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临床试验/NCT03234855
NCT03234855Unknown不适用

Laparoscopic Measuring Device Usability Study

Boehringer Labs LLC3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月15日最近更新:
适应症

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

研究者

发起方
Boehringer Labs LLC
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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