RecruitingNot Applicable

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

Hungary110 participantsStarted 2020-04-18

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Prior breast surgery (e.g. aesthetic surgery, mastopexy) and/or radiotherapy on the breast or in the axilla * Malignant tumor is not removed completely with pathological examination * Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results * Autoimmune diseases * Mastitis carcinomatosa * Lymphangitis carcinomatosa * Open wound therapy due SSI * Long-term steroid usage, which changed the skin's quality and structure * Patient under foster care, or psychically non-cooperative patient

What they're measuring

Oncological safety

Timeframe: five years of follow-up

Patients' satisfaction

Timeframe: five years of follow-up

Cosmetic results

Timeframe: five years of follow-up

Quality of life

Timeframe: five years of follow-up

Trial details

NCT IDNCT04345081

SponsorNational Institute of Oncology, Hungary

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-05

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.