Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
NCT ID: NCT01273909
Last Updated: 2014-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2010-07-31
2016-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perforator Flap Breast Reconstruction
Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Vascularized Lymph Node Transfer
Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Interventions
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Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unable to read
18 Years
ALL
No
Sponsors
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The DrMarga Practice Group
UNKNOWN
The Center for Restorative Breast Surgery, LLC
OTHER
The National Institute of Lymphology
INDUSTRY
Responsible Party
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Marga F. Massey, M.D.
Principle Investigator
Principal Investigators
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Marga F. Massey, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Lymphology
Locations
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National Institute of Lymphology
Chicago, Illinois, United States
The Center for Restorative Breast Surgery
New Orleans, Louisiana, United States
The DrMarga Practice Group
Charleston, South Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1116697
Identifier Type: OTHER
Identifier Source: secondary_id
MFM001
Identifier Type: -
Identifier Source: org_study_id
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