Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: A prospective, randomized, evaluator-blinded multicenter study

Zane Cohen, Anthony J. Senagore, Merril T. Dayton, Mark J. Koruda, David E. Beck, Bruce G. Wolff, Phillip R. Fleshner, Richard C. Thirlby, Kirk A. Ludwig, Sergio W. Larach, Eric G. Weiss, Joel J. Bauer, Lena Holmdahl

Research output: Contribution to journalArticle

75 Citations (Scopus)

Abstract

INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/ carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no antiadhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P <0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/ carboxymethylcellulose than with control (P <0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.

Original languageEnglish (US)
Pages (from-to)1130-1139
Number of pages10
JournalDiseases of the Colon and Rectum
Volume48
Issue number6
DOIs
StatePublished - Jun 2005
Externally publishedYes

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Carboxymethylcellulose Sodium
Hyaluronic Acid
Glycerol
Multicenter Studies
Membranes
Ileostomy
Control Groups
Therapeutics
Restorative Proctocolectomy
Safety
Colonic Pouches
Omentum
Incidence
Ulcerative Colitis
Laparoscopy
Abscess
Animal Models
Morbidity
Delivery of Health Care
Mortality

Keywords

  • Adhesions
  • Complications
  • Randomized trial

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane : A prospective, randomized, evaluator-blinded multicenter study. / Cohen, Zane; Senagore, Anthony J.; Dayton, Merril T.; Koruda, Mark J.; Beck, David E.; Wolff, Bruce G.; Fleshner, Phillip R.; Thirlby, Richard C.; Ludwig, Kirk A.; Larach, Sergio W.; Weiss, Eric G.; Bauer, Joel J.; Holmdahl, Lena.

In: Diseases of the Colon and Rectum, Vol. 48, No. 6, 06.2005, p. 1130-1139.

Research output: Contribution to journalArticle

Cohen, Z, Senagore, AJ, Dayton, MT, Koruda, MJ, Beck, DE, Wolff, BG, Fleshner, PR, Thirlby, RC, Ludwig, KA, Larach, SW, Weiss, EG, Bauer, JJ & Holmdahl, L 2005, 'Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: A prospective, randomized, evaluator-blinded multicenter study', Diseases of the Colon and Rectum, vol. 48, no. 6, pp. 1130-1139. https://doi.org/10.1007/s10350-004-0954-8
Cohen, Zane ; Senagore, Anthony J. ; Dayton, Merril T. ; Koruda, Mark J. ; Beck, David E. ; Wolff, Bruce G. ; Fleshner, Phillip R. ; Thirlby, Richard C. ; Ludwig, Kirk A. ; Larach, Sergio W. ; Weiss, Eric G. ; Bauer, Joel J. ; Holmdahl, Lena. / Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane : A prospective, randomized, evaluator-blinded multicenter study. In: Diseases of the Colon and Rectum. 2005 ; Vol. 48, No. 6. pp. 1130-1139.
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T1 - Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane

T2 - A prospective, randomized, evaluator-blinded multicenter study

AU - Cohen, Zane

AU - Senagore, Anthony J.

AU - Dayton, Merril T.

AU - Koruda, Mark J.

AU - Beck, David E.

AU - Wolff, Bruce G.

AU - Fleshner, Phillip R.

AU - Thirlby, Richard C.

AU - Ludwig, Kirk A.

AU - Larach, Sergio W.

AU - Weiss, Eric G.

AU - Bauer, Joel J.

AU - Holmdahl, Lena

PY - 2005/6

Y1 - 2005/6

N2 - INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/ carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no antiadhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P <0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/ carboxymethylcellulose than with control (P <0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.

AB - INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/ carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no antiadhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P <0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/ carboxymethylcellulose than with control (P <0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.

KW - Adhesions

KW - Complications

KW - Randomized trial

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