Randomized Controlled Trial in efficacy and safety of E8002
- Conditions
- Patients who are scheduled to undergo colostomy during laparotomy
- Registration Number
- JPRN-UMIN000028910
- Lead Sponsor
- Kawasumi Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 151
Not provided
1)Patients with laparoscopy used in the initial surgery 2)Patients who have to be administrated the following drugs intraperitoneally from 24 hours pre-surgery to 7 days post-surgery: steroids, heparin, low molecular weight heparin, salicylates, nonsteroidal anti-inflammatory drugs, Dextran 70, or antibiotic fluids 3)Patients who have a previous abdominal midline incision 4)Patients having a current diagnostic of peritonitis 5)Patients who currently have gastrointestinal perforation 6)Patients who are subject to emergency operation 7)Patients with metastatic cancers 8)Patients with ECOG performance status of 2 or greater 9)Patients who have severe drug allergy history 10)Patients who have specific drug allergy history to pullulan, poly (lactide-glycolide-caprolactone), ascorbic acid, sodium hyaluronate, and carboxymethyl cellulose 11)Patients who currently have systemic infections 12)Patients who are pregnant, lactating mothers, or wanting to become pregnant during clinical trials 13)Patients who are considered a life expectancy of less than one year 14)Patients who have participated in other interventional clinical trials within 30 days from the informed consent, or patients who are currently participating in other interventional clinical trials 15)Patients who have been determined as inappropriate for the trial by the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method