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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040508
Receipt No. 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

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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
Email 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
Email hisanori_masaki@eapharma.co.jp

Sponsor
Institute EA Pharma Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046243

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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