Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT01964105
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.
Study:
NCT01964105
Study Brief:
Protocol Section:
NCT01964105