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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Reduction
• Intervention / Treatment: Device: Reduction of breast hypertrophy by means of laparoscopic

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Dr DUNET, Chirurgien; Phone Number: +33607812501; Email: ericdunet@gmail.com
• Study Contact Backup: Name: Jérôme Mr KOZLOWSKI, Directeur Innovation Recherche; Phone Number: +33664542963; Email: n.goumas@ghne.fr

Study Locations

• France
  • Longjumeau, France, 91160
    • Recruiting
    • Dr Eric DUNET
    • Contact: Dr Eric Dunet Principal investigator; Phone Number: ericdunet@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treated group; Breast reduction

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.; Other Names: R-HTM-R

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Nord-Essonne

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 2022-A01278-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No