Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm®) have possible short-term beneficial impact?

Abstract

PURPOSE: The aim of the study was to assess the impact of sodium hyaluronate and carboxymethylcellulose membrane (Seprafilm®) on postoperative intestinal obstruction as judged by the rates of bowel obstruction and laparotomy for bowel obstruction. A secondary aim was to assess early postoperative morbidity. METHODS: All patients who had Seprafilm® placed during colorectal surgery between June 1993 and October 1998 were included in the study group and compared with a matched group of patients without Seprafilm®. All patients were assessed for intestinal obstruction and complications by telephone interview and chart review. Statistical tests for independence were used where appropriate; alpha was 0.05 for all tests, and the two groups were tested for case matching. Fisher's exact test was used to compare gender distribution, nature of diagnosis (inflammatoryvs. noninflammatory), and urgency of surgery (electivevs. emergency). The age distribution, number of prior abdominal surgeries, and operative time were compared by Student'st-test. Approximation of Katz test was used for independent proportions to compare the two groups for early postoperative morbidity and overall incidence of intestinal obstruction and surgical enterolysis. The incidence of intestinal obstruction between the two groups was also compared with Kaplan-Meier product limit method and log-rank test. RESULTS: Two hundred fifty-nine patients in whom Seprafilm® was placed were compared with a well-matched control cohort of 179 patients. The two groups did not differ in gender or age. One-half of each group had inflammatory conditions, and approximately 90 percent of each group underwent elective operations. The operative times were similar. Both groups had a similar number of abdominal operations before inclusion (mean = 1.2, both groups). Early morbidity rates were 17.8 percent for the Seprafilm® group and 15.6 percent for the controls, with mortality rates of 0.8 percent and 0.0 percent, respectively. There were 12 intestinal obstructions in 12 patients in the Seprafilm® group and 12 intestinal obstructions in 11 patients in the control group at a follow-up period of 65 months in the Seprafilm® group and 81 months in the control group. Eight of the 12 intestinal obstructions in the Seprafilm® group resolved with conservative management while only 5 of 12 in the control group responded without surgery. Thus the enterolysis rate was 1.5 percent in the Seprafilm® group and 3.9 percent in the control group, demonstrating a trend in favor of Seprafilm®. There were no statistically significant differences in the incidence of either overall or abdominopelvic septic complications between the Seprafilm® (3.4 percent) and control (1.1 percent) groups. CONCLUSION: During short-term follow-up in this nonprospective, nonrandomized study, limited placement of Seprafilm® did not significantly reduce the need for surgical enterolysis for intestinal obstruction or significantly adversely affect the morbidity rate. However, a long-term, prospective, randomized trial is underway to elucidate these issues.