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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitut Catala de Salut

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Glutack
  • Conventional

Treatment groups

250 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators