Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Study Overview
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Brief Summary
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Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

Detailed Description
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Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women. The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary halo of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular. The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.

Official Title
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Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Conditions
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Breast Hypertrophy

Intervention / Treatment
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* Procedure: Robot Breast reduction surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over the age of 18 Category 1 or 2 according to the classification of Regnault Breast size cup c or more Areola looking in front, ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position) Expected correction of ptosis by half with reduction of 1 to 3 cup sizes Good quality thick skin Affiliated patient or beneficiary of a social security scheme Patient requesting breast reduction Patient who signed free and informed consent Exclusion Criteria: Areola look down; point A more than 25 cm Ptose greater than and equal to 8 cm Thin skin Smoker Patient on anti-coagulant Patient participating in another clinical study Protected patient: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, lactating woman

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot Reduction<br>The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm . | Procedure: Robot Breast reduction surgery<br>* Breast reduction surgery, using a robot by removing a breast disc at the base<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Visible Scare | The main judgment criterion for the scar balance will be a photograph of the breasts at 3 months to describe the number of visible scars. Aspect and position. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacity of the reduction (weight) | - The weight of the exeresis (more than 300g per side which corresponds according to calculation to a gland disc about 2 cm thick on an extended conical breast of 13cm for the base) | day of surgery | 
| Intensity of Back Pain | The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described | 3 months | 
| Skin retraction | - Post-operative skin retraction | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reduction, perimammary