Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    58
  • sponsor
    European Institute of Oncology
Updated on 25 November 2021
breast surgery
mastectomy
breast reconstruction

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.

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.

Details
Condition cancer, breast, Breast Cancer, breast carcinoma, Breast Cancer Diagnosis
Treatment Prepectoral reconstruction, Submuscolar reconstruction
Clinical Study IdentifierNCT05125991
SponsorEuropean Institute of Oncology
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent
Not smokers
No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
BMI<30
CUP B-C (or mastectomy estimated weight less than 550gm)
Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)
No previous breast surgery
No previous breast irradiation
Breast Ptosis 1-2 according to Renault's classification
DCIS tumors
T1 T2 pN0 breast tumor with known favourable biologic features

Exclusion Criteria

Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
Positive sentinel node biopsy requiring complete axillary dissection
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