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

NCT01273909 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2014-06-06

No results posted yet for this study

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

Interventions

PROCEDURE

Perforator Flap Breast Reconstruction

perforator flap breast reconstruction with or without vascularized lymph node transfer

PROCEDURE

Vascularized Lymph Node Transfer

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

Sponsors & Collaborators

  • The DrMarga Practice Group

    collaborator UNKNOWN

  • The Center for Restorative Breast Surgery, LLC

    collaborator OTHER

  • The National Institute of Lymphology

    lead INDUSTRY

Principal Investigators

  • Marga F. Massey, M.D. · National Institute of Lymphology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273909 on ClinicalTrials.gov