Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
NCT ID: NCT02673268
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2015-11-25
2020-11-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with breast cancer
Mastectomy
Da Vinci Robot Xi
Interventions
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Mastectomy
Da Vinci Robot Xi
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
70 Years
FEMALE
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy Cancer Campus
Villejuif, Val de Marne, France
Countries
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Central Contacts
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Facility Contacts
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Benjamin Sarfati, MD
Role: primary
Stefan Michiels, PhD
Role: backup
References
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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.
Other Identifiers
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2015/2250
Identifier Type: OTHER
Identifier Source: secondary_id
2015-A00745-44
Identifier Type: -
Identifier Source: org_study_id