RecruitingNCT04349527

Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries

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

Sponsor

National Institute of Oncology, Hungary

Enrollment

242 participants

Start Date

Apr 18, 2020

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Quality of Life Patient Satisfaction

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing cosmetic outcomes, quality of life, and patient satisfaction between two breast-conserving surgical techniques used in early-stage breast cancer: the round-block technique and retroglandular (behind-the-gland) surgery. The goal is to understand which approach leads to better results for patients. **You may be eligible if:** - You are under 65 years old - You have early-stage breast cancer in one breast (tumor smaller than 3 cm) - You are a candidate for breast-conserving surgery (lumpectomy) rather than full mastectomy - You have not had previous breast surgery **You may NOT be eligible if:** - You do not wish to participate or attend follow-up visits - You are 65 or older, or in poor health with a life expectancy under 2 years - You have had another invasive cancer previously (except non-melanoma skin cancer) - You have had prior breast surgery or radiation to the breast or underarm - You end up needing a full mastectomy due to positive surgical margins Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERound-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.

PROCEDURERetroglandular 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.