Colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder.
Conditions
Interventions
Oral administration of test drug (daikenchuto) 5.0 g per dose as a general rule (15 g/day, t.i.d., before meals) from patiant consent day to preoperative day and postoperative day 2 to postoperative d
Sponsors
Osaka Police Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, a patient must meet all of the following criteria.1) Patient who was judged that an colectomy was possible for treatment of the colon or rectal cancer.Preoperative staging of disease:I, II, IIIa, IIIbTNM category distribution: T=1-3, N=0-2, M=02) Patients with PS (ECOG Performance Status Scale):0, 13) Patients who are diagnosed as pre-operative constipation CTCAE ver.4 grade is at least 1 and abdominal pain and/or distention GSRS score at least 3.4) Age: 20 years or older5) Gender: no specification6) Inpatient/Outpatient: Inpatient7) Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasaki Wakasugi
Osaka Police Hospital Surgery
Outcome results
None listed