UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040508 |
|---|---|
| Receipt number | R000046243 |
| Scientific Title | Survey on bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2021/04/13 13:08:15 |
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Basic information
Public title
Survey on bowel preparation for colonoscopy
Acronym
Survey on bowel preparation for colonoscopy
Scientific Title
Survey on bowel preparation for colonoscopy
Scientific Title:Acronym
Survey on bowel preparation for colonoscopy
Region
| Japan |
Condition
Condition
Patients scheduled for colonoscopy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain evidence for a bowel preparation agent that meets the needs of our customers, in order to clarify what is important in pretreatment of colonoscopy for medical professionals (physicians, nurses, technicians) by questionnaire surveys on the Web.
Basic objectives2
Others
Basic objectives -Others
Fact-finding survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Importance scores of bowel preparation for colonoscopy by items.
Key secondary outcomes
Differences between occupations (physicians/nurses/technicians) on the importance score of bowel preparation for colonoscopy by item.
Differences by facility and respondent background on the importance score of bowel preparation for colonoscopy by item.
Aggregation of confirmation items before inspection.
Aggregation of defecation management before inspection.
Aggregation of evaluation of bowel preparation in use.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Physicians, nurses, and technicians performing colonoscopies
- Currently working at a facility that performs more than 20 colonoscopies per month
Key exclusion criteria
No specific settings
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Masaki |
Organization
EA Pharma Co., Ltd.
Division name
Associate General Manager (Medical Department)
Zip code
104-0042
Address
2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
03-6280-9685
hisanori_masaki@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Masaki |
Organization
EA Pharma Co., Ltd.
Division name
Associate General Manager (Medical Department)
Zip code
104-0042
Address
2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
03-6280-9685
Homepage URL
hisanori_masaki@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma 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
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.co.jp
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
| 2020 | Year | 06 | Month | 01 | 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
330
Results
All medical doctors and approximately 90% of nurses and technicians understood the risk of using a lavage solution. Interviews using patient information were conducted in almost 100% of either occupation. However, the answer that a corresponding manual had been created varied among occupations. In particular, 40% of medical doctors and 20% of nurses and technicians answered that they have no corresponding manual for patients who were taking lavage solution at home.
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046243
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
