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

PURPOSE: The aim of the study was to assess the impact of sodium hyaluronat e and carboxymethylcellulose membrane (Seprafilm(R)) on postoperative intes tinal obstruction as judged br the rates of bowel obstruction and laparotom y for bowel obstruction. A secondary aim was to assess early postoperative morbidity. METHODS: All patients mho had Seprafilm(R) placed during colorec tal surgery between June 1993 and October 1998 were included in the study g roup and compared with a matched group of patients without Seprafilm(R). Al l patients were assessed for intestinal obstruction and complications by te lephone interview and chart review. Statistical tests for independence were used where appropriate; alpha was 0.05 for all tests, and the two groups w ere tested for case matching. Fisher's exact test was used to compare gende r distribution, nature of diagnosis (inflammatory vs. noninflammatory), and urgency of surgery (elective vs. emergency). The age distribution, number of prior abdominal surgeries, and operative time were compared by Student's t-test. Approximation of Katz test was used for independent proportions to compare the two groups for early postoperative morbidity and overall incid ence of intestinal obstruction and surgical enterolysis. The incidence of i ntestinal obstruction between the two groups was also compared with Kaplan- Meier product limit method and log-rank test. RESULTS: Two hundred fifty-ni ne patients in whom Seprafilm(R) was placed were compared with a well-match ed control cohort of 179 patients. The two groups did not differ in gender or age. One-half of each group had inflammatory conditions, and approximate ly 90 percent of each group underwent elective operations, The operative ti mes mere 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(R) group and 15.6 percent for the controls, with mortality rates of 0.8 percent and 0.0 percent, respectively. There a ere 12 intestinal obstructions in 12 patients in the Seprafilm(R) group and 12 intestinal obstructions in 11 patients in the control group at a follow-up period of 65 months in the Seprafilm(R) group and 81 months in the control group. Eight of the 12 intestinal obstructions in the Seprafilm(R) group re solved with conservative management while only 5 of 12 in the control group responded without surgery. Thus the enterolysis rate was 1.5 percent in th e Seprafilm(R) group and 3.9 percent in the control group, demonstrating a trend in favor of Seprafilm(R). There were no statistically significant dif ferences in the incidence of either overall or abdominopelvic septic compli cations between the Seprafilm(R) (3.4 percent) and control (1.1 percent) gr oups. CONCLUSION: During short-term follow-up in this nonprospective, nonra ndomized study, limited placement of Seprafilm(R) did not significantly red uce the need for surgical enterolysis for intestinal obstruction or signifi cantly adversely affect the morbidity rate. However, a long-term, prospecti ve, randomized trial is underway to elucidate these issues.