Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Conditions
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Breast Reduction

Intervention / Treatment
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* Device: Reduction of breast hypertrophy by means of laparoscopic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treated group<br>Breast reduction | Device: Reduction of breast hypertrophy by means of laparoscopic<br>* 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.<br>* Other names: R-HTM-R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photography of the scar | centimeter | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar assessment | number of scars | at 3 weeks | 
| Resection weight | Resection weight | at 0 day | 
| Photography of Areola | Centimeter | at 3 weeks, 3 months and 1 year | 
| Scar lenght | Centimeter | at 3 weeks, 3 months and 1 year | 
| Blood loss | the haemoglobin (hb) level | at 1 day | 
| Pain scale | 0 (no pain) to 10 (very intense pain) | at 3 weeks, 3 months and 1 year | 
| Satisfaction scale | 0 (dissatisfied) to 10 (satisfied) | at 3 weeks, 3 months and 1 year | 
| Cancer | presence or absence | at day 0 | 
| Macroeconomic impact | length of hospital stay, duration of surgery | at 1 year | 
| Scar thickness | Centimeter | at 3 weeks, 3 months and 1 year |