Evaluation of the Effectiveness of Prepectoral Breast Reconstruction
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Prepectoral reconstruction Prepectoral breast reconstruction with Braxon dermal matrix |
Procedure: Prepectoral reconstruction
Prepectoral breast reconstruction
|
Active Comparator: Submuscular reconstruction Submuscolar breast reconstruction |
Procedure: Submuscolar reconstruction
Submuscolar breast reconstruction
|
Outcome Measures
Primary Outcome Measures
- Satisfaction assessed by the BREAST-Q [1 year]
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent
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Not smokers
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No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
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BMI<30
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CUP B-C (or mastectomy estimated weight less than 550gm)
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Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)
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No previous breast surgery
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No previous breast irradiation
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Breast Ptosis 1-2 according to Renault's classification
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DCIS tumors
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T1 T2 pN0 breast tumor with known favourable biologic features
Exclusion Criteria:
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Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
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Positive sentinel node biopsy requiring complete axillary dissection
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | European Institute of Oncology | Milan | Italy | 20141 |
Sponsors and Collaborators
- European Institute of Oncology
Investigators
- Principal Investigator: Francesca De Lorenzi, PhD, MD, European Institute of Oncology
- Principal Investigator: Paolo Veronesi, MD, European Institute of Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IEO 1002/