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

Institut Catala de Salut

Status

Not yet enrolling

Conditions

Ventral Incisional Hernia

Treatments

Device: Conventional

Device: Glutack

Study type

Interventional

Funder types

Other

Identifiers

NCT06183840

Rafael Villalobos

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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