1. Efficacy of an antiadhesive agent for the prevention of intra-abdominal adhesions after radical gastrectomy: A prospective randomized, multicenter trial.
- Author
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Kim SG, Song KY, Lee HH, Kim EY, Lee JH, Jeon HM, Jeon KH, Jin HM, Kim DJ, Kim W, Yoo HM, Kim JG, and Park CH
- Subjects
- Abdomen, Adenocarcinoma epidemiology, Adenocarcinoma surgery, Carboxymethylcellulose Sodium adverse effects, Drug Combinations, Female, Humans, Hyaluronic Acid adverse effects, Incidence, Intestinal Obstruction epidemiology, Intestinal Obstruction etiology, Male, Middle Aged, Postoperative Complications epidemiology, Protective Agents adverse effects, Stomach Neoplasms epidemiology, Stomach Neoplasms surgery, Tissue Adhesions epidemiology, Tissue Adhesions etiology, Carboxymethylcellulose Sodium therapeutic use, Gastrectomy, Hyaluronic Acid therapeutic use, Intestinal Obstruction prevention & control, Postoperative Complications prevention & control, Protective Agents therapeutic use, Tissue Adhesions prevention & control
- Abstract
Background: Guardix-SG is a poloxamer-based antiadhesive agent. The aim of this study was to investigate its efficacy in preventing abdominal adhesions in gastric cancer patients undergoing gastrectomy. Few clinical studies have reported that antiadhesive agent reduces the incidence of adhesion after gastrectomy., Methods: We conducted a multicenter trial from June 2013 and August 2015 in patients with gastric adenocarcinoma undergoing radical gastrectomy. Patients were randomly assigned to the Guardix treatment or control group. Postoperative adhesions were diagnosed based on postoperative symptoms, plain x-ray films, and computed tomography. The primary endpoint of the study was the incidence of small bowel obstruction in the first postoperative year. The secondary end-point was the safety of Guardix-SG., Results: The study included 109 patients in the Guardix group and 105 patients in the control group. The groups were similarly matched with pathological stage, operation type, anastomosis method, midline incision length, and the extent of lymph node dissection. Eight in the Guardix group and 21 in the control group experienced intestinal obstruction during the 1-year follow-up period. The cumulative incidence of small bowel obstruction was significantly lower in the Guardix group compared to that seen in the control group (4.7% vs 8.6% at 6 months and 7.3% vs 20% at 1 year; P = .007, log-rank test). There were no differences in postoperative complications and adverse events., Conclusion: Guardix-SG significantly decreased the incidence of intestinal obstruction without affecting the incidence of postoperative complications.
- Published
- 2019
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