Laparoscopic repair of groin hernias using a special visible mesh
Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation
NA · Algemeen Ziekenhuis Maria Middelares · NCT02781870
This study is testing a new type of visible mesh for fixing groin hernias to see if it works better and is safer than using glue for the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Algemeen Ziekenhuis Maria Middelares (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT02781870 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a 3D ENDOLAP visible mesh for laparoscopic groin hernia repair, comparing it with a fixation method using LiquiBand Fix 8 glue. A total of 100 patients will undergo the procedure, with follow-up MRI scans at 1 and 12 months post-operation to visualize the mesh in vivo. The study aims to determine the optimal fixation technique and assess the outcomes related to hernia recurrence and chronic pain. Four surgeons will screen eligible patients over a 24-month inclusion period.
Who should consider this trial
Good fit: Ideal candidates include adult patients with primary unilateral inguinal hernias who are scheduled for laparoscopic repair.
Not a fit: Patients with recurrent or incarcerated hernias, those requiring open repair, or individuals with contraindications for MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients undergoing groin hernia repair.
How similar studies have performed: While there have been studies on various mesh types and fixation methods, the specific use of the ENDOLAP 3D visible mesh in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients presenting with primary unilateral inguinal hernia * patients planed for a laparoscopic repair Exclusion Criteria: * 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 this trial is running
Ghent
- AZ Maria Middelares — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Filip Muysoms, MD, PhD — Algemeen Ziekenhuis Maria Middelares
- Study coordinator: Filip Muysoms, MD, PhD
- Email: filip.muysoms@azmmsj.be
- Phone: 0032-92467400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hernia, Recurrence