UMIN-CTR Clinical Trial

Basic information
Public title	Comparison and examination of standard method and two cup one cup method of oral enteral lavage in colonoscopy
Acronym	Comparison and examination of standard method and two cup one cup method of oral enteral lavage in colonoscopy
Scientific Title	Comparison and examination of standard method and two cup one cup method of oral enteral lavage in colonoscopy
Scientific Title:Acronym	Comparison and examination of standard method and two cup one cup method of oral enteral lavage in colonoscopy
Region	Japan

Condition
Condition	Gastroenterology outpatients undergoing colonoscopy
Classification by specialty	Gastroenterology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will compare and consider the taking method (standard method and two cups method) so that patients can take oral intestinal cleanser used for pretreatment of colonoscopy without pain.
Basic objectives2	Others
Basic objectives -Others	By comparing and examining how to take the oral intestinal cleanser used in colonoscopy, it becomes a pretreatment that can alleviate the pain and anxiety of the patient.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ease of drinking Movi prep (taste, amount, water consumption) Comprehension of how to medication
Key secondary outcomes	Cleaning effect evaluation Mobiprep dose Water consumption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Standard method for oral intestinal cleanser
Interventions/Control_2	two cup one cup methodfor oral intestinal cleanser
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	Gastroenterological outpatients undergoing colonoscopy and patients with consent
Key exclusion criteria	Person who can not obtain consent
Target sample size	480

Research contact person
Name of lead principal investigator	1st name Yoshiko Middle name Last name Hayashi
Organization	Aoyama General Hospital
Division name	Outpatient
Zip code	441-0195
Address	100-1, Doji Kozakai, Toyokawa, Aichi,Japan
TEL	+81-533-73-3777
Email	gairai@aoyama-hp.or.jp

Public contact
Name of contact person	1st name Mayumi Middle name Last name Kato
Organization	Aoyama General Hospital
Division name	Outpatient
Zip code	441-0195
Address	100-1, Doji Kozakai, Toyokawa, Aichi,Japan
TEL	+81-533-73-3777
Homepage URL
Email	cnic-kato@aoyama-hp.or.jp

Sponsor
Institute	Aoyama General Hospital Nursing department
Institute
Department

Funding Source
Organization	Aoyama General Hospital Nursing department
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aoyama General Hospital Ethics Committee
Address	100-1, Doji Kozakai, Toyokawa, Aichi,Japan
Tel	+81-533-73-3777
Email	ijika@aoyama-hp.or.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	総合青山病院（愛知県） Aoyama General Hospital （Aichi）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 22 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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 08 Month 10 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2020 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 10 Day
Last modified on	2019 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042944