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.
adult patients presenting with primary unilateral inguinal hernia
patients planed for a laparoscopic repair
Age below 18 years
recurrent or incarcerated hernias
open hernia repair and bilateral hernias
concomitant repair of another kind of abdominal hernia
Parallel
LiquiBand Fix8 glue fixation
Procedure/SurgeryPatients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
No-fixation
Procedure/SurgeryPatients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.
visualization of mesh surface
Visualization of the mesh surface at 12 months postoperative observed with MRI scan rate after laparoscopic repair of unilateral inguinal hernias using the 3D-Endolap visible mesh with or without LiquiBand® Fix 8™ glue fixation.
visualization of mesh surface
Visualization of the mesh surface at 1 month postoperative observed with MRI scan
recurrence of inguinal hernia
Recurrence rate of inguinal hernia measured at 1 month, 12, 36 and 60 months clinically of by ultrasound as indicated.
Quality of Life assessment
Quality of Life assessment with the EuraHS QoL
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Algemeen Ziekenhuis Maria Middelares
Lead sponsor
Duomed
Collaborator
