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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Surgery | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| breast image scale | self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | BREAST Q, non-validated questionnaires | 2 years |
| Morbidity | Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| Breast Surgery | Procedure | Breast conserving therapy without defect correction |
|
| 6 months |
| breast symmetry index | Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery | 2 years |
| oncologic parameters | local, distent and overal survival 2 as well as 5 years after surgery will be assessed | 2-5 years |