Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• adult patients presenting with primary unilateral inguinal hernia

• patients planed for a laparoscopic repair

Locations
Other Locations
Belgium
AZ Maria Middelares
RECRUITING
Ghent
Contact Information
Primary
Filip Muysoms, MD, PhD
filip.muysoms@azmmsj.be
0032-92467400
Backup
Iris Kyle-Leinhase, PhD
iris.kyle-leinhase@azmmsj.be
+3292467451
Time Frame
Start Date: 2016-05-09
Estimated Completion Date: 2027-08
Participants
Target number of participants: 100
Treatments
Other: No-fixation
These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation.
Experimental: LiquiBand Fix glue fixation
These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.~Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
Related Therapeutic Areas
Sponsors
Collaborators: Duomed
Leads: Algemeen Ziekenhuis Maria Middelares

This content was sourced from clinicaltrials.gov