Adhesive Intestinal ObstructionPhase 3NCT02198898
Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery
A Phase 3 study testing GUARDIX-SG in people with Adhesive Intestinal Obstruction, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Adhesive Intestinal Obstruction
- What is being tested?
- GUARDIX-SG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
- Informed consents
Who cannot join
- Pregnant
- Ascites
- Liver dysfunction
- Renal failure
- Past history of abdominal operation or small bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adhesive Intestinal Obstruction
- Being tested
- GUARDIX-SG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUARDIX-SGDevice
| Study group | Role | What they receive |
|---|---|---|
| GUARDIX | No intervention | no guadix |
| guadix | Experimental | guadix treatment Receives: Device: GUARDIX-SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adhesive intestinal obstruction
the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group
Measured: up to 1 years after operation (every 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Intestinal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyo Young Song, The Catholic University of Korea
- Investigators
- Kyo Young Song, M.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198898
- Sponsor's protocol ID
- CUMCGC1301
- Other IDs
- GUARDIXGASTRIC
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2013
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.
- ClinicalTrials.gov ID
- NCT02198898
- Acronym / sponsor ID
- CUMCGC1301
- Conditions
- Adhesive Intestinal Obstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUARDIX | No intervention | –no guadix |
| guadix | Experimental | Device: GUARDIX-SGguadix treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
- Informed consents
Key exclusion criteria (5 listed)
- Pregnant
- Ascites
- Liver dysfunction
- Renal failure
- Past history of abdominal operation or small bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUARDIX-SG | Device | guadix |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyo Young Song, M.D. principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GUARDIX-SG in people with Adhesive Intestinal Obstruction, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adhesive intestinal obstruction (time frame: up to 1 years after operation (every 3 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.