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NCT Number: NCT06183840

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

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.

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Key information

Conditions

Ventral Incisional Hernia Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutack

Device

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

Conventional

Device

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

Other names: Traumatic fixation

Primary outcomes

  1. Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

    Time frame: 2 years

    The fixation of the mesh with atraumatic material with glue is as good as the conventional traumatic fixation

Secondary outcomes

  1. Rate of postoperative pain between atraumatic and traumatic fixation of the mesh (EuraHS Quality of life scale: 0-10). Ten is the worst outcome

    Time frame: 2 years

  2. Types of comorbidities related on the surgery as visceral adhesions, seroma, hematoma, bulging, port site incisional hernia, recurrence

    Time frame: 2 years

  3. 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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Institut Catala de Salut

Other Gov

Registry information

Official study title

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

Acronym: OMEGA

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 28, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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