Laparoscopic Measuring Device Study

• Conditions: Physician Feedback
• Interventions: Device: LMD

• Registration Number: NCT03234855
• Lead Sponsor: Boehringer Labs LLC

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:

"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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-27
• Last Update Submitted: 2017-07-27
• Study First Posted: 2017-07-31
• Last Update Posted: 2017-07-31
• Study Start: 2017-08-15
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients with hernia defect that requires laparoscopic measurement

Exclusion Criteria

• Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LMD	LMD	Physician uses LMD during procedure.

Primary Outcome Measures

Name	Time	Method
Physician Feedback	6 months	Physician forms opinion on usefulness and design of LMD

Trial Locations

Locations (3)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Bryn Mawr Hospital; 🇺🇸 Bryn Mawr, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States