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Reduction in Adhesive Small-Bowel Obstruction by Seprafilm® Adhesion Barrier After Intestinal Resection

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Diseases of the Colon & Rectum


Although Seprafilm® has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction.


This was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm® or no treatment. Seprafilm® was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years.


There was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm® patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm® was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up.


The overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm®, which was the only factor that predicted this outcome.

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The authors thank the many study coordinators and monitors who participated in this study, Beverly Accomando, M.S., the study statistician, and Keith Kelly, M.D., and Jacques Heppell, M.D., Mayo Clinic, Scottsdale, Arizona, who contributed patients to and assisted with the study.

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Correspondence to David E. Beck M.D..

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Supported by a grant from Genzyme Corporation, which manufacturers Seprafilm.

Read at the meeting of The American Society of Colon and Rectal Surgeons, Dallas, Texas, May 10 to 13, 2004.



Seprafim® Medical Advisory Steering Committee

David E. Beck, M.D., Zane Cohen, M.D., James W. Fleshman, M.D., Howard S. Kaufman, M.D., Harry van Goor, M.D., Bruce G. Wolff, M.D.

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Fazio, V.W., Cohen, Z., Fleshman, J.W. et al. Reduction in Adhesive Small-Bowel Obstruction by Seprafilm® Adhesion Barrier After Intestinal Resection. Dis Colon Rectum 49, 1–11 (2006).

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