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OpenTrials
Completed

NCT Number: NCT03715738

MEasurement by a Numerical Approach of BREAst Volume

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, Maine Et Loire, 49933, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arm 1 : Creaform3D + MyotonPRO

Other

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.

Primary outcomes

  1. association between weight and volume adjusted to the density of the gland measured by electronic palpation

    Time frame: one year

    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.

Secondary outcomes

  1. association between weight and volume adjusted to the density of the gland estimated by manual palpation

    Time frame: one year

    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.

  2. comparison of models 1 and 2

    Time frame: one year

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

MEasurement by a Numerical Approach of BREAst Volume MENABREA

Acronym: MENABREA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2018
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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