UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037658 |
|---|---|
| Receipt number | R000042944 |
| Scientific Title | Comparison and examination of standard method and two cup one cup method of oral enteral lavage in colonoscopy |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2019/08/10 15:00:01 |
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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
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
cnic-kato@aoyama-hp.or.jp
Sponsor or person
Institute
Aoyama General Hospital
Nursing department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042944
