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

NCT01273909 | Unknown

• 2 other identifiers: MFM0011116697
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Hereditary Breast/Ovarian Cancer (brca1, brca2); Acquired Lymphedema; Congenital Lymphedema

Keywords

Breast Cancer; BRACA1/2 Genotype; Acquired Lymphedema; Congenital Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in BreastQ Questionnaire and Lymphedema Severity Score

  Baseline and 6 months after surgery

Secondary Outcomes (1)

• Persistent Postsurgical Pain assessment questionnaire

  6 months after surgery

Study Arms (2)

Perforator Flap Breast Reconstruction

Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer

Procedure: Perforator Flap Breast Reconstruction; Procedure: 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

Procedure: Perforator Flap Breast Reconstruction; Procedure: Vascularized Lymph Node Transfer

Interventions

Perforator Flap Breast Reconstruction PROCEDURE

perforator flap breast reconstruction with or without vascularized lymph node transfer

Also known as: DIEP Flap, SGAP Flap, IGAP Flap, SIEA Flap, TUG Flap, TDAP Flap, ICP Flap

Perforator Flap Breast Reconstruction; Vascularized Lymph Node Transfer

Vascularized Lymph Node Transfer PROCEDURE

perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction

Also known as: VLNTx

Perforator Flap Breast Reconstruction; Vascularized Lymph Node Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema

You may not qualify if:

• Pregnant
• unable to read

Sponsors & Collaborators

• The National Institute of Lymphology: lead
• The DrMarga Practice Group: collaborator
• The Center for Restorative Breast Surgery, LLC: collaborator

Study Sites (3)

National Institute of Lymphology

Chicago, Illinois, 60611, United States

Location

The Center for Restorative Breast Surgery

New Orleans, Louisiana, 70130, United States

Location

The DrMarga Practice Group

Charleston, South Carolina, 29403, United States

Location

Related Publications (5)

• 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.

  PMID: 19730293 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.

  PMID: 19903919 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.

  PMID: 19292814 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.

  PMID: 16495693 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.

  PMID: 18519968 BACKGROUND

Related Links

• National Institute of Lymphology research web page

MeSH Terms

Conditions

Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Gonadal Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Marga F. Massey, M.D.

  National Institute of Lymphology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

US (3)