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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Marga F. Massey, M.D., The National Institute of Lymphology.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273909
First Posted: January 11, 2011
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The DrMarga Practice Group
The Center for Restorative Breast Surgery, LLC
Information provided by (Responsible Party):
Marga F. Massey, M.D., The National Institute of Lymphology
  Purpose

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.


Condition Intervention
Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Acquired Lymphedema Congenital Lymphedema Procedure: Perforator Flap Breast Reconstruction Procedure: Vascularized Lymph Node Transfer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

Resource links provided by NLM:


Further study details as provided by Marga F. Massey, M.D., The National Institute of Lymphology:

Primary Outcome Measures:
  • Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: Baseline and 6 months after surgery ]

Secondary Outcome Measures:
  • Persistent Postsurgical Pain assessment questionnaire [ Time Frame: 6 months after surgery ]

Estimated Enrollment: 1000
Study Start Date: July 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: VLNTx

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273909


Locations
United States, Illinois
National Institute of Lymphology
Chicago, Illinois, United States, 60611
United States, Louisiana
The Center for Restorative Breast Surgery
New Orleans, Louisiana, United States, 70130
United States, South Carolina
The DrMarga Practice Group
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
The National Institute of Lymphology
The DrMarga Practice Group
The Center for Restorative Breast Surgery, LLC
Investigators
Principal Investigator: Marga F. Massey, M.D. National Institute of Lymphology
  More Information

Additional Information:
Publications:
Responsible Party: Marga F. Massey, M.D., Principle Investigator, The National Institute of Lymphology
ClinicalTrials.gov Identifier: NCT01273909     History of Changes
Other Study ID Numbers: MFM001
1116697 ( Other Identifier: Western Institutional Review Board )
First Submitted: January 7, 2011
First Posted: January 11, 2011
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Marga F. Massey, M.D., The National Institute of Lymphology:
Breast Cancer
BRACA1/2 Genotype
Acquired Lymphedema
Congenital Lymphedema

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases