Hernia Repair With or Without Sutures

This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.

Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.

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.