Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Lymphedema

Lymphatic Diseases

Quality of Life

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.

This Group receive Skin Reducing Nipple Sparing Mastectomy

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.

This Group receive Skin Sparing Mastectomy

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

Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction

Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery

Zoltan Matrai, M.D. Dr. med. habil, PhD

Zoltan Matrai, M.D. Dr. Habil Ph.D. FEBS

Mihaly Ujhelyi, M.D. Ph.D. FEBS

Akos Savolt, M.D. Ph.D. FEBS

Peter Kelemen, M.D. FEBS

Orsolya Huszár, M.D.

Orsolya Ping, M.D.

Szilard Domjan, M.D.

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.

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

Using correlation analysis to measure objective changes and the changes over time in oncological control achieved by different surgical techniques

Using correlation analysis to measure objective changes and the changes over time in patients' satisfaction achieved by different surgical techniques

Using correlation analysis to measure objective changes and the changes over time in cosmetic results achieved by different surgical techniques

Using correlation analysis to measure objective changes and the changes over time in quality of life achieved by different surgical techniques

Based on the results of this study, the aim is to determine the rate of early and late postoperative complication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT04345081	Breast Cancer Mastectomy; Lym... Quality of Life Patient Satisfa...	Skin Reducing N... Skin- Sparing M...	18 Years - 65 Years	National Institute of Oncology, Hungary
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	NCT04345081	Breast Cancer Mastectomy; Lym... Quality of Life Patient Satisfa...	Skin Reducing N... Skin- Sparing M...	18 Years - 65 Years	National Institute of Oncology, Hungary

Spots Global Cancer Trial Database for skin reducing nipple sparing mastectomy and implant based breast reconstruction