Clinical Trial

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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Record status
This record was last updated April 21, 2020 (before its estimated April 5, 2022 completion). Its status may not reflect the trial's current state.
Summary
The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries. According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-04-15.
Trial Details
NCT Number NCT04349527
Lead Sponsor National Institute of Oncology, Hungary
Conditions Breast Cancer, Quality of Life, Patient Satisfaction
Enrollment 242 participants
Start Date 2020-04-18
Primary Completion 2022-04-05 (estimated)
Study Completion 2027-04-05 (estimated)
Updated on ClinicalTrials.gov 2020-04-21