Prospective Non-randomized Evaluation of Oncoplastic Surgery

Medical University of Vienna150 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Breast Image Scale Index for Self Esteem Evaluation Breast Symmetry Index Quality of Life Morbidity Oncological Outcome

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.

Time frame: 2 years

Secondary Outcomes

quality of life

BREAST Q, non-validated questionnaires

Time frame: 2 years

Morbidity

Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery

Time frame: 6 months

breast symmetry index

Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery

Time frame: 2 years

oncologic parameters

local, distent and overal survival 2 as well as 5 years after surgery will be assessed

Time frame: 2-5 years

Prospective Non-randomized Evaluation of Oncoplastic Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes