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

Phase 3

• Conditions: Adhesive Intestinal Obstruction
• Interventions: Device: GUARDIX-SG

• Registration Number: NCT02198898
• Lead Sponsor: The Catholic University of Korea

Brief 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.

Study Timeline

• Study First Submitted: 2013-06-29
• Study Start: 2013-07
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-24
• Primary Completion: 2016-01
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
• Informed consents

Exclusion Criteria

• Pregnant
• Ascites
• Liver dysfunction
• Renal failure
• Past history of abdominal operation or small bowel obstruction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guadix	GUARDIX-SG	guadix treatment

Primary Outcome Measures

Name	Time	Method
incidence of adhesive intestinal obstruction	up to 1 years after operation (every 3 month)	the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of