Patients who are scheduled to undergo colostomy during laparotomy
Conditions
Interventions
E8002 (Adhesion Barrier)
Marketed product
Sponsors
Kawasumi Laboratories, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are aged 20 years or more on the day of signing the consent form 2)Patients undergoing a colectomy or proctectomy with a loop ileostomy or a loop colostomy under laparotomy (initial surgery), and are scheduled to undergo a colostomy closure or ileostomy closure 8 to 36 weeks after initial surgery (second surgery) 3)Patients who fully understand the nature of the trial and are able to give the informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The evaluation of adhesions under the midline incision after surgery | — |
Countries
Japan
Contacts
Public ContactMasahiro Tokunaga
Research and Development Division Research and Development Division
Outcome results
None listed