Back to resultsRandomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Primary Purpose
Patient Under Going Colorectal and Stomach Cancer Surgery
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Guardix
Seprafilm
Sponsored by
About this trial
This is an interventional treatment trial for Patient Under Going Colorectal and Stomach Cancer Surgery
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of GI cancer
- Operable
Exclusion Criteria:
- Withdrew consent
- Pregnant
- Ascites
- Distant metastasis
- Liver dysfunction (serum total bilirubin >2.0 mg/dL)
- Renal failure (serum creatinine >1.5 mg/dL)
- A past history of small bowel obstruction.
Sites / Locations
- Won-Suk Lee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Guardix
Seprafilm
Arm Description
6g per body
1 sheet per body
Outcomes
Primary Outcome Measures
ileus rate
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Secondary Outcome Measures
adverse effect rate
Full Information
NCT ID
NCT02168426
First Posted
June 18, 2014
Last Updated
August 28, 2015
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02168426
Brief Title
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Official Title
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Under Going Colorectal and Stomach Cancer Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guardix
Arm Type
Active Comparator
Arm Description
6g per body
Arm Title
Seprafilm
Arm Type
Active Comparator
Arm Description
1 sheet per body
Intervention Type
Procedure
Intervention Name(s)
Guardix
Other Intervention Name(s)
Guardix, Sami pharmaceutical company, Seprafilm
Intervention Description
Applying 6g of guardix during abdominal surgery
Intervention Type
Procedure
Intervention Name(s)
Seprafilm
Intervention Description
Applying 1 sheet of seprafilm during abdominal surgery
Primary Outcome Measure Information:
Title
ileus rate
Description
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Time Frame
within 60 days
Secondary Outcome Measure Information:
Title
adverse effect rate
Time Frame
within 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of GI cancer
Operable
Exclusion Criteria:
Withdrew consent
Pregnant
Ascites
Distant metastasis
Liver dysfunction (serum total bilirubin >2.0 mg/dL)
Renal failure (serum creatinine >1.5 mg/dL)
A past history of small bowel obstruction.
Facility Information:
Facility Name
Won-Suk Lee
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
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