Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.
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.
Fazio
Victor W
VW
Cleveland Clinic, Cleveland, Ohio, USA.
Cohen
Zane
Z
Fleshman
James W
JW
van Goor
Harry
H
Bauer
Joel J
JJ
Wolff
Bruce G
BG
Corman
Marvin
M
Beart
Robert W
RW
Wexner
Steven D
SD
Becker
James M
JM
Monson
John R T
JR
Kaufman
Howard S
HS
Beck
David E
DE
Bailey
H Randolph
HR
Ludwig
Kirk A
KA
Stamos
Michael J
MJ
Darzi
Ara
A
Bleday
Ronald
R
Dorazio
Richard
R
Madoff
Robert D
RD
Smith
Lee E
LE
Gearhart
Susan
S
Lillemoe
Keith
K
Göhl
Jonas
J
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
C118198:Seprafilm; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium