Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
Condition: Breast Cancer; Mammaplasty
Study type: Interventional

Summary: 
      Methods for breast reconstruction after mastectomy vary from rather simple techniques using
      expanders and implants, local flaps alone or in combination with implants, to more complex
      methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983
      become golden standard in autologous breast reconstruction. The deep inferior epigastric
      perforator (DIEP)-flap, the very last improvement of TRAM flap, has been used in breast
      reconstruction after mastectomy and radiation therapy as the method of choice at the
      Department for Plastic Surgery at Hospital of Telemark since 2000.Transplantation of fat
      tissue by lipoinjections is an alternative method for partial breast reconstruction. In
      recent years, fat transplantation techniques have gained interest even for patients after
      mastectomy, as donor site morbidity and operative trauma seem to be less than when free flaps
      are used. Best results are obtained if the skin around mastectomy scar is pretreated with
      external expansion. The results of breast reconstruction with fat transplantation are
      promising, but have not been compared to microsurgical reconstruction of the breast in a
      scientific manner. The present project is designed to address clinical questions regarding
      efficiency and patient satisfaction of the two methods.
    

Detailed description: 
      When used for breast reconstruction on irradiated patients, breast implants can result in 50%
      or higher rate of complications included capsular contracture and implant rupture. For this
      reasons secondary breast reconstruction in irradiated patients is preferably done with
      autologous tissue.Reconstruction methods employing microvascular transfer of autologous
      tissue are time consuming having a long learning curve for surgeons. The present project aims
      to evaluate fat transplantation in combination with external tissue expansion (Brava method)
      as an alternative to microsurgical complexe methods.

      Hypothesis: Early complication/ drop out occur more frequently in fat transplantated
      patients.

      Methods: External tissue expanders (Brava, Brava, LLC 14221 SW 142nd St, Miami, FL 33186)
      will be used 3 weeks prior to reconstruction in order to enhance the volume and survival of
      fat cells. The investigators expect that each patient in the fat transplantation group will
      need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume
      and shape of the breast. The investigators expect 1-2 operative sessions of respectively 5-7
      and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during
      the first postoperative week) in the DIEP group is 5-10 %.

      Patients in the fat transplantation group experiencing poor compliance or early complications
      as well as patients with unsatisfactory results will be offered alternative methods of
      reconstruction such as superior or inferior gluteal perforator flap (SGAP or IGAP),
      Latissimus dorsi pedicled flap alone or in combination with implant. In some cases even
      simple implant reconstruction could be offered assuming that the quality of previously
      irradiated skin has been improved by fat transplants .

      Study design: Prospective cohort study

      Hypothesis: Reconstruction with BRAVA and fat transplantation is a good alternative to
      reconstruction with DIEP flap.

      Study variables: MRI-based volume estimates, anthropometric measurements, VAS scale (Breast-Q
      - questionnaire measuring patient-related outcome) and Telemark breast score evaluation
      through independent investigators

      Statistics: Power analysis determine that 25 patients are required in each group in this
      study considering 80 % power with 95 % significance and 40 % difference with regard to
      patient satisfaction and early complications.

      Follow-up: 6 months after DIEP reconstruction and 3 months after the second session of fat
      transplantation.

      Primary endpoint: assessment of early complications in both study groups

      Secondary endpoint: patient satisfaction with shape and symmetry of the breast, Satisfaction
      with psychosocial, psychological and sexual well-being, satisfaction with process of care,
      shape of the body and postoperative scars (Breast-Q).
    

Intervention name(s): Brava-group; DIEP-group
Intervention type(s): Procedure; Procedure
Intervention description(s): Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.; Microsurgical reconstruction by DIEPO method
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative study of two parallell cohorts (BRAVA and DIEP reconstruction methods).
Masking: None (Open Label)
Primary purpose: Treatment