Safety and long-term outcome of a new concept for surgical adhesion-reduction strategies (Prevadh): a prospective, multicenter study.
Abstract
BACKGROUND/AIMS: No agent has been consistently effective in preventing formation of peritoneal adhesions and postoperative bowel obstruction after abdominal surgery. The aim of this prospective multicenter study was to assess clinical safety and efficiency of a new adhesion-reduction barrier METHODOLOGY: Between September 2000 and April 2001, Prevadh was used in 78 patients. Operative procedures included 25 hepatic resections, 7 cholecystectomies, 32 colonic resections, 7 protectomies, 3 colostomy or recovery of continuity, 1 gynaecologic surgery and 3 others. Eleven patients were operated on by laparoscopy and 67 by laparotomy. RESULTS: The overall incidence of abscesses and wound complications was 2.4% and 9% respectively. After a mean follow-up of 36 months (range: 4-51 months), no patients experienced adverse events related to the adhesion barrier. Surgical reoperative procedures were performed in 10 patients for unrelated causes and no bowel obstruction occurred within the protected area. CONCLUSIONS: This study confirmed the safety of Prevadh adhesion barrier and suggested that this resorbable barrier might provide prevention from adhesion formation on peritoneal injured surfaces. However, a large randomized controlled trial remains necessary to prove the real effectiveness of adhesion barriers on clinical long-term outcome.