Abstract:

Primary ventral and even small incisional hernias have historically been repaired by primary closure; however, data proves that use of mesh can significantly reduce hernia recurrence. Here we report clinical outcomes at one year using the International Hernia Mesh Registry following the use of a three-dimensional tissue-separating mesh device (Proceed Ventral Patch™, Ethicon, Somerville, NJ). This ongoing prospective multi-center registry collects preoperative, perioperative, and postoperative outcome data including adverse events at 1, 6, 12, and 24 months. Patient-reported outcomes are collected including a hernia-specific questionnaire. A total of 234 patients (72.1% male, 27.9% female) from 13 sites in the United States and Europe were enrolled. Mean age and BMI were 52.2 (SD 15.0) and 29.2 kg/m2 (SD 5.2), respectively. Hernia types: umbilical 67.1%, epigastric 11.5%, small incisional including trocar 21.3%. Preoperatively 46.9% and 38.3% of patients reported symptomatic pain and movement scores, respectively. At 1 year, these were significantly reduced to 8.9% and 5.0%, respectively (p < 0.001). At 12 months hernia recurrence was 3.0% (95% CI, 1.2% to 6.1%), seroma (2.1%), infection (2.1%) with other events being less than 1%. These results indicate repair using this device led to significant improvement in pain and movement limitations and were associated with low complication and recurrence rates.

Authors:

Tim Tollens, MD , Consultant , Department of General Surgery, Imelda Hospital, Bonheiden, Belgium, Jenny Mitchell, BA, Manager, Ethicon Clinical Development, Livingston, United Kingdom, Peter Jones, MS, Statistician, Clinical Development, Ethicon Surgical Care, Livingston, United Kingdom, Frederik Berrevoet, MD, PhD, Associate Professor of Surgery, Department of General and Hepatobiliary Surgery, Liver Transplantation Service , University Hospital Ghent, Ghent, Belgium

PMID:  24574019

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