title: A prospective study of one-year clinical outcomes utilizing a composite three-dimensional device with a tissue-separating layer for repair of primary ventral and small incisional hernia.
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.affiliation: Department of General Surgery Imelda Hospital Bonheiden, Belgium.
authors.forename: Tim
authors.initials: T
authors.lastname: Tollens
authors.affiliation: Ethicon Clinical Development Livingston, United Kingdom.
authors.forename: Jenny
authors.initials: J
authors.lastname: Mitchell
authors.affiliation: Ethicon Surgical Care Livingston, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Jones
authors.affiliation: Department of General and Hepatobiliary Surgery Liver Transplantation Service University Hospital Ghent Ghent, Belgium.
authors.forename: Frederik
authors.initials: F
authors.lastname: Berrevoet
mesh_terms: D000328:Adult; D000368:Aged; D005060:Europe; D005260:Female; D059685:Herniorrhaphy / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D000069290:Incisional Hernia / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States