Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-09-30

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.

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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.

Conditions

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Breast Reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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treated group

Breast reduction

Group Type EXPERIMENTAL

Reduction of breast hypertrophy by means of laparoscopic

Intervention Type DEVICE

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.

Interventions

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Reduction 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.

Intervention Type DEVICE

Other Intervention Names

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R-HTM-R

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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes