Clinical trial: Hernia Repair With or Without Sutures (NCT00905320)

Eligibility criteria:
Inclusion Criteria:

        Demographics:

          -  Age ≥ 18 years old

          -  If female, negative pregnancy test

        Pre-Operative Findings:

          -  Presence of an abdominal hernia associated with previous surgical incision

          -  Midline ventral\incisional hernia demonstrated either on physical examination by
             investigators or radiologic imaging tests.

          -  CT scan, MRI, Ultrasound

          -  No evidence of incarceration, strangulation

          -  Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)

          -  Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter

        Exclusion Criteria:

        Pre-Operative History:

          -  Severe medical co-morbidities that prevent safe performance of laparoscopic surgery
             including coronary artery disease, obstructive pulmonary disease, etc.

          -  History of the following:

               -  Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)

               -  Chronic use (defined as greater than 3 months) of narcotic analgesic for pain
                  other than from the hernia that is intended to be repaired

          -  Allergy to products used in hernia repair including surgical mesh

          -  Any abdominal ventral incisional hernia previously repaired with permanent synthetic
             mesh placed inside the peritoneal cavity

          -  Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of
             the abdominal musculature and fascia)

          -  Presence of simultaneous intra-abdominal infection

          -  Simultaneous presence of a bowel obstruction

          -  History of suspected or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          -  Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the Investigator, may interfere with study assessments or compliance.

        Intra-operative Findings:

          -  Simultaneous performance of another surgical procedure during hernia repair other than
             acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)

          -  Intra-operative identification of full thickness injury to intestine (i.e.
             enterotomy), liver, bladder, etc.
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.


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? Entailment