Recruitment and participants
Prior to participant recruitment, the ethics committee of Regensburg University approved the study (Approval number: 20-1654-101). Patients with diagnosed breast asymmetry and a correction surgery at our institution (University Center for Plastic, Aesthetic, Hand and Reconstructive Surgery, Regensburg) in the years of 2008–2019 with either lipofilling or silicone implant were included in the study. Women who were minor, had epilepsy, were in a post-mastectomy state or patients with acquired breast asymmetry were excluded from the study. The data collection period was from March 2020 to July 2020. A compact overview of our patient collective is given in Table 1:
Table 1
Description of our patient collective
n = 34
|
Mean (± SD)
|
Range
|
Age (at time of data collection) [in years]
|
30 (± 5.8)
|
21–45
|
Age (at time of first breast surgery) [in years]
BMI (at time of last breast surgery) [in kg/m2]
Length of postoperative period [in years]
|
21 (± 5.6)
23.6 (± 4.1)
7 (± 3.3)
|
16–42
18–38
0.9–12
|
Cup Size
|
C
|
A-E
|
Scar quality (given a scale from 1 (best) to 3 (worst))
|
1.4 (± 0.6)
|
1–3
|
Number of surgery sessions
|
2 (± 1.2)
|
1–5
|
At the time of the first operation correcting breast asymmetry 10 of the 34 patients were minors. Half of the patients were treated with lipofilling and the other half with silicone implant augmentation. The cohort of patients with congenital breast asymmetry included five women with diagnosed Poland’s syndrome, fifteen patients with tuberous breast deformity and breast asymmetry, thirteen persons with Amazon’s syndrome and one woman with chest deformity.
Study design
Before participating, the patients received medical education about the study and signed an informed consent.
Following parameters were collected through the clinical examination: In addition, cup size (A/B/C/D/E) was determined by medical assessment. The scar quality was evaluated on a scale from 1–3 (hardly/moderate/highly visible scars). As body measurements can be an important predictor for female attractiveness [17], the patient was measured manually with a classic tape measure along the skin surface. The following distances were recorded: Sternal Notch to Nipple (SN–N), Inframammary Fold to Nipple (IMF–N), Upper Breast Pole to Nipple (UBP–N), Xiphoid to Nipple (Xi–N), Lateral Breast Pole to Nipple (LB–N), Inframammary Fold Length (IMF-Length) and Areola diameter (AD). The recorded distances are shown in Fig. 1. All measurements were performed as shortest distance along the skin surface.
Three-Dimensional Volumetry
The 3D breast volumetry was performed with the portable Vectra® H2 (Canfield Scientific, USA), which is frequently used in the literature [18–26]. The 3D model can be analysed in terms of breast volumes and various breast dimensions by using the BREASTsculptor® software, which is integrated into the programme. O'Connell et al. [20] conducted a validation study in 2018 using the Vectra® XT with a modified protocol and the anterior axillary line selected for the lateral breast boundary. The difference between users 1 and 2 was minimised by these precisely defined points [20]. We integrated these findings, so that the reference points were precisely defined in order to achieve the greatest possible reproducibility in our study:
(1) Sternal Notch (SN), (2) centre of the right clavicle (Cr), (3) centre of the left clavicle (Cl), (4) most cranial point of the right areola (Ar), (5) most cranial point of the left areola (Al), (6) right nipple (Nr), (7) left nipple (Nl), (8) end of right medial inframammary fold (MBr), (9) end of left medial inframammary fold (MBl), (10) end of right lateral inframammary fold (LBr), (11) end of left lateral inframammary fold (LBl), (12) most caudal point of the right inframammary fold (IMFr), (13) most caudal point of the left inframammary fold (IMFl)
Points (8) and (9) are seen as the medial border of the breast. They are more precisely defined as the respective point of the inframammary fold with the shortest distance to the linea mediana anterior. The lateral border of the breast is marked by points (10) and (11). As the appearance of the mamma varies greatly from woman to woman [27], depending on the shape of the breast, the inframammary folds can be very variable and might have a diffuse end [28], which makes reproduction of the present reference point inaccurate. The high inaccuracy of reference points was also criticised by O'Connell et al. [20]. They defined the lateral breast boundary as the anterior axillary line [20]. To use a reproducible reference point and to achieve uniformity with manual volumetry, we follow O'Connell et al. [20] and defined the point of the lateral breast boundary as the intersection of the anterior axillary line with a line through the nipple.
All images were taken at our institute, composited and analysed using Vectra® using Breast Sculpture®. The camera equipment includes a special positioning mat which precisely specifies the position of the patient and photographer for each of the three images. The 45° angle of the arms was checked with a goniometer. Additionally, a telescopic stick was used in order to support the patient holding the angle of the arms. The first and third images show the patient at a 45° angle from the right and left respectively. The second image is taken frontally. The Vectra® software then assembles a 3D model from the three captured images. In order to perform calculations on this image, 13 reference points are required. As the automatic detection of the reference points by the Vectra® software did not work as well as expected, the reference points were marked on the patient before the images were taken and then set manually accordingly in the software. This seems to be a common problem which is as well described by other researchers [19]. Following Eder et al. [29], we used the positive effects of pre-marking the reference points [29].
Patient-Related-Outcome Measures: Breast Q™ questionnaire
All participants answered the Breast Q™ questionnaire (Breast-Q Version 2.0©, Augmentation Modules Pre- and Postoperative Scales, German (DE) Version, The University of British Columbia, licensed for non-profit users by Memorial Sloan Kettering Cancer Center and translated by Mapi Research Trust, 2008). This is a standardised patient-reported outcome measures (PROM) on subjective quality of life developed by Pusic et. al. [30]. Over five years the Breast Q™ was validated with the help of about 3000 women [31]. It is therefore considered a clinically relevant standardised outcome evaluation instrument that meets psychometric criteria and assesses the patient's self-assessment according to a state-of-the-art system [31] and has recently been used by other researchers in similar studies [32, 33].
This study used the module requesting the patient’s satisfaction after breast surgery. It evaluates the satisfaction with the breast surgery outcome by means of eight questions with three possible answers for each: 1 = disagree; 2 = somewhat agree; 3 = completely agree. Using the enclosed transformation score, the sum for each module can be interpreted directly as a value between 0 (worst value) and 100 (best value) and thus also as satisfaction in percent.
Statistical analysis
The statistical evaluation was carried out with SPSS® Statistics Version 25.0.0. from IBM®. Using Spearman's correlation, all meaningful parameters were examined for a correlation with patient subjective outcome satisfaction. Spearman correlation was chosen, because either at least one parameter was ordinally scaled or there was at least one outliner. For a comparison between two groups the Mann-Whitney test was applied, because they did not show a normal distribution (Kolmogorov-Smirnov test and the Shiparo-Wilk test) for both groups. A significance level of 0.05 was considered. Simple calculations were carried out with the help of Microsoft® Excel Version 16.41.