A pilot study of SI-449 adhesion barrier system in patients who are scheduled to undergo temporary ileostomy.
Not Applicable
- Conditions
- Patients with rectal cancer
- Registration Number
- JPRN-UMIN000033294
- Lead Sponsor
- Seikagaku corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Key exclusion criteria, 1.Patients with history of surgery in the abdominal or pelvic cavity. 2.Patients with having active infection in the abdominal or pelvic cavity. 3.Patients with having active or previous history of peritonitis. 4.Patients with history of hypersensitivity to the investigational device. 5.Patients with a serious hepatic or a serious renal disorder 6.Patients who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent 7.Any circumstances or conditions, which, in the opinion of the principal investigator or sub-investigator, may affect participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events, Laboratory tests and manageability
- Secondary Outcome Measures
Name Time Method The incidence of adhesions after surgery