HerniaNCT02781870
Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
A study testing LiquiBand Fix8 glue fixation and No-fixation in people with Hernia and Recurrence, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Recurrence
- What is being tested?
- LiquiBand Fix8 glue fixation and No-fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2016to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients presenting with primary unilateral inguinal hernia
- patients planed for a laparoscopic repair
Who cannot join
- 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
Show all 9Show fewer
- pregnant women
- ASA score 4 or more
- contra-indications for MRI scans.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, 9000
Iris Kyle-Leinhase, PhD, 92467451, iris.kyle-leinhase@azmmsj.be
Filip Muysoms, MD, PhD
About this study
Official title: Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation
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.
Read the detailed description
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.
- Conditions
- Hernia, Recurrence
- Being tested
- LiquiBand Fix8 glue fixation, No-fixation
- Medical subject headings
- Hernia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBand Fix8 glue fixationProcedure or surgery
Also called LiquiBand Fix8 glue
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
No-fixationProcedure or surgery
Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.
| Study group | Role | What they receive |
|---|---|---|
| No-fixation | Other | These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation. Receives: Procedure: No-fixation |
| LiquiBand Fix glue fixation | Experimental | 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. Receives: Procedure: LiquiBand Fix8 glue fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
visualization of mesh surface
Visualization of the mesh surface at 1 month postoperative observed with MRI scan
Measured: 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.
Measured: 1 month, 12 months, 36 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start9 May 2016
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Collaborators
- Duomed
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Filip Muysoms, MD, PhD, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781870
- Sponsor's protocol ID
- EUGENE STUDY
- Status last verified
- Apr 2025
- First submitted
- 10 May 2016
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.
PubMed 26886454Klobusicky P, Feyerherd P. Innovation in Laparoscopic Inguinal Hernia Reparation - Initial Experiences with the Parietex Progrip Laparoscopic() - Mesh. Front Surg. 2015 Jun 25;2:28. doi: 10.3389/fsurg.2015.00028. eCollection 2015.
PubMed 26161386
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation
- ClinicalTrials.gov ID
- NCT02781870
- Acronym / sponsor ID
- EUGENE STUDY
- Conditions
- Hernia, Recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Collaborators
- Duomed
- Study start
- 9 May 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-fixation | Other | Procedure: No-fixationThese patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation. |
| LiquiBand Fix glue fixation | Experimental | Procedure: LiquiBand Fix8 glue fixationThese 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients presenting with primary unilateral inguinal hernia
- patients planed for a laparoscopic repair
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiquiBand Fix8 glue fixationAlso: LiquiBand Fix8 gluePatients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation. | Procedure or surgery | LiquiBand Fix glue fixation |
| No-fixationPatients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation. | Procedure or surgery | No-fixation |
Primary outcome
visualization of mesh surface
Time frame: 12 months
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.
2 secondary outcomes
visualization of mesh surface
Time frame: 1 month
recurrence of inguinal hernia
Time frame: 1 month, 12 months, 36 months and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 26886454Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.
- Background: PubMed 26161386Klobusicky P, Feyerherd P. Innovation in Laparoscopic Inguinal Hernia Reparation - Initial Experiences with the Parietex Progrip Laparoscopic() - Mesh. Front Surg. 2015 Jun 25;2:28. doi: 10.3389/fsurg.2015.00028. eCollection 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filip Muysoms, MD, PhD principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBand Fix8 glue fixation and No-fixation in people with Hernia and Recurrence, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Muysoms, MD, PhD (0032-92467400 ext. FC, filip.muysoms@azmmsj.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visualization of mesh surface (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781870, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.