NCT02198898

Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery

Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.

Detailed description

Adhesive bowel obstruction is relatively often complication in patients after abdominal surgery Gastric cancer is the most frequent cancer in Korea. The incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy. The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia. Several studies reported efficacy of adhesive preventing agent after colorectal resection. Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction. To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.

Conditions

• Adhesive Intestinal Obstruction

Interventions

Type	Name	Description
DEVICE	GUARDIX-SG

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-01-01
• Completion: 2017-08-01
• First posted: 2014-07-24
• Last updated: 2017-08-16

Locations

1 site across 1 country: South Korea