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

Recruiting now · Not applicable

Conditions studied: Hernia, Recurrence

In brief

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.

Key facts

Study ID

NCT02781870

Run by

Algemeen Ziekenhuis Maria Middelares

People needed

100

Starts

2016-05-09

Expected to finish

2027-08-01

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients presenting with primary unilateral inguinal hernia
• patients planed for a laparoscopic repair

You may not qualify if…

• 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.

Where it is running

• AZ Maria Middelares — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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