title: Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: Victor W
authors.initials: VW
authors.lastname: Fazio
authors.forename: Zane
authors.initials: Z
authors.lastname: Cohen
authors.forename: James W
authors.initials: JW
authors.lastname: Fleshman
authors.forename: Harry
authors.initials: H
authors.lastname: van Goor
authors.forename: Joel J
authors.initials: JJ
authors.lastname: Bauer
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Wolff
authors.forename: Marvin
authors.initials: M
authors.lastname: Corman
authors.forename: Robert W
authors.initials: RW
authors.lastname: Beart
authors.forename: Steven D
authors.initials: SD
authors.lastname: Wexner
authors.forename: James M
authors.initials: JM
authors.lastname: Becker
authors.forename: John R T
authors.initials: JR
authors.lastname: Monson
authors.forename: Howard S
authors.initials: HS
authors.lastname: Kaufman
authors.forename: David E
authors.initials: DE
authors.lastname: Beck
authors.forename: H Randolph
authors.initials: HR
authors.lastname: Bailey
authors.forename: Kirk A
authors.initials: KA
authors.lastname: Ludwig
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Stamos
authors.forename: Ara
authors.initials: A
authors.lastname: Darzi
authors.forename: Ronald
authors.initials: R
authors.lastname: Bleday
authors.forename: Richard
authors.initials: R
authors.lastname: Dorazio
authors.forename: Robert D
authors.initials: RD
authors.lastname: Madoff
authors.forename: Lee E
authors.initials: LE
authors.lastname: Smith
authors.forename: Susan
authors.initials: S
authors.lastname: Gearhart
authors.forename: Keith
authors.initials: K
authors.lastname: Lillemoe
authors.forename: Jonas
authors.initials: J
authors.lastname: Göhl
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002266:Carboxymethylcellulose Sodium / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D007391:International Cooperation; D007415:Intestinal Obstruction / Q000517:prevention & control*; D007421:Intestine, Small; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D013997:Time Factors; D000267:Tissue Adhesions / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: C118198:Seprafilm; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium