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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008348
Receipt No. 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

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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
Email 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
Email wakasugi@oph.gr.jp

Sponsor
Institute Osaka Police Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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