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

NCT ID: NCT02198898

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-08-31

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.

Conditions

Adhesive Intestinal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

GUARDIX

no guadix

Group Type: NO_INTERVENTION

No interventions assigned to this group

guadix

guadix treatment

Group Type: EXPERIMENTAL

GUARDIX-SG

Intervention Type: DEVICE

Interventions

GUARDIX-SG

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Kyo Young Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyo Young Song, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GUARDIXGASTRIC

Identifier Type: OTHER

Identifier Source: secondary_id

CUMCGC1301

Identifier Type: -

Identifier Source: org_study_id