Clinical Trial

Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation

Recruiting
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Summary
This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and 12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of groin hernias. A total of 100 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the department of surgery will screen all eligible consecutive patients for inclusion in the study. They will inform all patients about the surgery and the follow-up with MRI scan thereafter.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2016-05-20; most recent amendment 2025-04-10.
Trial Details
NCT Number NCT02781870
Lead Sponsor Algemeen Ziekenhuis Maria Middelares
Collaborators: Duomed
Conditions Hernia, Recurrence
Enrollment 100 participants
Start Date 2016-05-09
Primary Completion 2026-12 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-04-11