Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery (R-HTM-R)

Groupe Hospitalier Nord-Essonne

Status

Enrolling

Conditions

Breast Reduction

Treatments

Device: Reduction of breast hypertrophy by means of laparoscopic

Study type

Interventional

Funder types

Other

Identifiers

NCT05822115

2022-A01278-35

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.