Clinical Trial: Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
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.
Detailed Summary:
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.
Sponsor: The National Institute of Lymphology
Current Primary Outcome: Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: Baseline and 6 months after surgery ]
Original Primary Outcome: Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: 6 months after surgery ]
Current Secondary Outcome: Persistent Postsurgical Pain assessment questionnaire [ Time Frame: 6 months after surgery ]
Original Secondary Outcome: Same as current
Information By: The National Institute of Lymphology
Dates:
Date Received: January 7, 2011
Date Started: July 2010
Date Completion: January 2016
Last Updated: June 4, 2014
Last Verified: June 2014
