Adhesive Intestinal Obstruction
Conditions
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.
Interventions
DEVICEGUARDIX-SG
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed