Clinical trial: A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair (NCT02240550)

Eligibility criteria:
Inclusion Criteria:

          -  Scheduled to undergo routine inguinal hernia repair

          -  Male and Female patients between 18 and 65 years old

          -  Competent to give consent

          -  Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)

          -  Defect size at operation is between 5mm and 35mm

          -  Diagnosed with unilateral, direct, indirect or mixed inguinal hernia

          -  Primary hernia at the operative site

        Exclusion Criteria:

          -  Signs of obvious local or systemic infection

          -  Any previous surgery on the hernia operative site

          -  Hernia is not in the inguinal area

          -  Hernia is not identified as indirect or direct

          -  Femoral hernias

          -  Known collagen disorder

          -  Presenting with unstable angina or NYHA class of IV

          -  Known Pregnancy or Nursing women

          -  Active drug user

          -  Recurrence of a repair by any method

          -  Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter
             - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3

          -  Immunosuppression, prednisone>15 mg/day, active chemotherapy

          -  End stage renal disease

          -  Abdominal ascites

          -  Skin infection in area of surgical field

          -  BMI >35

          -  Peritoneum cannot be closed

          -  Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to
             cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency
             syndrome of any type)

          -  Neutropenia with absolute neutrophil count (ANC)<500 cells/mm3

          -  Significant of life-threatening condition (e.g., endocarditis) that would confound or
             interfere with the procedure

          -  Patients that require anticoagulant monitoring with an activated partial
             thromboplastin time (aPTT)

          -  Patients unwilling to forego blood and/or blood product donation for at least 3 months
             from initiation of first study device

          -  Treatment with investigational medicinal product within 30 days before enrollment and
             for the duration of the study

          -  Investigational device present, or removed within 30 days before enrollment, or
             presence of device-related infection

          -  Patients who the investigator considers unlikely to adhere to the protocol or complete
             the clinical study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

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