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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
Sponsor:
Information provided by (Responsible Party):
Kyo Young Song, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Adhesive Intestinal Obstruction Device: GUARDIX-SG Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: GUARDIX
no guadix
Experimental: guadix
guadix treatment
Device: GUARDIX-SG



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137701
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Principal Investigator: Kyo Young Song, M.D. The Catholic University of Korea
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Responsible Party: Kyo Young Song, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02198898    
Other Study ID Numbers: CUMCGC1301
GUARDIXGASTRIC ( Other Identifier: The Catholic University of Korea )
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases