Status:
RECRUITING
Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Lead Sponsor:
National Institute of Oncology, Hungary
Conditions:
Breast Cancer
Quality of Life
Eligibility:
FEMALE
18-65 years
Brief 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...
Detailed Description
Introduction In the last four decades of oncological breast surgery, based on Umberto Veronesi and Bernard Fisher's prospective comparative studies, organ conservation became highly significant in the...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
April 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 5 2027
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04349527
Start Date
April 18 2020
End Date
April 5 2027
Last Update
April 21 2020
Active Locations (1)
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1
National Institute of Oncology
Budapest, Hungary, 1122