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Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Recruitment status was: Enrolling by invitation
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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 |
- Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: Baseline and 6 months after surgery ]
- 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:
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:
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01273909
| 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 | |
| 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 ) |
| Study First Received: | January 7, 2011 |
| Last Updated: | June 4, 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 |
ClinicalTrials.gov processed this record on June 22, 2017