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临床试验/NCT01964105
NCT01964105已完成不适用

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

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Breast Q Augmentation Module

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

3D Imaging Simulation

Experimental

Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients

干预措施: 3D Imaging (Device)

Standard Preoperative Evaluation

No Intervention

Control Group: Patients will receive standard preoperative evaluation (2D imaging).

Goal: 50 patients

Non-Randomized Cohort: 3D Imaging

Other

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

干预措施: 3D Imaging (Device)

结局指标

主要结局

Breast Q Augmentation Module

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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