Actively Recruiting
Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
585 weeks
Total Duration
On this page
Sponsors
A
Algemeen Ziekenhuis Maria Middelares
Lead Sponsor
D
Duomed
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients presenting with primary unilateral inguinal hernia
- Patients planned for laparoscopic repair
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
Research Team
F
Filip Muysoms, MD, PhD
CONTACT
I
Iris Kyle-Leinhase, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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