NCT02781870 Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
| NCT ID | NCT02781870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Algemeen Ziekenhuis Maria Middelares |
| Condition | Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2016-05-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2016-05-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Filip Muysoms, MD, PhD
PRINCIPAL INVESTIGATOR
Algemeen Ziekenhuis Maria Middelares
Frequently Asked Questions
Who can join the NCT02781870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02781870 currently recruiting?
Yes, NCT02781870 is actively recruiting participants. Contact the research team at filip.muysoms@azmmsj.be for enrollment information.
Where is the NCT02781870 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT02781870 clinical trial?
NCT02781870 is sponsored by Algemeen Ziekenhuis Maria Middelares. The principal investigator is Filip Muysoms, MD, PhD at Algemeen Ziekenhuis Maria Middelares. The trial plans to enroll 100 participants.