3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
NCT ID: NCT01964105
Last Updated: 2017-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-11-30
2017-05-16
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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3D Imaging Simulation
Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients
3D Imaging
Standard Preoperative Evaluation
Control Group: Patients will receive standard preoperative evaluation (2D imaging).
Goal: 50 patients
No interventions assigned to this group
Non-Randomized Cohort: 3D Imaging
Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.
Goal: 50 Patients
3D Imaging
Interventions
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3D Imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective breast augmentation cosmetic procedure.
Exclusion Criteria
* Cognitively unable to provide informed consent.
18 Years
FEMALE
No
Sponsors
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Allergan
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Terence M Myckatyn, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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West County Plastic Surgeons of Washington University
St Louis, Missouri, United States
Countries
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References
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Tepper OM, Unger JG, Small KH, Feldman D, Kumar N, Choi M, Karp NS. Mammometrics: the standardization of aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2010 Jan;125(1):393-400. doi: 10.1097/PRS.0b013e3181c4966e. No abstract available.
Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
Overschmidt B, Qureshi AA, Parikh RP, Yan Y, Tenenbaum MM, Myckatyn TM. A Prospective Evaluation of Three-Dimensional Image Simulation: Patient-Reported Outcomes and Mammometrics in Primary Breast Augmentation. Plast Reconstr Surg. 2018 Aug;142(2):133e-144e. doi: 10.1097/PRS.0000000000004601.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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Click here for Washington University's study location.
Other Identifiers
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201210065
Identifier Type: -
Identifier Source: org_study_id