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

Primary Purpose

Adhesive Intestinal Obstruction

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GUARDIX-SG
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adhesive Intestinal Obstruction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

GUARDIX

guadix

Arm Description

no guadix

guadix treatment

Outcomes

Primary Outcome Measures

incidence of adhesive intestinal obstruction
the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group

Secondary Outcome Measures

Full Information

First Posted
June 29, 2013
Last Updated
August 14, 2017
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02198898
Brief Title
Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery
Official Title
Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Intestinal Obstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GUARDIX
Arm Type
No Intervention
Arm Description
no guadix
Arm Title
guadix
Arm Type
Experimental
Arm Description
guadix treatment
Intervention Type
Device
Intervention Name(s)
GUARDIX-SG
Primary Outcome Measure Information:
Title
incidence of adhesive intestinal obstruction
Description
the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group
Time Frame
up to 1 years after operation (every 3 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyo Young Song, M.D.
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137701
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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