Breast Cancer
Conditions
Brief summary
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
Detailed description
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated. The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice. Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.
Interventions
PROCEDUREPrepectoral reconstruction
Prepectoral breast reconstruction
PROCEDURESubmuscolar reconstruction
Submuscolar breast reconstruction
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent 2. Not smokers 3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders) 4. BMI\<30 5. CUP B-C (or mastectomy estimated weight less than 550gm) 6. Good subcutaneous layer (\>1cm on pinch test measured in upper/medial quadrant) 7. No previous breast surgery 8. No previous breast irradiation 9. Breast Ptosis 1-2 according to Renault's classification 10. DCIS tumors 11. T1 T2 pN0 breast tumor with known favourable biologic features
Exclusion criteria
1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality) 2. Positive sentinel node biopsy requiring complete axillary dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction assessed by the BREAST-Q | 1 year | The BREAST-Q survey is used to detect differences in patient satisfaction among the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate complications rate | 1 month | Compare post operative complications |
| Short term complications rate | 6 months | Compare short term post operative complications |
| Long term complications rate | 24 months | Compare long term post operative complications |
| Percentage of capsular contracture | 1 year | Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers |
Countries
Italy
Outcome results
None listed