Clinical trial NCT03715738: MEasurement by a Numerical Approach of BREAst Volume
Official title: MEasurement by a Numerical Approach of BREAst Volume MENABREA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Asymmetry, 3D
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-10-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: association between weight and volume adjusted to the density of the gland measured by electronic palpation
timeFrame: one year
Secondary outcomes:
measure: association between weight and volume adjusted to the density of the gland estimated by manual palpation
timeFrame: one year
measure: comparison of models 1 and 2
timeFrame: one year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
state: Maine Et Loire
Study officials:
References: