Severity Score

Outcome Time Frame:

Baseline and 6 months after surgery

Safety Issue:


Principal Investigator

Marga F. Massey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Lymphology


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Lymphedema
  • Congenital Lymphedema
  • Breast Cancer
  • BRACA1/2 Genotype
  • Acquired Lymphedema
  • Congenital Lymphedema
  • Breast Neoplasms
  • Lymphedema
  • Ovarian Neoplasms



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