Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer.
Umberto Veronesi, Natale Cascinelli, Luigi Mariani...
https://pubmed.ncbi.nlm.nih.gov/12393819/Actively Recruiting
Led by National Institute of Oncology, Hungary · Updated on 2020-04-21
242
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are evaluating the clinical, oncological, and aesthetic outcomes and patients quality of life and satisfaction following two types of oncoplastic breast conserving surgeries in women with early unilateral breast cancer. This responsive-adaptive prospective randomized study compares the widely studied round-block technique with the newer retroglandular technique, hypothesizing both provide safe tumor removal with low complication rates, good cosmetic results, and sustained patient satisfaction after whole breast irradiation. Participants receive either round-block or retroglandular oncoplastic breast conserving surgery, both standardized surgical procedures adapted to tumor location and breast anatomy. The round-block method involves de-epithelizing and mobilizing breast tissue near the tumor, while the retroglandular technique includes dissecting tissue beneath the breast and muscle. After surgery, patients undergo standard oncological treatments, and follow-up includes regular assessments over five years. Participants undergo preoperative examinations including biopsies, imaging, and breast measurements, with data collected on tumor characteristics and patient health. Postoperative follow-up occurs at 4-6 weeks, 3 months, and then every 6 months for 5 years, involving photo documentation, breast measurements, software analysis, and quality of life questionnaires. Researchers monitor oncological safety, cosmetic outcomes, patient satisfaction, complications, and quality of life throughout the study period.
CONDITIONS
Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving 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 - 1 day
Participants undergo either round-block or retroglandular oncoplastic breast conserving surgery as part of their treatment.
1 surgical procedure (in-person)
Duration - Up to 5 years
Participants attend follow-up visits for photo documentation, body measurements, and quality of life assessments to monitor cosmetic results, satisfaction, and health status.
Visits at 4-6 weeks, 3 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