Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) Additional study:Gastrointestinal transit time as an indicator
Phase 3
- Conditions
- Colon cancer (Sigmoidal and Rectosigmoidal regions)
- Registration Number
- JPRN-UMIN000001793
- Lead Sponsor
- Japanese Foundation for Multidisciplinary Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1)Participate in JFMC39-0902
2)Amenable to curative resection in colon cancer (Sigmoidal and Rectosigmoidal regions)
3)Patients who can provide written informed consent
Exclusion Criteria
1)Patients who are unfit for the study as determined by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total number of elimination of the markers
- Secondary Outcome Measures
Name Time Method 1) Time to first flatus (hr) after nasogastric tube removal <br>2) Segmental transit time (gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))