3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

• ClinicalTrials.gov Identifier: NCT01964105
• Recruitment Status: Completed
• First Posted: October 17, 2013
• Results First Posted: December 26, 2017
• Last Update Posted: December 26, 2017
• Sponsor: Washington University School of Medicine
• Collaborator: Allergan
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypomastia; Primary Breast Augmentation	Device: 3D Imaging	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery: Does 3D Improve Patient Reported Outcomes in Primary Breast Augmentation?
• Study Start Date: November 2012
• Actual Primary Completion Date: May 16, 2017
• Actual Study Completion Date: May 16, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 3D Imaging Simulation; Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients	Device: 3D Imaging; Other Name: Vectra 3D
No Intervention: Standard Preoperative Evaluation; Control Group: Patients will receive standard preoperative evaluation (2D imaging). Goal: 50 patients
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	Device: 3D Imaging; Other Name: Vectra 3D

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Missouri

West County Plastic Surgeons of Washington University

Saint Louis, Missouri, United States, 63141

Sponsors and Collaborators

Washington University School of Medicine

Allergan

Investigators

• Principal Investigator: Terence M Myckatyn, MD, FACS; Washington University School of Medicine

  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Study Protocol  [PDF] August 27, 2014

Informed Consent Form  [PDF] April 27, 2017

Statistical Analysis Plan  [PDF] August 27, 2014

More Information

Additional Information:

Click here for Washington University's study location. 

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01964105
• Other Study ID Numbers: 201210065
• First Posted: October 17, 2013
• Results First Posted: December 26, 2017
• Last Update Posted: December 26, 2017
• Last Verified: November 2017

Keywords provided by Washington University School of Medicine:

Hypomastia; Augmentation; Breast; 3D; Breast Q