Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT02781870

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients presenting with primary unilateral inguinal hernia
  • Patients planned for laparoscopic repair
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

AZ Maria Middelares

Ghent, Belgium, 9000

Actively Recruiting

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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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