Prospective Non-randomized Evaluation of Oncoplastic Surgery

Overview

Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.

Full Title of Study: “Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2015

Interventions

  • Procedure: Breast Surgery
    • breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
  • Procedure: Breast Surgery
    • Breast conserving therapy without defect correction

Arms, Groups and Cohorts

  • iTOP
    • Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction
  • BCT
    • patients undergoing conservative breast surgery

Clinical Trial Outcome Measures

Primary Measures

  • breast image scale
    • Time Frame: 2 years
    • self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.

Secondary Measures

  • quality of life
    • Time Frame: 2 years
    • BREAST Q, non-validated questionnaires
  • Morbidity
    • Time Frame: 6 months
    • Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery
  • breast symmetry index
    • Time Frame: 2 years
    • Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery
  • oncologic parameters
    • Time Frame: 2-5 years
    • local, distent and overal survival 2 as well as 5 years after surgery will be assessed

Participating in This Clinical Trial

Inclusion Criteria

  • Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed) – BIRADS IV, V or VI are eligible – > 18 years of age – Psychological and physical capable of understanding and performing the trial – Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant Exclusion Criteria:

  • Inflammatory breast cancer – Progression after neoadjuvant therapy – Pregnant women – Patients unable to perform surgery under general anaesthesia – Bilateral breast lesions

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Florian Fitzal, Professor of Surgery – Medical University of Vienna

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