Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Morbidity, Oncological Outcome, Quality of Life
Conditions
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.
Interventions
PROCEDUREBreast 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
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast image scale | 2 years | self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 2 years | BREAST Q, non-validated questionnaires |
| Morbidity | 6 months | Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery |
| breast symmetry index | 2 years | Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery |
| oncologic parameters | 2-5 years | local, distent and overal survival 2 as well as 5 years after surgery will be assessed |
Countries
Austria
Outcome results
None listed