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Actively Recruiting

Age: 18Years - 65Years
FEMALE
ID04345081

Comparing Skin Reducing Nipple Sparing Mastectomy with Delayed-Immediate Implant Breast Reconstruction to Classic Skin-Sparing Mastectomy and Implant Reconstruction in Breast Cancer Patients under 65

Led by National Institute of Oncology, Hungary · Updated on 2020-04-21

110

Participants Needed

1

Research Sites

260 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the cosmetic outcomes, quality of life, and patient satisfaction between two types of breast reconstruction surgeries following mastectomy in women with breast cancer. It focuses on delayed-immediate breast reconstruction using Skin Reducing Nipple Sparing Mastectomy SRNSM and classic Skin Sparing Mastectomy SSM. The study hypothesizes that SRNSM, especially in women with pendulous or ptotic breasts, may provide safe and superior cosmetic results with maintained nipple projection and less need for further nipple reconstruction or tattooing. Participants undergo either SRNSM or SSM, both followed by delayed-immediate implant-based breast reconstruction using standardized surgical techniques. SRNSM involves an inverted T incision with preservation of the nipple, while SSM is a classic skin-sparing procedure. The surgeries include removal of the entire glandular tissue and may involve axillary lymph node procedures if needed. The study observes these procedures under routine clinical protocols without altering oncological treatments. Participants are assessed before surgery and followed up for five years, with evaluations every 6 months after the initial postoperative checks. Assessments include photo documentation, body measurements, and completion of the BREAST-Q questionnaire to measure quality of life and satisfaction. Cosmetic results are also evaluated by independent breast surgeons using photographs. The study monitors oncological safety, patient satisfaction, cosmetic outcomes, quality of life, and complication rates over this long-term follow-up period.

CONDITIONS

Brief 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

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