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

August 14, 2017 updated by: Kyo Young Song, The Catholic University of Korea

Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 years after operation (every 3 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Kyo Young Song, M.D., The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 29, 2013

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUMCGC1301
  • GUARDIXGASTRIC (Other Identifier: The Catholic University of Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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