Laparoscopic Measuring Device Usability Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Physician Feedback
研究概览
简要总结
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.
详细描述
In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that:
"Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors."
An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation:
"Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions."
While a smaller mesh size can also be problematic:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with hernia defect that requires laparoscopic measurement
排除标准
- 未提供
结局指标
主要结局
Physician Feedback
时间窗: 6 months
Physician forms opinion on usefulness and design of LMD
次要结局
未报告次要终点
