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| ID | Type | Description | Link |
|---|---|---|---|
| 1116697 | Other Identifier | Western Institutional Review Board |
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| Name | Class |
|---|---|
| The DrMarga Practice Group | UNKNOWN |
| The Center for Restorative Breast Surgery, LLC | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perforator Flap Breast Reconstruction | Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer |
| |
| Vascularized Lymph Node Transfer | Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perforator Flap Breast Reconstruction | Procedure | perforator flap breast reconstruction with or without vascularized lymph node transfer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BreastQ Questionnaire and Lymphedema Severity Score | Baseline and 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Postsurgical Pain assessment questionnaire | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marga F. Massey, M.D. | National Institute of Lymphology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Lymphology | Chicago | Illinois | 60611 | United States | ||
| The Center for Restorative Breast Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19730293 | Background | Massey MF, Spiegel AJ, Levine JL, Craigie JE, Kline RM, Khoobehi K, Erhard H, Greenspun DT, Allen RJ Jr, Allen RJ Sr; Group for the Advancement of Breast Reconstruction. Perforator flaps: recent experience, current trends, and future directions based on 3974 microsurgical breast reconstructions. Plast Reconstr Surg. 2009 Sep;124(3):737-751. doi: 10.1097/PRS.0b013e3181b17a56. | |
| 19903919 |
| Label | URL |
|---|---|
| National Institute of Lymphology research web page | View source |
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| Vascularized Lymph Node Transfer | Procedure | perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction |
|
|
| New Orleans |
| Louisiana |
| 70130 |
| United States |
| The DrMarga Practice Group | Charleston | South Carolina | 29403 | United States |
| Background |
| Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. |
| 19292814 | Background | Dayangac M, Makay O, Yeniay L, Aynaci M, Kapkac M, Yilmaz R. Precipitating factors for lymphedema following surgical treatment of breast cancer: implications for patients undergoing axillary lymph node dissection. Breast J. 2009 Mar-Apr;15(2):210-1. doi: 10.1111/j.1524-4741.2009.00703.x. No abstract available. |
| 16495693 | Background | Becker C, Assouad J, Riquet M, Hidden G. Postmastectomy lymphedema: long-term results following microsurgical lymph node transplantation. Ann Surg. 2006 Mar;243(3):313-5. doi: 10.1097/01.sla.0000201258.10304.16. |
| 18519968 | Background | Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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