Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Recruiting · NCT04349527 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Oncology, Hungary
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- \- Under the age of 65, suffering from unilateral (cT\< 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection)
Exclusion criteria
- In case the patient does not volunteer for the examination or the follow-ups
- Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor
- Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
- Mastectomy performed due to positive resection margin
- Prior breast surgery (e.g. aesthetic surgery, breast lift) and/or radiotherapy on the breast or in the axilla
- Malignant tumor is not removed completely with pathological examination
- Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results
- Autoimmune diseases
- Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa
- Long-term steroid usage, which changed the skin's quality and structure
- Patient under foster care, or psychically non-cooperative patient
Where it is running
1 location listed.
- National Institute of Oncology - Budapest, Hungary