Laparoscopic Measuring Device Usability Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Physician Feedback
Study Overview
Brief Summary
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.
Detailed 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:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients with hernia defect that requires laparoscopic measurement
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Physician Feedback
Time Frame: 6 months
Physician forms opinion on usefulness and design of LMD
Secondary Outcomes
No secondary outcomes reported