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

Launched by INSTITUT CATALA DE SALUT · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to fix hernias, which are bulges that can happen in the abdomen after surgery. Specifically, the trial is comparing two methods of attaching a special mesh (a type of material used to support the area where the hernia is) during laparoscopic surgery, which is a minimally invasive technique. One method uses a glue called GLUTACK-Glubran2®, while the other uses traditional mechanical staples. The main goal is to see if the glue method is just as good as the traditional method in preventing hernias from coming back within two years after surgery.

To participate in this trial, adults aged 18 to 80 who have a specific size hernia (between 4 to 8 cm) and a body mass index (BMI) under 35 are eligible. Participants will need to sign a consent form agreeing to take part in the study. If someone joins the trial, they can expect to undergo the laparoscopic hernia repair using one of the two methods being studied. It’s important to know that this trial is not yet recruiting participants, so there will be some time before anyone can sign up.

Gender

ALL

Eligibility criteria

• 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