Breast Hypertrophy Clinical Trial
— R-HTM-ROfficial title:
Reduction of Breast Enlargement Using the Da Vinci Xi Robot
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.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Privé d'Antony | Antony | IDF |
Lead Sponsor | Collaborator |
---|---|
Ramsay Générale de Santé | Hôpital Privé d'Antony - Dr Dunet |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Visible scare number | number of visible scare based on photos analysis | 1 year | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Skin retraction | - Post-operative skin retraction | at 3 months |
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