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Published in: International Journal of Colorectal Disease 3/2009

01-03-2009 | Original Article

Sodium hyaluronate-based bioresorbable membrane (Seprafilm®) reduced early postoperative intestinal obstruction after lower abdominal surgery for colorectal cancer: the preliminary report

Authors: Chi-Min Park, Woo Yong Lee, Yong Beom Cho, Hae Ran Yun, Won-Suk Lee, Seong Hyeon Yun, Ho-Kyung Chun

Published in: International Journal of Colorectal Disease | Issue 3/2009

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Abstract

Purposes

This study is a prospective randomized clinical trial to evaluate the clinical safety and the effect of a sodium hyaluronate-based bioresorbable membrane (Seprafilm®; Genzyme, Cambridge, MA, USA) for reducing adhesive intestinal obstruction after colorectal cancer surgery.

Materials and methods

Between November 2002 and December 2003, 504 patients underwent radical resection for sigmoid or rectal cancer. Among these patients, 427 patients were enrolled in this study. The patients were randomized into the Seprafilm® group (N = 185) and the control group (N = 242). All the patients in the Seprafilm® group received one sheet of Seprafilm® over the pelvic inlet where the peritoneum was denuded due to pelvic dissection. Intestinal obstruction was defined when there were symptoms of nausea, vomiting, and abdominal distension combined with an obstructive bowel pattern on the radiologic evaluation.

Results

The median follow-up period was 25.0 months. There were no significant differences between the Seprafilm® and the control groups for the clinicopathologic parameters. There were no differences in the incidence of complications between the two groups; however, the incidence of early postoperative intestinal obstruction was significantly less in the Seprafilm® group than in the control group (2.7% vs 7.0%, respectively, p = 0.045). Five patients in the Seprafilm® group experienced postoperative intestinal obstruction (2.7%) compared with 11 patients in the control group (4.6%) during the follow-up period; however, there was no statistical difference.

Conclusions

Seprafilm® appears to be effective in preventing early postoperative intestinal obstruction and there was a trend for reduced intestinal obstruction after lower abdominal surgery for colorectal cancer.
Literature
1.
go back to reference Menzies D, Ellis H (1990) Intestinal onstruction from adhesions: how big is the problem? Ann R Coll Surg Engl 72:60–63PubMed Menzies D, Ellis H (1990) Intestinal onstruction from adhesions: how big is the problem? Ann R Coll Surg Engl 72:60–63PubMed
2.
go back to reference Weibel MA, Majno G (1973) Peritoneal adhesions and their relation to abdominal surgery. Am J Surg 126:345–353PubMedCrossRef Weibel MA, Majno G (1973) Peritoneal adhesions and their relation to abdominal surgery. Am J Surg 126:345–353PubMedCrossRef
3.
go back to reference Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A et al (1999) Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet 353:1476–1480PubMedCrossRef Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A et al (1999) Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet 353:1476–1480PubMedCrossRef
4.
go back to reference Ellis H (1997) The clinical significance of adhesion: focus on intestinal obstruction. Eur J Surg 163(suppl):5–9 Ellis H (1997) The clinical significance of adhesion: focus on intestinal obstruction. Eur J Surg 163(suppl):5–9
5.
go back to reference Menzies D (1993) Prospective adhesions: their treatment and relevance in clinical practice. Ann R Coll Surg Engl 75:147–153PubMed Menzies D (1993) Prospective adhesions: their treatment and relevance in clinical practice. Ann R Coll Surg Engl 75:147–153PubMed
6.
go back to reference Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL (1999) Incidnece of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum 42:241–248PubMedCrossRef Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL (1999) Incidnece of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum 42:241–248PubMedCrossRef
7.
go back to reference Chen SW, Liang JA, Yang SN, Hung YC, Yeh LS, Shiau AC, Lin FJ (2004) Radiation injury to intestine following hysterectomy and adjuvant radiotherapy for cervical cancer. Gynecol Oncol 95:208–214PubMedCrossRef Chen SW, Liang JA, Yang SN, Hung YC, Yeh LS, Shiau AC, Lin FJ (2004) Radiation injury to intestine following hysterectomy and adjuvant radiotherapy for cervical cancer. Gynecol Oncol 95:208–214PubMedCrossRef
8.
go back to reference Burgess L, Greenawalt K, Rowe E, Burns J, Skrabut E (1999) Evaluation of a plasticized sodium hyaluronate/carboxymethylcellulose adhesion barrier. Society for Biomaterials. 25th Annual Meeting Transactions 169 Burgess L, Greenawalt K, Rowe E, Burns J, Skrabut E (1999) Evaluation of a plasticized sodium hyaluronate/carboxymethylcellulose adhesion barrier. Society for Biomaterials. 25th Annual Meeting Transactions 169
9.
go back to reference Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG et al (1996) Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg 183:297–306PubMed Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG et al (1996) Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg 183:297–306PubMed
10.
go back to reference Diamond MP, Seprafilm® Adhesion Study Group (1996) Reduction of adhesion s after uterine myomectomy by Seprafilm® membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil Steril 66:904–910PubMed Diamond MP, Seprafilm® Adhesion Study Group (1996) Reduction of adhesion s after uterine myomectomy by Seprafilm® membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil Steril 66:904–910PubMed
11.
go back to reference Tang CL, Seow-Choen F, Fook-Chong S, Eu KW (2003) Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision. Dis Colon Rectum 46:1200–1207PubMedCrossRef Tang CL, Seow-Choen F, Fook-Chong S, Eu KW (2003) Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision. Dis Colon Rectum 46:1200–1207PubMedCrossRef
12.
13.
go back to reference Ray NF, Larsen JW, Stillman RJ, Jacobs RJ (1993) Economic impact of hospitalizations for lover abdominal adhesiolysis in the United States in 1988. Surg Gynecol Obstet 176:271–276PubMed Ray NF, Larsen JW, Stillman RJ, Jacobs RJ (1993) Economic impact of hospitalizations for lover abdominal adhesiolysis in the United States in 1988. Surg Gynecol Obstet 176:271–276PubMed
14.
go back to reference HCIA Inc. (1994) Peritoneal adhesiolysis. National Inpatients Profile 1993, Baltimore, pp 653–655 HCIA Inc. (1994) Peritoneal adhesiolysis. National Inpatients Profile 1993, Baltimore, pp 653–655
15.
go back to reference Liakakos T, Thomakos N, Fine PM, Dervenis C, Young RL (2001) Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Dig Surg 18:260–273PubMedCrossRef Liakakos T, Thomakos N, Fine PM, Dervenis C, Young RL (2001) Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Dig Surg 18:260–273PubMedCrossRef
16.
go back to reference Sahakian V, Rodgers RG, Halme J, Hulka J (1993) Effects of carbon dioxide saturated normal saline and Ringer’s lactate on postsurgical adhesion formation in the rabbit. Obstet Gynecol 82:851–853PubMed Sahakian V, Rodgers RG, Halme J, Hulka J (1993) Effects of carbon dioxide saturated normal saline and Ringer’s lactate on postsurgical adhesion formation in the rabbit. Obstet Gynecol 82:851–853PubMed
17.
go back to reference diZerega GS (1994) Contemporary adhesions prevention. Fertil Steril 61:219–235PubMed diZerega GS (1994) Contemporary adhesions prevention. Fertil Steril 61:219–235PubMed
18.
go back to reference Urman B, Gomel V, Jetha N (1991) Effect of hyaluronic acid on postoperative intraperitoneal adhesion formation in the rat model. Fertil Steril 56:563–567PubMed Urman B, Gomel V, Jetha N (1991) Effect of hyaluronic acid on postoperative intraperitoneal adhesion formation in the rat model. Fertil Steril 56:563–567PubMed
19.
go back to reference Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP (1995) Prevention of tissue injury and postsurgical adhesions by precoating tissue with hyaluronic acid solutions. J Surg Res 59:644–652PubMedCrossRef Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP (1995) Prevention of tissue injury and postsurgical adhesions by precoating tissue with hyaluronic acid solutions. J Surg Res 59:644–652PubMedCrossRef
20.
go back to reference DeCherney AH, diZerega GS (1997) Clinical problem of intraperitoneal postsurgical adhesion formation following general surgery and the use of adhesion prevention barriers. Surg Clin North Am 77:671–688PubMedCrossRef DeCherney AH, diZerega GS (1997) Clinical problem of intraperitoneal postsurgical adhesion formation following general surgery and the use of adhesion prevention barriers. Surg Clin North Am 77:671–688PubMedCrossRef
21.
go back to reference Larsson B, Nisell H, Granberg I (1978) Surgicel—an absorbable hemostatic material—in prevention of peritoneal adhesions in rats. Acta Chir Scand 144:375–378PubMed Larsson B, Nisell H, Granberg I (1978) Surgicel—an absorbable hemostatic material—in prevention of peritoneal adhesions in rats. Acta Chir Scand 144:375–378PubMed
22.
go back to reference The Surgical Membrane Study Group (1992) Prophylaxis of pelvic side wall adhesions with Gore-Tex surgical membrane: a multicenter clinical investigation. Fertil Steril 57:921–923 The Surgical Membrane Study Group (1992) Prophylaxis of pelvic side wall adhesions with Gore-Tex surgical membrane: a multicenter clinical investigation. Fertil Steril 57:921–923
23.
go back to reference INTERCEED (TC7) Adhesions Barrier Study Group (1989) Prevention of postsurgical adhesions by intercede (TC7), an absorbable adhesion barrier: a prospective, randomized multicenter clinical study. Fertil Steril 51:933–938 INTERCEED (TC7) Adhesions Barrier Study Group (1989) Prevention of postsurgical adhesions by intercede (TC7), an absorbable adhesion barrier: a prospective, randomized multicenter clinical study. Fertil Steril 51:933–938
24.
go back to reference Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG (2003) A prospective, randomized, multicenter, controlled study of the safety of Sepraflim® adhesion barrier in abdominaopelvic surgery of the intestine. Dis Colon Rectum 46:1310–1319PubMedCrossRef Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG (2003) A prospective, randomized, multicenter, controlled study of the safety of Sepraflim® adhesion barrier in abdominaopelvic surgery of the intestine. Dis Colon Rectum 46:1310–1319PubMedCrossRef
25.
go back to reference Salum MR, Lam DT, Wexner SD, Pilkarsky A, Baig MK, Weiss EG, Nogueras JJ et al (2001) Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm®) have possible short-term beneficial impact? Dis Colon Rectum 44:706–712PubMedCrossRef Salum MR, Lam DT, Wexner SD, Pilkarsky A, Baig MK, Weiss EG, Nogueras JJ et al (2001) Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm®) have possible short-term beneficial impact? Dis Colon Rectum 44:706–712PubMedCrossRef
26.
go back to reference Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M et al (2006) Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection. Dis Colon Rectum 49:1–11PubMedCrossRef Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M et al (2006) Reduction in adhesive small-bowel obstruction by Seprafilm® adhesion barrier after intestinal resection. Dis Colon Rectum 49:1–11PubMedCrossRef
27.
go back to reference Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, Uchida K et al (2005) Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm®) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today 35:940–945PubMedCrossRef Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, Uchida K et al (2005) Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm®) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today 35:940–945PubMedCrossRef
28.
go back to reference Oikonomakis I, Wexner SD, Gervaz P, You SY, Secic M, Giamundo P (2002) Seprafilm®: a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancer. Dis Colon Rectum 45:1376–1380PubMedCrossRef Oikonomakis I, Wexner SD, Gervaz P, You SY, Secic M, Giamundo P (2002) Seprafilm®: a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancer. Dis Colon Rectum 45:1376–1380PubMedCrossRef
29.
go back to reference Oncel M, Remzi FH, Senagore AJ, Connor JT, Fazio VW (2003) Comparison of a novel liquid (Adcon-P®) and a sodium hyaluronate and carboxymethylcellulose membrane (Seprafilm™) in postsurgical adhesion formation in a murine model. Dis Colon Rectum 46:187–191PubMedCrossRef Oncel M, Remzi FH, Senagore AJ, Connor JT, Fazio VW (2003) Comparison of a novel liquid (Adcon-P®) and a sodium hyaluronate and carboxymethylcellulose membrane (Seprafilm™) in postsurgical adhesion formation in a murine model. Dis Colon Rectum 46:187–191PubMedCrossRef
Metadata
Title
Sodium hyaluronate-based bioresorbable membrane (Seprafilm®) reduced early postoperative intestinal obstruction after lower abdominal surgery for colorectal cancer: the preliminary report
Authors
Chi-Min Park
Woo Yong Lee
Yong Beom Cho
Hae Ran Yun
Won-Suk Lee
Seong Hyeon Yun
Ho-Kyung Chun
Publication date
01-03-2009
Publisher
Springer-Verlag
Published in
International Journal of Colorectal Disease / Issue 3/2009
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-008-0602-1

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