Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

Study Overview
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Brief Summary
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Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

Detailed Description
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Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

Official Title
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Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

Conditions
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Mastectomy, Breast Reconstruction

Intervention / Treatment
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* Device: Robot-assisted
* Procedure: Not robot-assisted surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, Signed consent to participate, Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions) Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis, immediate breast reconstruction by autologous latissimus dorsi flap immediate breast reconstruction by latissimus dorsi flap and prosthesis, secondary breast reconstruction by latissimus dorsi flap Affiliation to, or beneficiary of, a social security scheme. Exclusion Criteria: Patient under 18, Pregnant woman or likely to be (without effective contraception) or breastfeeding, Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent, Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Phase III, non-randomized, monocentric, observational, prospective trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery<br>Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, | Device: Robot-assisted<br>* robot-assisted surgery<br>|
| Active Comparator: Non robotic surgery<br>Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, | Procedure: Not robot-assisted surgery<br>* Not robot-assisted surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postoperative early complications | To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-assisted, mini-invasive surgery