UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016693 |
|---|---|
| Receipt number | R000018914 |
| Scientific Title | Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer |
| Date of disclosure of the study information | 2015/03/04 |
| Last modified on | 2020/03/03 19:52:10 |
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Basic information
Public title
Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer
Acronym
Comparison of coloninc cleansing methods
Scientific Title
Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer
Scientific Title:Acronym
Comparison of coloninc cleansing methods
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the safety and efficacy of two colonic cleansing methods (standard polyethylene glycol vs. low-volume polyethylene glycol).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
acceptability of colonic cleansing methods
Key secondary outcomes
frequency of bowel movement, dose of standard and low-volume polyethylene glycol, Time to first defecation, duration of taking medicine, Time to start examination
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who fills everything the
following
(1)Age of patients is above 20 years old
(2)Patients who were able to provide written informed consent for articipation in this study
Key exclusion criteria
(1) Patients who have or who are suspected to have gastrointestinal obstruction
(2) Patients who have or who are suspected to have gastrointestinal perforation
(3) Patients who have or who are suspected to have toxic megacolon
(4) Patients who have or who are suspected to have delayed gastric empty
(5) Patients who have glucose-6-phosphate dehydrogenase deficiency
(6) Patients who have renal dysfunction(blood urea nitrogen (BUN) >= 25 mg/dL, serum creatinine >= 2 mg/dL)
(7) Patients who have gastrointestinal stenosis
(8) Patients who have impaired vomiting reflex or risk of aspiration
(9) Patients who are dehydrated
(10) Patients who are under or need any treatments for severe cardiac disease (angina, cardiac infarction) or liver dysfunction (serum total bilirubin >= 3.0 mg/dL, ALT or AST >= 100 IU/L)
(11) Patients who have allergy of the drugs
(12) Patients who are pregnant or under lactation, or who would be expected to be pregnant during the study
(13) Patients who are not eligible due to physician's judgment
(14) Patients who are hospitalized for reasons other than taking colonoscopy
(15) Patients who receive intravenous hyperalimentation or enteral nutrition
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hasegawa |
Organization
Keio University School of Medicine
Division name
Departement of Surgery
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Okabayashi |
Organization
Keio University School of Medicine
Division name
Departement of Surgery
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
okabayashikoji@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO PHARMACEUTICALS CO.,LTD.
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018914
