Clinical trial NCT04597515: Reduction of Breast Enlargement Using the Da Vinci Xi Robot
Official title: Reduction of Breast Enlargement Using the Da Vinci Xi Robot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Hypertrophy
Keywords: breast reduction
perimammary
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Hôpital Privé d'Antony - Dr Dunet
First posted: 2020-10-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Visible Scare
timeFrame: 3 months
Secondary outcomes:
measure: Efficacity of the reduction (weight)
timeFrame: day of surgery
measure: Intensity of Back Pain
timeFrame: 3 months
measure: Skin retraction
timeFrame: at 3 months
Other outcomes:
measure: Visible scare number
timeFrame: 1 year
Locations:
city: Antony
country: France
facility: Hôpital Privé d'Antony
state: IDF
Study officials:
affiliation: Ramsay santé
name: Eric Dunet, Dr
role: PRINCIPAL_INVESTIGATOR
References: