Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation
Algemeen Ziekenhuis Maria Middelares
100 participants
May 9, 2016
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- adult patients presenting with primary unilateral inguinal hernia
- patients planed for a laparoscopic repair
Exclusion Criteria9
- 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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Interventions
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.
Locations(1)
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NCT02781870