A Randomized Controlled Trial of 0.5% Ferric Hyaluronate Gel (Intergel) in the Prevention of Adhesions Following Abdominal Surgery.

Ann Surg. 2006 Apr;243(4):449-455.
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A Randomized Controlled Trial of 0.5% Ferric Hyaluronate Gel (Intergel) in the Prevention of Adhesions Following Abdominal Surgery.
Tang CL, Jayne DG, Seow-Choen F, Ng YY, Eu KW, Mustapha N.

From the *Department of Colorectal Surgery, Singapore General Hospital, Singapore; and daggerClinical Trials & Epidemiology Research Unit, Ministry of Health, Singapore.

INTRODUCTION:: Intestinal adhesion following abdominal surgery is a significant sequela to abdominal surgery. Intergel is a hyaluronate-based gel that reduces the incidence of postoperative adhesions when added to the peritoneal cavity before closure in gynecologic surgery. This is a randomized controlled trial evaluating the efficacy and safety of Intergel in colorectal resections. Although the study aimed to recruit 200 patients based on power analysis, recruitment was suspended because of the high morbidity in the treatment group.

METHODS:: A total of 32 patients were randomized to either Intergel treatment (treatment group) or no treatment (control group) following open abdominal surgery. Primary endpoints included the incidence of adhesive obstruction, the need for subsequent adhesiolysis, and the incidence of wound and anastomotic complications. A secondary endpoint involved quality-of-life assessment.

RESULTS:: Seventeen patients were randomized to the treatment group and 15 to the control group. All patients, except 1 in the treatment group, underwent resection and anastomosis of the colon or rectum for benign or malignant disease. A significant difference was observed in the number of patients with postoperative morbidities between the 2 groups (65% treatment group versus 27% control group, P = 0.031). There was a high rate of anastomotic dehiscence (5 treatment group versus 1 control group, P = 0.178) and prolonged postoperative ileus (10 treatment group versus 2 control group, P = 0.011) observed in treatment group. One case of peritonitis occurred in the treatment group in the presence of an intact anastomosis. Wound complications were more common in treatment group but failed to reach statistical significance.

CONCLUSION:: The use of Intergel in abdominal surgery where the gastrointestinal tract is opened leads to unacceptably high rates of postoperative complications.PMID: 16552194 [PubMed - as supplied by publisher]