MEasurement by a Numerical Approach of BREAst Volume (MENABREA)

MEasurement by a Numerical Approach of BREAst Volume MENABREA

Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.

In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.

However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.

No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.

Primary objective :

To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).

Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).

Study Overview

• Status: Unknown
• Conditions: Breast Asymmetry, 3D
• Intervention / Treatment: Other: arm 1 : Creaform3D + MyotonPRO

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients referred for uni / bilateral breast reduction as part of an indication of surgical management.
• Major patients.
• Patients affiliated or beneficiaries of a social security scheme
• Patients who have signed prior informed consent.

Exclusion Criteria:

• Protected patients (pregnant, parturient and lactating women, persons deprived of their liberty by an administrative or judicial decision, persons undergoing psychiatric care under duress, minors, adults over the age of 18) legal protection measure or unable to express their consent).
• Patients unfit to understand the objectives or instructions of the study.
• Patients in an exclusion period relative to another interventional study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: arm 1 : Creaform3D + MyotonPRO; A clinical questionnaire is completed by the investigator (chest circumference, thorax turn, breast "measurements"). The breast density is assessed by the surgeon and scored from 1 to 5 (Likert scale) and then by the MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair during 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast. Intraoperatively, the weight of tissues removed is weighed (in grams), recorded in the observation notebook. In post-operative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D. Once this measurement is completed, participation in the study is complete

Other: arm 1 : Creaform3D + MyotonPRO; After inclusion,are carried out: estimation of the volume of the breast to be reduced with the 3D digital camera; measurement of breast density by Likert scale and MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair to be as still as possible over a period of 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast. In peroperative, the weight of tissues removed is weighed (in grams). The removed weight is recorded in the observation notebook. In postoperative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D. Once this measurement is completed, participation in the study is complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association between weight and volume adjusted to the density of the gland measured by electronic palpation	To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO). Primary judgment criterion: Coefficient associated with volume variation in the linear regression model (model 1) explaining weight by volume variation and density measured by electronic palpation.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association between weight and volume adjusted to the density of the gland estimated by manual palpation	To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5). Secondary judgment criterion 1: Coefficient associated with volume variation in the linear regression model (Model 2) explaining weight by volume variation and estimated density by manual palpation.	one year
comparison of models 1 and 2	Comparison of models 1 and 2 (estimated density by manual palpation or measured by electronic method), to see if one model is better than the other. Secondary judgment criterion 2: Akaike Criterion	one year

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 21, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A02018-47

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
• product manufactured in and exported from the U.S.: No