Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
MARCI
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Nov 2015
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedOctober 12, 2017
October 1, 2017
3.9 years
February 1, 2016
October 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of necrosis
Assessed up to 1 year
Study Arms (1)
Patients with breast cancer
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with a high risk of skin necrosis
- Planned post operative radiotherapy
- Patients with an historic of breast surgery on the side that needs to be operated
- Pregnant or breastfeeding women
- Persons deprived of liberty
- Persons not able to undergo medical follow up due to geographical, social or psychic reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gustave Roussy Cancer Campus
Villejuif, Val de Marne, 94805, France
Related Publications (1)
Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
PMID: 29959612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2016
First Posted
February 3, 2016
Study Start
November 25, 2015
Primary Completion
November 1, 2019
Study Completion
November 1, 2020
Last Updated
October 12, 2017
Record last verified: 2017-10