Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery
Conditions
Adhesive Intestinal Obstruction
Conditions: official terms
Intestinal Obstruction
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Intervention
Name: GUARDIX-SG
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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
Location
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Kyo Young Song, M.D. - +82222586106 - skys9615@gmail.com
Start Date
July 2013
Completion Date
August 2015
Sponsors
The Catholic University of Korea
Source
The Catholic University of Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page