An interventional study of LiquiBand Fix8 glue fixation and No-fixation in Hernia and Recurrence, sponsored by Algemeen Ziekenhuis Maria Middelares. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Diagnostic
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.
Inguinal hernia is a common disease with a high lifetime risk; 27 % for men and 3% for women. These hernias can be categorized as lateral, medial or femoral according to the classification of the European Hernia Society. The manifestations may vary from an asymptomatic swelling till an incarcerated or strangulated hernia requiring an urgent operation.
The introduction of mesh reinforcement for groin hernia repair has resulted in reducing the rate of recurrences and chronic pain. Moreover, laparoscopic repair techniques made it possible to place the mesh in de pre-peritoneal space by a transperitoneal (TAPP) or pre-peritoneal (TEP) approach. These minimally invasive techniques are not only associated with less chronic pain of numbness, but also with an earlier return to normal activities or work. A favor for one of the two techniques has not yet been proven.
Also, the repair of groin hernias always goes along with a discussion about placing the optimal mesh, the optimum mesh size and the optimal fixation method of the mesh. There are a lot of meshes available of different materials, in different sizes and with different properties.
The majority of all meshed need to be fixed to the abdominal wall. Meshes as the anatomic ProGrip Laparoscopic self-fixating mesh (Covidien) has been developed with self-fixating properties due to the polylactic acid micro-grips on one side of the mesh which secures the mesh without requiring any other form of fixation. While the ENDOLAP 3D visible mesh (Dynamesh) has been developed with a pre-shaped form that fits the defect naturally and therefore makes a fixation redundant.
However, no consensus on the best method of mesh fixation or even non-fixation can be found in the common literature. Penetrating fixation methods of the mesh have a strong positioning as result, but for inguinal hernia, mesh fixation using titanium tacks with or without sutures clearly indicated more development of postoperative pain and discomfort for the patient. Current recommendations are to avoid penetrating fixation and replace this by either no fixation or fixation with glue. This will decrease pain but should not risk a less stable mesh fixation ongoing with recurrence due to mesh shifting of mesh shrinkage. It is known that the majority of implanted meshes shrink to an extent, which might be of disadvantage for the patient. This has already been demonstrated in several animal studies, but clinical information on the mesh shrinkage is rare and mostly a result from revisional surgery.
LiquiBand Fix 8 glue is a new, innovative hernia mesh fixation device providing strong and secure mesh fixation without causing any tissue damage or mechanical trauma. LiquiBand Fix 8 received CE mark approval in May 2014.
All ordinary meshes for groin hernia repair, based on polymeric textile, are invisible to conventional imaging techniques, inclusive "magnetic resonance imaging" (MRI). The ENDOLAP 3D mesh visible (Dynamesh), developed by a unique method, contains an amount of iron particles, woven in the ordinary structure of the mesh, which allows an imaging in the MRI.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation.
Procedure: No-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.
Procedure: LiquiBand Fix8 glue fixation
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
Also known as: LiquiBand Fix8 glue
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.
visualization of mesh surface
Visualization of the mesh surface at 12 months postoperative observed with MRI scan rate after laparoscopic repair of unilateral inguinal hernias using the 3D-Endolap visible mesh with or without LiquiBand® Fix 8™ glue fixation.
Time frame: 12 months
visualization of mesh surface
Visualization of the mesh surface at 1 month postoperative observed with MRI scan
Time frame: 1 month
recurrence of inguinal hernia
Recurrence rate of inguinal hernia measured at 1 month, 12, 36 and 60 months clinically of by ultrasound as indicated.
Time frame: 1 month, 12 months, 36 months and 60 months
Quality of Life assessment
Quality of Life assessment with the EuraHS QoL
Time frame: 1 month, 12 months, 36 months and 60 months
Plan to share: No
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Algemeen Ziekenhuis Maria Middelares