Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Conditions
Patient Under Going Colorectal and Stomach Cancer Surgery
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Guardix Type: Procedure
Name: Seprafilm Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 25 Years
Gender: Both
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.
Location
Won-Suk Lee
Incheon, Korea, Republic of
Status: Recruiting
Contact: Won-Suk Lee, MD - 82-32-460-3272 - lws@gilhospital.com
Start Date
August 2013
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page