Sodium hyaluronate-based bioresorbable membrane (Seprafilm((R))) reduced early postoperative intestinal obstruction after lower abdominal surgery for colorectal cancer: the preliminary report.

摘要

PURPOSES: This study is a prospective randomized clinical trial to evaluate the clinical safety and the effect of a sodium hyaluronate-based bioresorbable membrane (Seprafilm(R); Genzyme, Cambridge, MA, USA) for reducing adhesive intestinal obstruction after colorectal cancer surgery. MATERIALS AND METHODS: Between November 2002 and December 2003, 504 patients underwent radical resection for sigmoid or rectal cancer. Among these patients, 427 patients were enrolled in this study. The patients were randomized into the Seprafilm(R) group (N = 185) and the control group (N = 242). All the patients in the Seprafilm(R) group received one sheet of Seprafilm(R) over the pelvic inlet where the peritoneum was denuded due to pelvic dissection. Intestinal obstruction was defined when there were symptoms of nausea, vomiting, and abdominal distension combined with an obstructive bowel pattern on the radiologic evaluation. RESULTS: The median follow-up period was 25.0 months. There were no significant differences between the Seprafilm(R) and the control groups for the clinicopathologic parameters. There were no differences in the incidence of complications between the two groups; however, the incidence of early postoperative intestinal obstruction was significantly less in the Seprafilm(R) group than in the control group (2.7% vs 7.0%, respectively, p = 0.045). Five patients in the Seprafilm(R) group experienced postoperative intestinal obstruction (2.7%) compared with 11 patients in the control group (4.6%) during the follow-up period; however, there was no statistical difference. CONCLUSIONS: Seprafilm(R) appears to be effective in preventing early postoperative intestinal obstruction and there was a trend for reduced intestinal obstruction after lower abdominal surgery for colorectal cancer.