When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases.
F Mayer, H Niebuhr, M Lechner...
https://pubmed.ncbi.nlm.nih.gov/26886454Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID02781870
Randomized Study of Laparoscopic Groin Hernia Repair Using 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Glue Fixation
Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
34 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
Researchers are evaluating laparoscopic treatment methods for groin hernias using a special 3D ENDOLAP visible mesh. The study focuses on comparing the safety and effectiveness of mesh placement without fixation versus fixation using LiquiBand Fix 8 glue. This research involves 100 adult patients with primary unilateral inguinal hernias and aims to better understand mesh visualization and potential recurrence over time. Participants will be randomly assigned during surgery to receive the 3D ENDOLAP visible mesh either without any fixation or with mesh fixation using LiquiBand Fix 8 glue. Both groups undergo a standard laparoscopic procedure. The study includes follow-up MRI scans at 1 month and 12 months to visualize the mesh and monitor its position, with additional checks for hernia recurrence up to 60 months. During the trial, patients will have MRI scans to assess the mesh surface and its placement. Researchers will evaluate hernia recurrence at multiple timepoints including 1, 12, 36, and 60 months after surgery. Safety and efficiency of the mesh fixation methods will be closely monitored. The total participation period can extend up to five years to observe long-term outcomes and any potential complications.
CONDITIONS
Brief 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
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
- Contraindications for MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo laparoscopic groin hernia repair using the 3D ENDOLAP visible mesh with or without LiquiBand Fix 8 glue fixation during surgery.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - Up to 60 months
Participants are followed up to assess mesh visualization and recurrence of inguinal hernia.
Visits at 1 month, 12 months, 36 months, and 60 months (in-person)
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
I
Iris Kyle-Leinhase, PhD
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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Published Research Related To This Trial
Innovation in Laparoscopic Inguinal Hernia Reparation - Initial Experiences with the Parietex Progrip Laparoscopic(™) - Mesh.
Pavol Klobusicky, Peter Feyerherd
https://pubmed.ncbi.nlm.nih.gov/26161386