Clinical trial: A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair (NCT04009213)

Eligibility criteria:
Inclusion Criteria:

        Is male or female, ≥22 years of age

        Is willing and able to give written informed consent

        Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral)

        Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair
        (inguinal or femoral)

        Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the
        following;

          -  3D Max™ Mesh (Bard Inc.)

          -  3D Max™ Light (Bard Inc.)

          -  Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic)

          -  Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic)

        Is willing and able to comply with the protocol assessments at time of surgery and during
        the post surgical follow up period

        Exclusion Criteria:

        Has a hernia type not suitable for laparoscopic hernia repair as determined by the
        Investigator (i.e. strangulated)

        Subject has a recurrent groin hernia previously repaired laparoscopically, has an
        anatomical defect or had prior surgical procedures that in the opinion of the Investigator
        prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair

        Is pregnant or actively breastfeeding

        Has a known sensitivity to cyanoacrylate or formaldehyde,D&C Violet No.2 dye or any
        component of LiquiBand FIX8® or control device

        Has an active or potential infection at the surgical site or systemic sepsis

        Hernia mesh to be used at surgery is less than 4"x6" in size, or not one of the types of
        mesh listed in Inclusion Criteria above

        Cannot tolerate general anaesthesia

        Has any significant or unstable medical or psychiatric condition that, in the opinion of
        the Investigator, would interfere with his/her ability to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.


Patient description (medical language): A 49-year-old man comes to the office because of the bulging in his groin.  Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases.  His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair.

Patient description (patient's own words): I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair.

Does the patient match the trial criteria? 1