Hypomastia, Primary Breast Augmentation
Conditions
Keywords
Hypomastia, Augmentation, Breast, 3D, Breast Q
Brief summary
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share with images how one could look after one's procedure. The patient's assessment will be collected using the Breast Q, an objective questionnaire that captures patient satisfaction with breast augmentation.
Detailed description
Consultation for primary breast augmentation involves clear communication between patient and surgeon to select the implant and manage expectations. Tissue-based planning strategies rely on tissue characteristics and measurements to produce safe and reproducible aesthetic outcomes. The implementation of sizers in the preoperative consultation and a greater emphasis on patient aesthetic goals have also proven to be favorable strategies. Recently, many plastic surgeons have started to incorporate three-dimensional (3D) photography and computer simulation into their preoperative consultation process. The accuracy of computer simulation for volume assessment of breast augmentation is reportedly ≥90%, and patients demonstrate a preference for consultations involving simulation.Support for computer simulation, however, is not unanimous. Quantitative analyses, prospective study designs, and utilization of validated health-related quality of life metrics have been recommended to more thoroughly scrutinize implant selection systems and outcomes in aesthetic surgery.Mammometrics yields numerical data useful for quantifying changes in breast morphology after breast reduction, reconstruction with implants, and augmentation. The BREAST-Q represents the most comprehensive and quantitative method for patient self-assessment following breast surgery, and has gained traction as a patient-reported outcomes instrument for breast augmentation. To date, there are no studies that focus on the impact of simulation on patient-reported outcomes in breast augmentation, as measured with the validated BREAST-Q. Furthermore, there is minimal data examining correlations between patient-reported outcomes and mammometrics. The purpose of this study was to conduct a prospective, clinical trial to evaluate the impact of 3D imaging and simulation used during the preoperative consultation on postoperative patient-reported outcomes and quantitative changes in breast morphology. We hypothesized that computer simulation would facilitate patient education and surgical planning, thus leading to quantitatively higher patient-reported outcomes.
Interventions
DEVICE3D Imaging
Sponsors
Allergan
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Scheduled for elective breast augmentation cosmetic procedure.
Exclusion criteria
* Breast reconstruction for malignancy * Cognitively unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Q Augmentation Module | up to 6 months postop visit. | BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D Imaging Simulation The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation. | 10 |
| Standard Preoperative Evaluation The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated. | 13 |
| Non-Randomized Cohort: 3D Imaging Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention. | 62 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 13 | 0 |
Baseline characteristics
| Characteristic | 3D Imaging Simulation | Standard Preoperative Evaluation | Non-Randomized Cohort: 3D Imaging | Total |
|---|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 23.1 | 40.2 years STANDARD_DEVIATION 11 | 35.8 years STANDARD_DEVIATION 8.2 | 37.2 years STANDARD_DEVIATION 8 |
| BREAST-Q | 63.6 units on a scale STANDARD_DEVIATION 18.6 | 70.1 units on a scale STANDARD_DEVIATION 21.5 | 64.8 units on a scale STANDARD_DEVIATION 19.3 | 64.6 units on a scale STANDARD_DEVIATION 19.1 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 10 Participants | 13 Participants | 62 Participants | 85 Participants |
| Sex/Gender, Customized Female | 10 Participants | 13 Participants | 62 Participants | 85 Participants |
| Volume of Breast | 494.5 cubic centimeters (cc) STANDARD_DEVIATION 93 | 503.4 cubic centimeters (cc) STANDARD_DEVIATION 113.1 | 420 cubic centimeters (cc) STANDARD_DEVIATION 119.3 | 441 cubic centimeters (cc) STANDARD_DEVIATION 120.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 | 0 / 62 |
| other Total, other adverse events | 0 / 10 | 0 / 13 | 0 / 62 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 | 0 / 62 |
Outcome results
Primary
Breast Q Augmentation Module
BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.
Time frame: up to 6 months postop visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Preoperative Evaluation | Breast Q Augmentation Module | 494.5 units on a scale | Standard Deviation 93 |
| 3D Imaging Simulation | Breast Q Augmentation Module | 503.4 units on a scale | Standard Deviation 113.1 |
| Non-Randomized Cohort: 3D Imaging | Breast Q Augmentation Module | 420 units on a scale | Standard Deviation 119.3 |