Efficacy of an antiadhesive agent for the prevention of intra-abdominal adhesions after radical gastrectomy
| Autor: | Hae Myung Jeon, Wook Ro Kim, Han Mo Yoo, Hyung Min Jin, Dong Jin Kim, Han Hong Lee, Kyo Young Song, Cho Hyun Park, Eun Young Kim, Sung Geun Kim, Jeong Gu Kim, Jun Hyun Lee, Kyung Hwa Jeon |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
business.industry medicine.medical_treatment General Medicine Anastomosis medicine.disease law.invention Surgery Bowel obstruction 03 medical and health sciences 0302 clinical medicine medicine.anatomical_structure Randomized controlled trial law 030220 oncology & carcinogenesis Multicenter trial Clinical endpoint Medicine Abdomen Cumulative incidence Gastrectomy 030212 general & internal medicine business |
| Zdroj: | Medicine. 98:e15141 |
| ISSN: | 1536-5964 0025-7974 |
| DOI: | 10.1097/md.0000000000015141 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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