Clinical trial NCT02781870: Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation
Official title: Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia
Recurrence
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
Collaborators: name: Duomed
First posted: 2016-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

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.

Primary outcomes:
measure: visualization of mesh surface
timeFrame: 12 months
Secondary outcomes:
measure: visualization of mesh surface
timeFrame: 1 month
measure: recurrence of inguinal hernia
timeFrame: 1 month, 12 months, 36 months and 60 months
Other outcomes:
measure: Quality of Life assessment
timeFrame: 1 month, 12 months, 36 months and 60 months
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Filip Muysoms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Klobusicky 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.