Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT02198898|
Recruitment Status : Unknown
Verified August 2017 by Kyo Young Song, The Catholic University of Korea.
Recruitment status was: Active, not recruiting
First Posted : July 24, 2014
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adhesive Intestinal Obstruction||Device: GUARDIX-SG||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||August 2017|
No Intervention: GUARDIX
- incidence of adhesive intestinal obstruction [ Time Frame: up to 1 years after operation (every 3 month) ]the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198898
|Korea, Republic of|
|Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of, 137701|
|Principal Investigator:||Kyo Young Song, M.D.||The Catholic University of Korea|