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

Adhesive Intestinal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02198898
• Other study ID #: CUMCGC1301
• Secondary ID: GUARDIXGASTRIC
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 29, 2013
• Last updated: August 14, 2017
• Start date: July 2013
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: August 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Intestinal Obstruction
• Intestinal Obstruction
• Stomach Neoplasms

Intervention

Device:
• GUARDIX-SG

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adhesive intestinal obstruction	the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group	up to 1 years after operation (every 3 month)