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

Phase 2

• Conditions: Breast Cancer
• Interventions: Procedure: Mastectomy; Device: Da Vinci Robot Xi

• Registration Number: NCT02673268
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with breast cancer	Da Vinci Robot Xi	-
Patients with breast cancer	Mastectomy	-

Primary Outcome Measures

Name	Time	Method
Rate of necrosis	Assessed up to 1 year

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus; 🇫🇷 Villejuif, Val de Marne, France