Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Not Applicable
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000010314
- Lead Sponsor
- Kitasato University Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have persistence of cancer macroscopically Patients who are given anticancer drugs intraperitoneally Patients who have sever hapatic damage, kidney damage, heart disease and infection desease Patients who will be used other anti-adhesion methods in both groups including the non-use interceed Patients who will be used over the site that has been soaked in blood Patients who will be used over the contaminated or infected wound Patients who have history of severe drug allergy Patients who have history of oxidized regenerated cellulose allergy Patients who are judged inappropriate by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of serious adverse event within 30 days from surgery.
- Secondary Outcome Measures
Name Time Method Frequency of serious adverse event within 6 months after surgery. Frequency of infection of the surgical site within 30 days and 6 months after surgery. Frequency of adhesive ileus within 30 days and 6 months after surgery. The use of evaluation of the intercede during surgery.