UMIN-CTR Clinical Trial

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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