3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

Not Applicable

Completed

• Conditions: Hypomastia; Primary Breast Augmentation
• Interventions: Device: 3D Imaging

• Registration Number: NCT01964105
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-17
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Results First Submitted: 2017-10-05
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Results First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Age 18 years or older
• Scheduled for elective breast augmentation cosmetic procedure.

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Exclusion Criteria

• Breast reconstruction for malignancy
• Cognitively unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Imaging Simulation	3D Imaging	Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients
Non-Randomized Cohort: 3D Imaging	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

West County Plastic Surgeons of Washington University; 🇺🇸 Saint Louis, Missouri, United States