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Efficacy of an antiadhesive agent for the prevention of intra-abdominal adhesions after radical gastrectomy: A prospective randomized, multicenter trial.

Authors :
Kim SG
Song KY
Lee HH
Kim EY
Lee JH
Jeon HM
Jeon KH
Jin HM
Kim DJ
Kim W
Yoo HM
Kim JG
Park CH
Source :
Medicine [Medicine (Baltimore)] 2019 May; Vol. 98 (19), pp. e15141.
Publication Year :
2019

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.<br />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.<br />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; Pā€Š=ā€Š.007, log-rank test). There were no differences in postoperative complications and adverse events.<br />Conclusion: Guardix-SG significantly decreased the incidence of intestinal obstruction without affecting the incidence of postoperative complications.

Details

Language :
English
ISSN :
1536-5964
Volume :
98
Issue :
19
Database :
MEDLINE
Journal :
Medicine
Publication Type :
Academic Journal
Accession number :
31083151
Full Text :
https://doi.org/10.1097/MD.0000000000015141