Breast Hypertrophy
Conditions
Keywords
breast reduction, perimammary
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.
Interventions
PROCEDURERobot Breast reduction surgery
Breast reduction surgery, using a robot by removing a breast disc at the base
Sponsors
Hôpital Privé d'Antony - Dr Dunet
Ramsay Générale de Santé
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Visible Scare | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacity of the reduction (weight) | day of surgery | \- 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) |
| Intensity of Back Pain | 3 months | The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described |
| Skin retraction | at 3 months | \- Post-operative skin retraction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visible scare number | 1 year | number of visible scare based on photos analysis |
Countries
France
Contacts
Primary ContactJean François OUDET
Backup ContactMH barba
Outcome results
None listed