Hernia Repair With or Without Sutures (SONS)

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.