TRANSIT study
Phase 3
Recruiting
- Conditions
- Obstructive colorectal cancer
- Registration Number
- JPRN-jRCT1042210155
- Lead Sponsor
- Hotta Kinichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 215
Inclusion Criteria
1) Obstructive colorectal cancer except cecum and ascending colon
2) After insertion of self-expandable metal stent
3) 20 years and older
4) Written informed consent is obtained
Exclusion Criteria
1) Performance Status 3 or higher
2) Colorectal Obstructive Scoring System 0-1
3) Difficulty in taking oral bowel preparation
4) Fever of 38.0 or higher or abdominal pain
5) No immediate surgery planned
6) Inappropriate cases by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection rate of synchronous colorectal cancer in the proximal side
- Secondary Outcome Measures
Name Time Method (1) Cecal intubation rate<br>(2) Percentage and number of colorectal neoplastic lesions detected by colonoscopy<br>(3) Comparison with colorectal lesions detected by other imaging tests<br>(4) The number needed to scope in advanced neoplasia<br>(5) Adverse events<br>(6) Change rate of operative method<br>(7) Synchronous colorectal cancer detected by postoperative surveillance colonoscopy