Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
N/A
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Female
Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life, Morbidity, Oncological Outcome
Female
Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life, Morbidity, Oncological Outcome
Trial Information
Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
breast image scale
Outcome Description:
self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
Austria: Ethikkommission
Study ID:
iTOP
NCT ID:
NCT01396993
Start Date:
July 2011
Completion Date:
July 2016
Related Keywords:
- Breast Image Scale Index for Self Esteem Evaluation
- Breast Symmetry Index
- Quality of Life
- Morbidity
- Oncological Outcome
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