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Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Sponsor: National Institute of Oncology, Hungary
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.
Official title: Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries. Response-adaptive (RAR) Prospective Randomised, Comperative Clinical Study
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
242
Start Date
2020-04-18
Completion Date
2027-04-05
Last Updated
2020-04-21
Healthy Volunteers
Yes
Interventions
Round-block Oncoplastic Breast Conserving Surgeries
We de-epithelize the gap between the double round-lines, and we dissect the dermis from the best localization where we can reach the tumor. If the tumor located close to the skin then we are not performing de-epithelization, we excise it with the skin. We mark every wall of the tumor bed with clips. We dissect the surrounding parenchyma- so called parenchyma pillars- from the pectoral fascia and the skin, and we mobilize it. The line under the skin means, the layer under the subcutis, above the superficial fascia, so gives appropriate blood supply to the skin. After this the incision line should be placed 5 mm from the outer round line, so a dermis pillar should be left, and the skin is dissected from the parenchyma as needed. The outer round line should be tightened with a non-absorbable running Benelli suture to fit the areola then interrupted sutures placed to make tensionless the running intracutaneous suture.
Retroglandular Oncoplastic Breast Conserving Surgeries
We incise the skin slightly lateral in the IMF, around 7 cm long. We dissect with electrocauther the parenchyma with the pectoral fascia from the pectoralis major muscle at least until the mamilla. We incise the fascia along with the parenchyma which contains the tumor and macroscopically 10 mm safe zone. If the tumor is palpable, we turn the parenchyma slightly inside-out, if not, we localize it at the maximum measurement detected according to the ROLL labeling. After marking the tumor bed, we directly adapt the surrounding parenchyma pillars with absorbable sutures, or inverting sutures, or if it requires, we adapt the tumor bed with so-called dual plane mobilization. After revision, we close the fascia with absorbable running suture over the Redon drain then subcutaneous running suture with absorbable suture and finally intracutaneous skin closure.
Locations (1)
National Institute of Oncology
Budapest, Hungary