Ventral Incisional Hernia
Conditions
Keywords
Ventral hernia, Incisional hernia, Mesh, Glue, Tackers, IPOM plus
Brief summary
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
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.
Interventions
DEVICEGlutack
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
DEVICEConventional
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
Sponsors
Institut Catala de Salut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique. | 2 years | The fixation of the mesh with atraumatic material with glue is as good as the conventional traumatic fixation |
Secondary
| Measure | 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 |
Outcome results
None listed