UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008348 |
|---|---|
| Receipt number | R000009820 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2012/07/04 |
| Last modified on | 2020/07/10 09:36:59 |
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Basic information
Public title
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.
Acronym
Clinical effectiveness of daikenchuto (TJ-100) on abdominal pain and distention after cancer resection in the colorectal cancer patients.
Scientific Title
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.
Scientific Title:Acronym
Clinical effectiveness of daikenchuto (TJ-100) on abdominal pain and distention after cancer resection in the colorectal cancer patients.
Region
| Japan |
Condition
Condition
Colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose in this study is to examine a clinical effectiveness of daikenchuto on the gastrointstinal dysfunction-related symptom, such as abdominal pain and distention, and QOL after colectomy in the colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder (prolonged POI high risk patients).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 day 28.
Interventions/Control_2
Standard of care.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Akamatsu |
Organization
Osaka Police Hospital
Division name
Surgery
Zip code
543-0035
Address
10-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan
TEL
06-6771-6051
wakasugi@oph.gr.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Wakasugi |
Organization
Osaka Police Hospital
Division name
Surgery
Zip code
543-0035
Address
0-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan
TEL
06-6771-6051
Homepage URL
wakasugi@oph.gr.jp
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Police Hospital
Address
10-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan
Tel
06-6771-6051
wakasugimasaki@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪警察病院(大阪)／Osaka Police Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
pubmed.ncbi.nlm.nih.gov/32588153/
Publication of results
Published
Result
URL related to results and publications
pubmed.ncbi.nlm.nih.gov/32588153/
Number of participants that the trial has enrolled
32
Results
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.
Results date posted
| 2020 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing colorectal surgery at the Osaka Police Hospital
Participant flow
The patients were randomly assigned to either the DKT group or the control group.
Adverse events
None
Outcome measures
Primary endpoints were i) gastrointestinal symptoms (abdominal pain/distention) measured by the Visual Analogue Scale (VAS); ii) the sensation of incomplete bowel evacuation (yes/no); and iii) POD to confirm first evacuation, postoperative time to confirm first flatus, and the number of bowel movements per day. Secondary endpoints included quality of life (QOL) (acid reflux, abdominal pain, indigestion, diarrhea, and constipation) assessment using the GSRS questionnaire. Participants completed the questionnaire on the day of informed consent before the operation (about 2 weeks before surgery) and on PODs 3, 7, 14, 21, and 28.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009820
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