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Prevention of Postoperative Abdominal Adhesions by a Novel, Glycerol/Sodium Hyaluronate/Carboxymethylcellulose-Based Bioresorbable Membrane: A Prospective, Randomized, Evaluator-Blinded Multicenter Study

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Diseases of the Colon & Rectum

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.

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Author information

Authors and Affiliations

  1. Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, Canada

    Zane Cohen M.D.

  2. Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio

    Anthony J. Senagore M.D.

  3. Department of Surgery, SUNY at Buffalo, Buffalo, New York

    Merril T. Dayton M.D.

  4. Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

    Mark J. Koruda M.D.

  5. Department of Colon and Rectal Surgery, Ochsner Clinic Foundation, New Orleans, Louisiana

    David E. Beck M.D.

  6. Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota

    Bruce G. Wolff M.D.

  7. Division of Colon and Rectal Surgery, Cedars-Sinai Medical Center, Los Angeles, California

    Phillip R. Fleshner M.D.

  8. Department of Surgery, Virginia Mason Medical Center, Seattle, Washington

    Richard C. Thirlby M.D.

  9. Department of Surgery, Duke University, Durham, North Carolina

    Kirk A. Ludwig M.D.

  10. Department of Colon and Rectal Surgery, Florida Hospital, Colon and Rectal Disease Center, Orlando, Florida

    Sergio W. Larach M.D.

  11. Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Westin, Florida

    Eric G. Weiss M.D.

  12. Department of Surgery, Mt. Sinai Hospital, New York, New York

    Joel J. Bauer M.D.

  13. Genzyme Corporation, Cambridge, Massachusetts

    Lena Holmdahl M.D., Ph.D.

Authors
  1. Zane Cohen M.D.
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  2. Anthony J. Senagore M.D.
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  3. Merril T. Dayton M.D.
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  4. Mark J. Koruda M.D.
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  5. David E. Beck M.D.
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  6. Bruce G. Wolff M.D.
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  7. Phillip R. Fleshner M.D.
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  8. Richard C. Thirlby M.D.
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  9. Kirk A. Ludwig M.D.
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  10. Sergio W. Larach M.D.
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  11. Eric G. Weiss M.D.
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  12. Joel J. Bauer M.D.
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  13. Lena Holmdahl M.D., Ph.D.
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Corresponding author

Correspondence to David E. Beck M.D..

Additional information

Supported in full by grants from Genzyme Corporation, Cambridge, Massachusetts.

Lena Holmdahl, M.D., Ph.D. is an employee of Genzyme Corporation.

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Cohen, Z., Senagore, A., Dayton, M. et al. Prevention of Postoperative Abdominal Adhesions by a Novel, Glycerol/Sodium Hyaluronate/Carboxymethylcellulose-Based Bioresorbable Membrane: A Prospective, Randomized, Evaluator-Blinded Multicenter Study. Dis Colon Rectum 48, 1130–1139 (2005). https://doi.org/10.1007/s10350-004-0954-8

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