Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Breast Reduction Clinical Trial

— R-HTM-R  

Official title:

Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822115
• Other study ID #: 2022-A01278-35
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Nord-Essonne
• Contact: Eric Dr DUNET, Chirurgien
• Phone: +33607812501
• Email: ericdunet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reduction
• Hypertrophy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Dr Eric DUNET	Longjumeau

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Nord-Essonne

Country where clinical trial is conducted

France, 

Outcome

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