This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM with standardized horizontal skin incision.
According to our hypothesis, SRNSM with standardized technique on pendulous/ ptotic breasts is a safe procedure compared to SSM. It also promotes the cosmetic efficacy of SRNSM with the removal of the entire glandular tissue through avoidance of the reduction of projection, the need later nipple reconstruction surgery and of areola tattoo.
In our study we propose that compared to one of the well-known and widely investigated studied SSM, our current standardized SRNSM technique is able to perform similar oncologically safe entire gland tissue removal, with low complication rate, accommodating for adjuvant treatments. Furthermore, it may provide superior cosmetic results than SSM (NAC is not removed, projection is maintained, and there is no need for further nipple reconstruction or tattoo) with high patient satisfaction which is maintained long term.
Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstruction.
In case the patient does not volunteer for the examination or the follow-ups
Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease
Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
Mastectomy and reconstruction performed due pregnancy associated breast cancer
The aim of the clinical study is to measure with a long-term follow-up and with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM. The planned subgroups contain 50-50 cases. Planned number of patients (calculated patients' number plus 10%): 50x2=100 +10 cases * 110 cases should be included.
Cohort
Prospective
Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction
Procedure/SurgerySkin Reducing Nipple Sparing Mastectomy is performed from Inverted T incisuion and nipple is preserved.
Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
Procedure/SurgeryClassic Skin- Sparing Mastectomy
Oncological safety
Using correlation analysis to measure objective changes and the changes over time in oncological control achieved by different surgical techniques
Patients' satisfaction
Using correlation analysis to measure objective changes and the changes over time in patients' satisfaction achieved by different surgical techniques
Cosmetic results
Using correlation analysis to measure objective changes and the changes over time in cosmetic results achieved by different surgical techniques
Quality of life
Using correlation analysis to measure objective changes and the changes over time in quality of life achieved by different surgical techniques
Complications rate
Based on the results of this study, the aim is to determine the rate of early and late postoperative complication.
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