Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction (MARCI)

Gustave Roussy

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Device: Da Vinci Robot Xi; Procedure: Mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02673268

2015-A00745-44

2015/2250 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Patients with breast cancer

Experimental group

Treatment:

Procedure: Mastectomy

Device: Da Vinci Robot Xi