Actively Recruiting
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
Led by National Institute of Oncology, Hungary · Updated on 2020-04-21
110
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients under 65 years old with uni- or bilateral primary breast cancer (clinical Stage 0-III)
- Patients needing skin sparing mastectomy, nipple sparing mastectomy, or risk-reducing mastectomy regardless of axillary surgery
- Patients having immediate or delayed-immediate implant-based breast reconstruction
- Patients who volunteer for the examination and follow-ups
You will not qualify if you...
- Patients who do not volunteer for the examination or follow-ups
- Age above 65 years or poor general health with life expectancy less than 2 years without tumor
- History of malignant invasive tumors (except non-melanoma skin tumors)
- Mastectomy and reconstruction due to pregnancy-associated breast cancer
- Prior breast surgery (e.g., aesthetic surgery, mastopexy) or radiotherapy on the breast or axilla
- Malignant tumor not completely removed pathologically
- Severe non-surgical complications affecting aesthetic or functional results
- Autoimmune diseases
- Mastitis carcinomatosa
- Lymphangitis carcinomatosa
- Open wound therapy due to surgical site infection
- Long-term steroid use affecting skin quality
- Patients under foster care or who are psychically non-cooperative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institute of Oncology
Budapest, Hungary, 1122
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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