About this trial
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
Qualifiers
adult patients presenting with primary unilateral inguinal hernia
patients planed for a laparoscopic repair
Disqualifiers
Age below 18 years
recurrent or incarcerated hernias
open hernia repair and bilateral hernias
concomitant repair of another kind of abdominal hernia
Trial design
Treatments tested in this trial
- LiquiBand Fix8 glue fixation
- No-fixation
Treatment groups
Sponsors and collaborators
Algemeen Ziekenhuis Maria Middelares
Lead sponsor
Duomed
Collaborator