RecruitingNCT04345081

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

Examining the Cosmetic Results and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy of Ptotic Breast Followed by Delayed-immediate Submuscular Implant Based- Breast Reconstruction Surgery, and Comparing it to Submuscular Delayed- Immediate Implant- Based Breast Reconstruction Procedures After Skin- Sparing Mastectomy. Response-adaptive, Prospective Randomized Clinical Trial


Sponsor

National Institute of Oncology, Hungary

Enrollment

110 participants

Start Date

Apr 18, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing cosmetic outcomes, quality of life, and patient satisfaction between different types of mastectomy and breast reconstruction techniques — including nipple-sparing and skin-sparing approaches — to understand which methods lead to the best results for patients. **You may be eligible if:** - You are under 65 years old - You have primary breast cancer (stage 0–III) in one or both breasts, or you are having a preventive (risk-reducing) mastectomy - You are having a skin-sparing or nipple-sparing mastectomy with immediate or delayed implant-based reconstruction **You may NOT be eligible if:** - You do not wish to participate or attend follow-up appointments - You are 65 or older, or in poor enough general health that your life expectancy is less than 2 years - You have had another type of invasive cancer in the past (except non-melanoma skin cancer) - Your mastectomy is due to pregnancy-related breast cancer - You have had previous breast surgery (such as cosmetic surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESkin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction

Skin Reducing Nipple Sparing Mastectomy is performed from Inverted T incisuion and nipple is preserved.

PROCEDURESkin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery

Classic Skin- Sparing Mastectomy


Locations(1)

National Institute of Oncology

Budapest, Hungary

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NCT04345081


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