NCT02198898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

June 29, 2013

Last Update Submit

August 14, 2017

Conditions

Adhesive Intestinal Obstruction

Outcome Measures

Primary Outcomes (1)

  • incidence of adhesive intestinal obstruction

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

    up to 1 years after operation (every 3 month)

Study Arms (2)

GUARDIX

NO INTERVENTION

no guadix

guadix

EXPERIMENTAL

guadix treatment

Device: GUARDIX-SG

Interventions

GUARDIX-SGDEVICE
guadix

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
  • Informed consents

You may not qualify if:

  • Pregnant
  • Ascites
  • Liver dysfunction
  • Renal failure
  • Past history of abdominal operation or small bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137701, South Korea

Location

Study Officials

  • Kyo Young Song, M.D.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2013

First Posted

July 24, 2014

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

August 1, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

KR(1)