Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

European Institute of Oncology58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Prepectoral reconstructionPROCEDURE

Prepectoral breast reconstruction

Submuscolar reconstructionPROCEDURE

Submuscolar breast reconstruction

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

European Institute of Oncology

Milan, Italy

Outcomes

Primary Outcomes

Satisfaction assessed by the BREAST-Q

The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

Time frame: 1 year

Secondary Outcomes

Immediate complications rate

Compare post operative complications

Time frame: 1 month

Short term complications rate

Compare short term post operative complications

Time frame: 6 months

Long term complications rate

Compare long term post operative complications

Time frame: 24 months

Percentage of capsular contracture

Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers

Time frame: 1 year

Data from ClinicalTrials.gov

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