Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair

Study Overview
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Brief Summary
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This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

Detailed Description
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Patients older than 18 years undergoing an elective ventral/incisional hernia laparoscopic repair with a hernia defect between 4-10cm of transversal defect The patients included are adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3) For the interventional procedure, three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm (125 per arm): either traumatic fixation with the conventional procedure and device or with Glutack-Glubran®2. After two years of follow-up, the recurrence will be analyzed.

Official Title
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OMEGA Trial: A Multicenter Randomized Controlled Non-inferiority Trial of Only MEsh Fixation With a Glue Applicator Comparing Traumatic vs Atraumatic Fixation of the Mesh in Ventral/Incisional Laparoscopic Repair

Conditions
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Ventral Incisional Hernia

Intervention / Treatment
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* Device: Glutack
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3) ASA grade from I-II Informed consent signed Exclusion Criteria: Patients less than 18 years and over 80 years of age. Fascial transverse defect less than 4 cm and more than 8 cm. Recurrent ventral or incisional hernia in the same place Emergency surgery Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery) BMI greater than 35 Kg/m2 ASA III-IV Pregnancy Tobacco

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Patients with a traumatic fixation of the mesh | Device: Conventional<br>* Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Traumatic fixation<br>* Other names: Traumatic fixation;|
| Experimental: Glutack<br>Patient with Glutack mesh fixation | Device: Glutack<br>* Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Glutack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique. | The fixation of the mesh with atraumatic material with glue is as good as the conventional traumatic fixation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative pain between atraumatic and traumatic fixation of the mesh (EuraHS Quality of life scale: 0-10). Ten is the worst outcome |  | 2 years | 
| Types of comorbidities related on the surgery as visceral adhesions, seroma, hematoma, bulging, port site incisional hernia, recurrence |  | 2 years | 
| Quality of life (QoL) between the two types of fixations with the EuraHS scale at 1 month, 6 months, 12 months, and 24 months. EurasHS scale of 10 is the worst outcome |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventral hernia, Incisional hernia, Mesh, Glue, Tackers, IPOM plus