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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorNational Institute of Oncology, Hungary

About this trial

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 criteria

Qualifiers

- 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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Round-block Oncoplastic Breast Conserving Surgeries
  • Retroglandular Oncoplastic Breast Conserving Surgeries

Treatment groups

242 Participants
are divided into 2 treatment groups