title: A belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair.
abstract: BACKGROUND
  A variety of anti-adhesive composite mesh products have become available to use inside the peritoneal cavity. However, reimbursement of these meshes by the Belgian Governemental Health Agency (RIZIV/INAMI) can only be obtained after conducting a prospective study with at least one year of clinical follow-up. This -Belgian multicentric cohort study evaluated the experience with the use of Proceed®-mesh in laparoscopic ventral hernia repair.
  
  
  METHODS
  During a 25 month period 210 adult patients underwent a laparoscopic primary or incisional hernia repair using an intra-abdominal placement of Proceed®-mesh. According to RIZIV/INAMI criteria recurrence rate after 1 year was the primary objective, while postoperative morbidity, including seroma formation, wound and mesh infections, quality of life and recurrences after 2 years were evaluated as secondary endpoints (NCT00572962).
  
  
  RESULTS
  In total 97 primary ventral and 103 incisional hernias were repaired, of which 28 (13%) were recurrent. There were no conversions to open repair, no enterotomies, no mesh infections and no mortality. One year cumulative follow-up showed 10 recurrences (n = 192, 5.2%) and chronic discomfort or pain in 4.7% of the patients. Quality of life could not be analyzed due to incomplete data set.
  
  
  CONCLUSIONS
  More than 5 years after introduction of this mesh to the market, this prospective multicentric study documents a favorable experience with the Proceed mesh in laparoscopic ventral hernia repair. However, it remains to be discussed whether reimbursement of these meshes in Belgium should be limited to the current strict criteria and therefore can only be obtained after at least 3-4 years of clinical data gathering and necessary follow-up.
authors.affiliation: University Hospital Ghent, Ghent, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Berrevoet
authors.forename: T
authors.initials: T
authors.lastname: Tollens
authors.forename: L
authors.initials: L
authors.lastname: Berwouts
authors.forename: C
authors.initials: C
authors.lastname: Bertrand
authors.forename: F
authors.initials: F
authors.lastname: Muysoms
authors.forename: J
authors.initials: J
authors.lastname: De Gols
authors.forename: E
authors.initials: E
authors.lastname: Meir
authors.forename: A
authors.initials: A
authors.lastname: De Backer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006555:Hernia, Ventral / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D006801:Humans; D015994:Incidence; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D013526:Surgical Mesh / Q000592:standards / Q000706:statistics & numerical data*; D016896:Treatment Outcome