Reduction of Breast Enlargement Using the Da Vinci Xi Robot
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ramsay Générale de Santé
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Number of Visible Scare
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Number of Visible Scare
Time Frame: 3 months
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.
Secondary Outcomes
- Intensity of Back Pain(3 months)
- Efficacity of the reduction (weight)(day of surgery)
- Skin retraction(at 3 months)