3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01964105
• Collaborator: Allergan (Industry)
• Enrollment: 100
• Location: 1
• Arms: 3
• Duration (Months): 54.4
• Patients Per Site Per Month: 1.8

Study Details

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	N/A

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
• 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: Nov 1, 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 Names: Vectra 3D
No Intervention: Standard Preoperative Evaluation Control Group: Patients will receive standard preoperative evaluation (2D imaging). Goal: 50 patients
Other: 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 Names: Vectra 3D

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol - Aug 27, 2014
• Informed Consent Form - Apr 27, 2017
• Statistical Analysis Plan - Aug 27, 2014

More Information

Additional Information:

• Click here for Washington University's study location.

Publications

• 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.
• 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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01964105
• Other Study ID Numbers: 201210065
• First Posted: Oct 17, 2013
• Last Update Posted: Dec 26, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Washington University School of Medicine: Hypomastia; Augmentation; Breast; 3D; Breast Q

Study Results

Participant Flow

Arm/Group Title	Standard Preoperative Evaluation	Non-Randomized Cohort: 3D Imaging	3D Imaging Simulation
Arm/Group Description	Control Group: Patients will receive standard preoperative evaluation (2D imaging). Goal: 50 patients	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	Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients 3D Imaging
Period Title: Overall Study
STARTED	15	75	10
COMPLETED	13	62	10
NOT COMPLETED	2	13	0

Baseline Characteristics

Arm/Group Title	3D Imaging Simulation	Standard Preoperative Evaluation	Non-Randomized Cohort: 3D Imaging	Total
Arm/Group Description	The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation.	The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated.	Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention.	Total of all reporting groups
Overall Participants	10	13	62	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.3 (23.1)	40.2 (11)	35.8 (8.2)	37.2 (8.0)
Sex/Gender, Customized (Count of Participants)
Female	10 100%	13 100%	62 100%	85 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%	13 100%	62 100%	85 100%
Volume of Breast (cubic centimeters (cc)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cubic centimeters (cc)]	494.5 (93)	503.4 (113.1)	420 (119.3)	441 (120.5)
BREAST-Q (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	63.6 (18.6)	70.1 (21.5)	64.8 (19.3)	64.6 (19.1)

Outcome Measures

1. Primary Outcome

Title	Breast Q Augmentation Module
Description	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.
Time Frame	up to 6 months postop visit.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Preoperative Evaluation	3D Imaging Simulation	Non-Randomized Cohort: 3D Imaging
Arm/Group Description	Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients 3D Imaging	Control Group: Patients will receive standard preoperative evaluation (2D imaging). Goal: 50 patients	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
Measure Participants	13	10	62
Mean (Standard Deviation) [units on a scale]	494.5 (93)	503.4 (113.1)	420 (119.3)

Adverse Events

Time Frame	6 months (entire study period)
Adverse Event Reporting Description	Adverse events were collected as defined by clinicaltrials.gov
Arm/Group Title	Standard Preoperative Evaluation		3D Imaging Simulation		Non-Randomized Cohort: 3D Imaging
Arm/Group Description	Patients undergo standard tissue-based planning. They were randomized to this intervention.		Patient undergo three-dimensional simulation of their breast augmentation. They were randomized to this intervention.		Patient undergo three-dimensional simulation of their breast augmentation. They sought this intervention (ie. not randomized).
All Cause Mortality
	Standard Preoperative Evaluation		3D Imaging Simulation		Non-Randomized Cohort: 3D Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/10 (0%)		0/62 (0%)
Serious Adverse Events
	Standard Preoperative Evaluation		3D Imaging Simulation		Non-Randomized Cohort: 3D Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/10 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Standard Preoperative Evaluation		3D Imaging Simulation		Non-Randomized Cohort: 3D Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/13 (0%)		0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.