Patient Under Going Colorectal and Stomach Cancer Surgery Clinical Trial
Official title:
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
| Verified date | August 2015 |
| Source | Gachon University Gil Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | February 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Years to 90 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Won-Suk Lee | Incheon |
| Lead Sponsor | Collaborator |
|---|---|
| Gachon University Gil Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ileus rate | Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations | within 60 days | No |
| Secondary | adverse effect rate | within 60 days | No |