Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: a prospective, randomized, evaluator-blinded multicenter study.
BACKGROUND
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 anti-adhesion 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.
Cohen
Zane
Z
Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, Canada.
Senagore
Anthony J
AJ
Dayton
Merril T
MT
Koruda
Mark J
MJ
Beck
David E
DE
Wolff
Bruce G
BG
Fleshner
Phillip R
PR
Thirlby
Richard C
RC
Ludwig
Kirk A
KA
Larach
Sergio W
SW
Weiss
Eric G
EG
Bauer
Joel J
JJ
Holmdahl
Lena
L
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials; D002266:Carboxymethylcellulose Sodium; D039021:Colonic Pouches; D005260:Female; D005990:Glycerol / Q000008:administration & dosage*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007081:Ileostomy / Q000009:adverse effects; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D010532:Peritoneal Diseases / Q000209:etiology / Q000517:prevention & control*; D016737:Proctocolectomy, Restorative / Q000009:adverse effects; D011446:Prospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D001672:Biocompatible Materials; D008567:Membranes, Artificial; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium; D005990:Glycerol