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

• Conditions: Breast Cancer; Hereditary Breast/Ovarian Cancer (brca1, brca2); Acquired Lymphedema; Congenital Lymphedema
• Interventions: Procedure: Perforator Flap Breast Reconstruction; Procedure: Vascularized Lymph Node Transfer

• Registration Number: NCT01273909
• Lead Sponsor: The National Institute of Lymphology

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 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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-06
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perforator Flap Breast Reconstruction	Perforator Flap Breast Reconstruction	Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
Perforator Flap Breast Reconstruction	Vascularized Lymph Node Transfer	Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
Vascularized Lymph Node Transfer	Perforator Flap Breast Reconstruction	Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
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

Primary Outcome Measures

Name	Time	Method
Change in BreastQ Questionnaire and Lymphedema Severity Score	Baseline and 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Persistent Postsurgical Pain assessment questionnaire	6 months after surgery

Trial Locations

Locations (3)

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