Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03234855 |
| Other study ID # |
LMD-1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
July 27, 2017 |
| Last updated |
July 27, 2017 |
| Start date |
August 15, 2017 |
| Est. completion date |
December 31, 2017 |
Study information
| Verified date |
July 2017 |
| Source |
Boehringer Labs LLC |
| Contact |
Allen A Orr, BS |
| Phone |
484-931-2314 |
| Email |
aorr[@]boehringerlabs.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring
device.
Description:
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:
"Underestimating the defect size may lead to choosing a prosthetic that is too small, thus
increasing the risk of hernia recurrence." In order to aid surgeons in more accurately
measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring
device. This study aims to obtain feedback from surgeons on the usefulness and design of the
device.
