PREVENTION OF POSTOPERATIVE - ABDOMINAL ADHESIONS BY A SODIUM HYALURONATE-BASED BIORESORBABLE MEMBRANE - A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTER STUDY

BACKGROUND: Postoperative abdominal adhesions are associated with nume rous complications, including small bowel obstruction, difficult and d angerous reoperations, and infertility. A sodium hyaluronate and carbo xymethylcellulose bioresorbable membrane (HA membrane) was developed t o reduce formation of postoperative adhesions. The objectives of our p rospective study were to assess the incidence of adhesions that recurr ed after a standardized major abdominal operation using direct laparos copic peritoneal imaging and to determine the safety and effectiveness of HA membrane in preventing postoperative adhesions. STUDY DESIGN: E leven centers enrolled 183 patients with ulcerative colitis or familia l polyposis who were scheduled for colectomy and deal pouch-anal anast omosis with diverting-loop ileostomy. Before abdominal closure, patien ts were randomly assigned to receive or not receive HA membrane placed under the midline incision. At ileostomy closure eight to 12 weeks la ter, laparoscopy was used to evaluate the incidence, extent, and sever ity of adhesion formation to the midline incision. RESULTS: Data were analyzed for 175 assessable patients. While only five (6 percent) of 9 0 control patients had no adhesions, 43 (51 percent) of 85 patients re ceiving HA membrane were free of adhesions (p<0.00000000001). The mean percent of the incision length involved was 63 percent in the control group, significantly greater than the 23 percent observed in patients who received HA membrane (p<0.001). Dense adhesions were observed in 52 (58 percent) of the 90 control patients, but in only 13 (15 percent ) of the 85 receiving HA membrane (p<0.0001). Comparison of the incide nce of specific adverse events between the groups did not identify a d ifference (p>0.05). CONCLUSIONS: This study represents the first contr olled, prospective evaluation of postoperative abdominal adhesion form ation and prevention after general abdominal surgery using standardize d, direct peritoneal visualization. In this study HA membrane was safe and significantly reduced the incidence, extent, and severity of post operative abdominal adhesions.