Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2017-08-15
2017-12-31
Brief Summary
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Detailed Description
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"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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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LMD
Physician uses LMD during procedure.
LMD
Physician uses LMD to measure defect during procedure.
Interventions
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LMD
Physician uses LMD to measure defect during procedure.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
Yes
Sponsors
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Boehringer Labs LLC
INDUSTRY
Responsible Party
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Locations
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Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Denne, MD
Role: primary
Tatyan Clarke, MD
Role: primary
Ian Soriano, MD
Role: primary
David Wernsing, MD
Role: backup
Other Identifiers
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LMD-1
Identifier Type: -
Identifier Source: org_study_id