Clinical effectiveness of daikenchuto (TJ-100) on gastrointestinal symptom after colectomy in colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder.
- Conditions
- Colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder.
- Registration Number
- JPRN-UMIN000008348
- Lead Sponsor
- Osaka Police Hospital
- Brief Summary
The numbers of bowel movements per day on postoperative days (PODs) 1, 2, and 6 were significantly lower in the DKT group. The presence of the sensation of incomplete bowel evacuation on PODs 3 and 28 was significantly lower in the DKT group. There were no adverse events due to or suspected to be related to DKT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
In order to participate in this study, a patient must not meet any of the following criteria.1) Patients with history or at present of chemotherapy and/or radiotherapy for primary disease.2) Patients with lower colectory.3) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease.4) Patients with cancerous peritonitis.5) Patients with organic leasion of hepato-biliary-pancreatic (gallstone, hepatitis, pancreatitis)6) Patients with total construction of artificial anus.7) Patients with gastrointestinal hemorrhage, perforation and history of mechanical ileus.8) Patients with serious complications (interstitial pneumonia, diabetes mellitus, heart failure, renal failure, hepatic insufficiency)9) Patients who are administered antiparkinson drug.10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy.11) Others, 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 1) Gastrointestinal symptom. (abdominal pain /distention/ the sensation of incomplete bowel evacuation)2) number of postoperative day to comfirm first evacuation, number of postoperative time to comfirm first flatus, number of bowel movements per day.
- Secondary Outcome Measures
Name Time Method 1) Pass Variance 2) QOL assessment using the GSRS questionnaire.3) number of white blood-cell and Neutrophilic, and CRP levels. 4) Abdominal radiography.5) Ileus and POI onset or not (a definition of ileus: The thing which the neighboring organizations adhere to intestinal tracts or an intestinal tract, and has higher than two items among intestinal tract stricture or an ileus state and abdomen symptoms. (abdominal pain,distention, nausea, vomiting) that it is, and may be related to a symptom of ileus).6) A dose / a rate of laxative