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

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ClinicalTrials.gov Identifier: NCT01273909

Recruitment Status : Unknown

Verified June 2014 by Marga F. Massey, M.D., The National Institute of Lymphology.
Recruitment status was: Enrolling by invitation

First Posted : January 11, 2011

Last Update Posted : June 6, 2014

Sponsor:

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

Study Description

Brief Summary:

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

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.

Study Design


Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Study Start Date :	July 2010
Estimated Primary Completion Date :	January 2016
Estimated Study Completion Date :	January 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Milroy disease Breast cancer Lymphedema-distichiasis syndrome Ovarian cancer

MedlinePlus related topics: Breast Reconstruction Lymphedema Plastic and Cosmetic Surgery

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Congenital Lymphedema Milroy Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Group/Cohort

Intervention/treatment

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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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
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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:

National Institute of Lymphology research web page This link exits the ClinicalTrials.gov site

Publications:

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):737-51. doi: 10.1097/PRS.0b013e3181b17a56.

Gärtner 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. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

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.

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.

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. Review.


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 Posted:	January 11, 2011 Key Record Dates
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

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