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MEasurement by a Numerical Approach of BREAst Volume

NCT03715738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-30

No results posted yet for this study

Summary

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).

Conditions

  • Breast Asymmetry, 3D

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2023-04-18
Completion
2023-09-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715738 on ClinicalTrials.gov