Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Phase 3
Completed
- Conditions
- Patient Under Going Colorectal and Stomach Cancer Surgery
- Registration Number
- NCT02168426
- Lead Sponsor
- Gachon University Gil Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ileus rate within 60 days Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
- Secondary Outcome Measures
Name Time Method adverse effect rate within 60 days
Trial Locations
- Locations (1)
Won-Suk Lee
🇰🇷Incheon, Korea, Republic of
Won-Suk Lee🇰🇷Incheon, Korea, Republic of