Breast Reduction
Conditions
Brief summary
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy. This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.
Detailed description
Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects. On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy. Ultimately, the results of this study may serve as a basis for further research by proposing: * Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar. * A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.
Interventions
DEVICEReduction of breast hypertrophy by means of laparoscopic
The research procedure is a breast reduction performed by means of laparoscopic surgery. The project consists of removing a disc from the breast at the level of the base, thus causing peripheral skin slackening of 2 to 3 cm but circular. Both breasts are usually operated on at the same time. In case of asymmetry, only one side will be treated.
Sponsors
Groupe Hospitalier Nord-Essonne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Women over the age of 18. * Category 1 or 2 according to the Regnault classification. * C cup breast size or larger. * Areola looks ahead i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm. * Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position). * Expected correction of half ptosis with decrease of 1 to 3 cup sizes. * Patient has good quality thick skin. * Social security scheme. * Patient requesting breast reduction. * Patient having signed the free and informed consent. Non inclusion criteria : * Areola look down; point A more than 25 cm. * Ptosis greater than or equal to 8 cm. * Thin skin. * Smoker. * Patient under effects of anti-coagulant. * Patient participating in another clinical study. * Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. * Pregnant, lactating woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photography of the scar | at 3 months | centimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resection weight | at 0 day | Resection weight |
| Photography of Areola | at 3 weeks, 3 months and 1 year | Centimeter |
| Scar lenght | at 3 weeks, 3 months and 1 year | Centimeter |
| Blood loss | at 1 day | the haemoglobin (hb) level |
| Scar assessment | at 3 weeks | number of scars |
| Satisfaction scale | at 3 weeks, 3 months and 1 year | 0 (dissatisfied) to 10 (satisfied) |
| Cancer | at day 0 | presence or absence |
| Macroeconomic impact | at 1 year | length of hospital stay, duration of surgery |
| Scar thickness | at 3 weeks, 3 months and 1 year | Centimeter |
| Pain scale | at 3 weeks, 3 months and 1 year | 0 (no pain) to 10 (very intense pain) |
Countries
France
Contacts
Primary ContactEric Dr DUNET, Chirurgien
Backup ContactJérôme Mr KOZLOWSKI, Directeur Innovation Recherche
Outcome results
None listed