This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.
CHU de Besançon
Besançon, France
Clinique Saint Antoine
Bois-Guillaume, France
CHU Pellegrin
Bordeaux, France
Institut Bergonie
Bordeaux, France
Pole de Sante de Leonard de Vinci
Chambray-lès-Tours, France
Hopital Henri Mondor
Créteil, France
Centre Hospitalier La Croix Rousse
Lyon, France
Hopital Edouard Herriot
Lyon, France
CHR Marseille Conception
Marseille, France
Institut Paoli Calmettes
Marseille, France
...and 13 more locations
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
Time frame: 1 year
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
Time frame: 1 year
Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.
Time frame: 1 year
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