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Completed

NCT Number: NCT01964105

3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West County Plastic Surgeons of Washington University

St Louis, Missouri, 63141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D imaging

Device

Other names: Vectra 3D

Primary outcomes

  1. Breast Q Augmentation Module

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Allergan

Registry information

Official study title

3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery: Does 3D Improve Patient Reported Outcomes in Primary Breast Augmentation?

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2013
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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