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临床试验/NCT01945463
NCT01945463已完成不适用

The Effect of Breast Augmentation on the Quality of Echocardiography Test

Hadassah Medical Organization0 个研究点目标入组 4 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
主要终点
Proportion of women in which the breast implant will affect the quality of the Echo test.

研究概览

简要总结

Breast augmentation surgery is currently the most common elective plastic surgery performed in the US. With regards to the surgical technique, there are 4 incisional sites available for breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar, inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast tissue), submuscular (underneath the Pectoralis Major), or "dual-plane" (combination of both) manner.

Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation of cardiac structure and function. Its use has increased dramatically in the last decades. We have encountered three women with congenital heart disease who have undergone breast augmentation, and their echocardiographic images were significantly limited after the implantation. There is only one case report in the medical literature suggesting that breast implants interfere with echocardiographic views .

The underlying physical property of the silicone breast implants that causes interference with the ultrasound beam during echocardiographic examination is not known and has not been studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and unrevealing despite increase in gain or change in the ultrasound wave's frequency.

Many women elect breast augmentation for cosmetic reasons. Women with congenital heart disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire augmentation accordingly.

Knowledge of the extent of impairment of breast implants to the echocardiographic examination is important for few reasons:

  1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation should be consulted as to the limitation of the echocardiographic examination following the procedure.
  2. Women without heart disease considering breast augmentation should be informed of potential echocardiographic interference, if echocardiography be needed in the future,
  3. Different surgical techniques may cause different masking effect.
  4. Different implants size and shape may cause different masking effect.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation

排除标准

  • Unwillingness to participate.

结局指标

主要结局

Proportion of women in which the breast implant will affect the quality of the Echo test.

时间窗: one month

The women will be gone through two Echo tests, the first before the operation and the second six weeks after the operation. The physician will compare the two tests.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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