UnknownNot Applicable

Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Italy58 participantsStarted 2019-09-03

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

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

What they're measuring

Satisfaction assessed by the BREAST-Q

Timeframe: 1 year

Trial details

NCT IDNCT05125991

SponsorEuropean Institute of Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

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