Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors.
J H Rowland, K A Desmond, B E Meyerowitz...
https://pubmed.ncbi.nlm.nih.gov/10974078/Actively Recruiting
Led by National Institute of Oncology, Hungary · Updated on 2020-04-21
110
Participants Needed
1
Research Sites
260 weeks
Total Duration
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
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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National Institute of Oncology, Hungary
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus initial hospitalization period
Participants undergo either Skin Reducing Nipple Sparing Mastectomy or classic Skin Sparing Mastectomy followed by immediate or delayed-immediate implant-based breast reconstruction.
1 visit (surgery and hospitalization)
Duration - Up to 5 years after surgery
Participants attend follow-up visits for body measurements, photo documentation, and quality of life assessments using questionnaires up to five years after surgery.
Visits at 4-6 weeks, 3 months, 6 months, then every 6 months up to 5 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor