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Recruiting NCT02781870

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

Trial Parameters

Condition Hernia
Sponsor Algemeen Ziekenhuis Maria Middelares
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2016-05-09
Completion 2026-12
All Conditions
Interventions
LiquiBand Fix8 glue fixationNo-fixation

Brief 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.

Eligibility Criteria

Inclusion Criteria: * adult patients presenting with primary unilateral inguinal hernia * patients planed for a laparoscopic repair Exclusion Criteria: * Age below 18 years * recurrent or incarcerated hernias * open hernia repair and bilateral hernias * concomitant repair of another kind of abdominal hernia * combined surgical procedures * no informed consent * pregnant women * ASA score 4 or more * contra-indications for MRI scans.

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