• The primary endpoint is the rate of hernia recurrence in study subjects. A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure. [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]
  

• Perioperative complications will be assessed by evaluation of the procedural and device related adverse events (AEs) collected from the time surgery is initiated until the day the patient is discharged from the hospital. [ Time Frame: From the time of surgery to hospital discharge. ] [ Designated as safety issue: Yes ]
  
• Short-term complications will be assessed by evaluation of the procedural and device related AEs collected from the day after the patient is discharged from the hospital until 21 days post procedure. [ Time Frame: 21 days post surgery ] [ Designated as safety issue: Yes ]
  
• Long-term complications will be assessed by evaluation of the procedural and device related AEs collected after 21 days up to 1 year. [ Time Frame: 1 year post surgery ] [ Designated as safety issue: Yes ]
  
• Changes in QOL will be assessed from baseline to 1 year utilizing the Carolinas Comfort Scale survey. [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]
  
• Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed. [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  

More than 2 million abdominal operations occur annually in the United States, with up to 20% of those patients developing a ventral incisional hernia. This translates into 90,000 ventral incisional hernia repairs which are performed on a yearly basis. There are two basic types of incisional hernia repair: sutured (primary) repair or mesh repair. Mesh repairs procedures, both open or laparoscopic, have been reported to lead to fewer recurrences and overall low complication rates compared to primary repairs. A randomized trial comparing suture repairs to mesh repairs published in 2003 reported 3-year cumulative recurrence rates (suture vs. mesh) of 43% v. 24% for primary hernias and 58% v. 20% for recurrent hernias. A retrospective review of 77 patients who underwent elective repair of midline incisional hernias revealed a 3-year recurrence rate of 54% in patients who underwent primary repair v. 29% for those undergoing mesh repairs. Recurrence rates were not increased in patients with diabetes or cardiopulmonary disease; however, recurrence did appear more likely in obese patients. It is thought that the lower recurrence rates reported after mesh repairs may be the result of lower tension on abdominal wall tissues compared to primary repairs.

A recent publication6 reported on the results of open ventral hernia repair (OVHR) using a two-sided mesh in 455 patients. The overall complication rate was low [40/455, 8.8%] with hernia recurrence seen in only 1%. This study will collect data on patients undergoing OVHR using a similar mesh product, the Bard Ventrio Hernia Patch.