Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life - Trial NCT04625621

Timeline & Enrollment

Primary Outcome

Evaluate the feasibility of the exclusive lipomodulin technique in breast reconstruction: Failure rate of the technique

Summary

Breast cancer is the leading female cancer in metropolitan France in terms of incidence and
 death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very
 important role and even if a conservative treatment is possible in the majority of cases,
 there is still an indication for mastectomy in about 30% of cases.
 
 Currently, only 30% of women who have undergone a mastectomy choose reconstruction.
 
 The primary objective of breast reconstruction from a surgical point of view is to leave as
 few aesthetic and functional after-effects as possible while meeting the personal wishes of
 each woman according to her morphological, tissue and vascular characteristics.
 
 There are currently 2 major surgical procedures for breast reconstruction: breast implant
 reconstructions and autologous reconstructions.
 
 Breast reconstruction by prosthesis is the simplest and most widely used technique but, the
 controversies concerning implants with the PIP breast prostheses scandal in 2010 and more
 recently the anaplastic lymphoma scandal have tarnished the image of this type of
 reconstruction.
 
 Alternatives to breast implants have been developed: autologous reconstructions using first
 pedicled tissue flaps, then free flaps, techniques that allow a more natural, more
 satisfactory aesthetic result with an evolution that follows the patient's own morphology but
 requiring specific training in microsurgery and not without postoperative complications.
 
 Since 1999, the investigators have witnessed the evolution of another autologous technique,
 that of lipomodulin. Initially used to improve the results of reconstructions and the
 aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction
 technique. Easily reproducible and offering several advantages, reconstruction by exclusive
 lipomodulin is increasingly appreciated by patients.
 
 However, this increasingly practiced technique presents specific problems and this is what
 the investigators want to evaluate in this study.
 
 The main objective of this study is to evaluate the practices within our establishment
 regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The
 secondary objectives are the evaluation of the cosmetic result and the quality of life of
 these patients after this type of reconstruction.

ICD-10 Classifications