Breast Cancer
Conditions
Brief summary
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis. The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm. The aim is also to study the rate of complications, cosmetic results and quality of life.
Interventions
PROCEDUREMastectomy
DEVICEDa Vinci Robot Xi
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery: * Disease located more than 2cm of the areola on the clinical and paraclinical evaluation * Patients with indication of total mastectomy * Patients looking for immediate reconstruction 3. In case of prophylactic surgery * Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system
Exclusion criteria
1. Patients with a high risk of skin necrosis 2. Planned post operative radiotherapy 3. Patients with an historic of breast surgery on the side that needs to be operated 4. Pregnant or breastfeeding women 5. Persons deprived of liberty 6. Persons not able to undergo medical follow up due to geographical, social or psychic reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of necrosis | Assessed up to 1 year |
Countries
France
Contacts
Primary ContactBenjamin Sarfati, MD
Backup ContactStefan Michels, PhD
Outcome results
None listed