Clinical trial NCT05822115: Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
Official title: Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Reduction
Lead sponsor: Groupe Hospitalier Nord-Essonne
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Photography of the scar
timeFrame: at 3 months
Secondary outcomes:
measure: Scar assessment
timeFrame: at 3 weeks
measure: Resection weight
timeFrame: at 0 day
measure: Photography of Areola
timeFrame: at 3 weeks, 3 months and 1 year
measure: Scar lenght
timeFrame: at 3 weeks, 3 months and 1 year
measure: Blood loss
timeFrame: at 1 day
measure: Pain scale
timeFrame: at 3 weeks, 3 months and 1 year
measure: Satisfaction scale
timeFrame: at 3 weeks, 3 months and 1 year
measure: Cancer
timeFrame: at day 0
measure: Macroeconomic impact
timeFrame: at 1 year
measure: Scar thickness
timeFrame: at 3 weeks, 3 months and 1 year
Other outcomes:
Locations:
city: Longjumeau
country: France
facility: Dr Eric DUNET
Study officials:
References: