Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Image Scale Index for Self Esteem Evaluation
- Sponsor
- Medical University of Vienna
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- breast image scale
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Florian Fitzal
Professor of Surgery
Medical University of Vienna
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Morbidity(6 months)
- breast symmetry index(2 years)
- oncologic parameters(2-5 years)
- quality of life(2 years)