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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAlgemeen Ziekenhuis Maria Middelares

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators