Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection

Victor W. Fazio; Zane Cohen; James W. Fleshman; Harry Van Goor; Joel J. Bauer; Bruce G. Wolff; Marvin Corman; Robert W. Beart; Steven D. Wexner; James M. Becker; John R.T. Monson; Howard S. Kaufman; David E. Beck; H. Randolph Bailey; Kirk A. Ludwig; Michael J. Stamos; Ara Darzi; Ronald Bleday; Richard Dorazio; Robert D. Madoff; Lee E. Smith; Susan Gearhart; Keith Lillemoe; Jonas Göhl

doi:10.1007/s10350-005-0268-5

Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection

Victor W. Fazio, Zane Cohen, James W. Fleshman, Harry Van Goor, Joel J. Bauer, Bruce G. Wolff, Marvin Corman, Robert W. Beart, Steven D. Wexner, James M. Becker, John R.T. Monson, Howard S. Kaufman, David E. Beck, H. Randolph Bailey, Kirk A. Ludwig, Michael J. Stamos, Ara Darzi, Ronald Bleday, Richard Dorazio, Robert D. MadoffLee E. Smith, Susan Gearhart, Keith Lillemoe, Jonas Göhl

Research output: Contribution to journal › Article › peer-review

279 Scopus citations

Abstract

INTRODUCTION: 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.

Original language	English (US)
Pages (from-to)	1-11
Number of pages	11
Journal	Diseases of the Colon and Rectum
Volume	49
Issue number	1
DOIs	https://doi.org/10.1007/s10350-005-0268-5
State	Published - Jan 2006

Keywords

Abdominal surgery
Adhesion formation
Adhesive small-bowel obstruction
Carboxymethyl-cellulose
Seprafilm®
Sodium hyaluronate

ASJC Scopus subject areas

Gastroenterology

Access to Document

10.1007/s10350-005-0268-5

Cite this

Fazio, V. W., Cohen, Z., Fleshman, J. W., Van Goor, H., Bauer, J. J., Wolff, B. G., Corman, M., Beart, R. W., Wexner, S. D., Becker, J. M., Monson, J. R. T., Kaufman, H. S., Beck, D. E., Bailey, H. R., Ludwig, K. A., Stamos, M. J., Darzi, A., Bleday, R., Dorazio, R., ... Göhl, J. (2006). Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection. Diseases of the Colon and Rectum, 49(1), 1-11. https://doi.org/10.1007/s10350-005-0268-5

Fazio, VW, Cohen, Z, Fleshman, JW, Van Goor, H, Bauer, JJ, Wolff, BG, Corman, M, Beart, RW, Wexner, SD, Becker, JM, Monson, JRT, Kaufman, HS, Beck, DE, Bailey, HR, Ludwig, KA, Stamos, MJ, Darzi, A, Bleday, R, Dorazio, R, Madoff, RD, Smith, LE, Gearhart, S, Lillemoe, K & Göhl, J 2006, 'Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection', Diseases of the Colon and Rectum, vol. 49, no. 1, pp. 1-11. https://doi.org/10.1007/s10350-005-0268-5

@article{195146539ba94e11b304da7845a63c8f,

title = "Reduction in adhesive small-bowel obstruction by Seprafilm{\textregistered} adhesion barrier after intestinal resection",

abstract = "INTRODUCTION: Although Seprafilm{\textregistered} 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{\textregistered} or no treatment. Seprafilm{\textregistered} 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{\textregistered} 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 {\textregistered} 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{\textregistered}, which was the only factor that predicted this outcome.",

keywords = "Abdominal surgery, Adhesion formation, Adhesive small-bowel obstruction, Carboxymethyl-cellulose, Seprafilm{\textregistered}, Sodium hyaluronate",

author = "Fazio, {Victor W.} and Zane Cohen and Fleshman, {James W.} and {Van Goor}, Harry and Bauer, {Joel J.} and Wolff, {Bruce G.} and Marvin Corman and Beart, {Robert W.} and Wexner, {Steven D.} and Becker, {James M.} and Monson, {John R.T.} and Kaufman, {Howard S.} and Beck, {David E.} and Bailey, {H. Randolph} and Ludwig, {Kirk A.} and Stamos, {Michael J.} and Ara Darzi and Ronald Bleday and Richard Dorazio and Madoff, {Robert D.} and Smith, {Lee E.} and Susan Gearhart and Keith Lillemoe and Jonas G{\"o}hl",

note = "Funding Information: Supported by a grant from Genzyme Corporation, which manufacturers Seprafilm.",

year = "2006",

month = jan,

doi = "10.1007/s10350-005-0268-5",

language = "English (US)",

volume = "49",

pages = "1--11",

journal = "Diseases of the Colon and Rectum",

issn = "0012-3706",

publisher = "Lippincott Williams and Wilkins",

number = "1",

}

TY - JOUR

T1 - Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection

AU - Fazio, Victor W.

AU - Cohen, Zane

AU - Fleshman, James W.

AU - Van Goor, Harry

AU - Bauer, Joel J.

AU - Wolff, Bruce G.

AU - Corman, Marvin

AU - Beart, Robert W.

AU - Wexner, Steven D.

AU - Becker, James M.

AU - Monson, John R.T.

AU - Kaufman, Howard S.

AU - Beck, David E.

AU - Bailey, H. Randolph

AU - Ludwig, Kirk A.

AU - Stamos, Michael J.

AU - Darzi, Ara

AU - Bleday, Ronald

AU - Dorazio, Richard

AU - Madoff, Robert D.

AU - Smith, Lee E.

AU - Gearhart, Susan

AU - Lillemoe, Keith

AU - Göhl, Jonas

N1 - Funding Information: Supported by a grant from Genzyme Corporation, which manufacturers Seprafilm.

PY - 2006/1

Y1 - 2006/1

N2 - INTRODUCTION: 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.

AB - INTRODUCTION: 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.

KW - Abdominal surgery

KW - Adhesion formation

KW - Adhesive small-bowel obstruction

KW - Carboxymethyl-cellulose

KW - Seprafilm®

KW - Sodium hyaluronate

UR - http://www.scopus.com/inward/record.url?scp=29244468515&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=29244468515&partnerID=8YFLogxK

U2 - 10.1007/s10350-005-0268-5

DO - 10.1007/s10350-005-0268-5

M3 - Article

C2 - 16320005

AN - SCOPUS:29244468515

SN - 0012-3706

VL - 49

SP - 1

EP - 11

JO - Diseases of the Colon and Rectum

JF - Diseases of the Colon and Rectum

IS - 1

ER -

Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this