UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038013 |
|---|---|
| Receipt number | R000043330 |
| Scientific Title | Influence of meal on bowel preparation in colonoscopy:a pilot study |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2020/11/13 18:24:13 |
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Basic information
Public title
Influence of meal on bowel preparation in colonoscopy:a pilot study
Acronym
Influence of meal on bowel preparation in colonoscopy:a pilot study
Scientific Title
Influence of meal on bowel preparation in colonoscopy:a pilot study
Scientific Title:Acronym
Influence of meal on bowel preparation in colonoscopy:a pilot study
Region
| Japan |
Condition
Condition
Large intestine
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the outcome of lunch in colonoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma detection rate
Key secondary outcomes
Bowel preparation
Complication
Blood concentration
Polyp detection rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
control group (without lunch)
Interventions/Control_2
lunch group (with lunch)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients over 18 years old, who are admitted in our hospital
Key exclusion criteria
the following patients
-to plan examination or treatment
-with gastrectomy
-with past surgical history of colon
-with inflammatory bowel disease
-with cognitive impairment
-whose chief doctor judge that te patient does not fit this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | MASAMICHI |
| Middle name | |
| Last name | ARAO |
Organization
Takayama red cross hospital
Division name
Internal medicine
Zip code
5008367
Address
4-6-13
TEL
08049857465
aryao_poor_boy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Arao |
Organization
Takayama red cross hospital
Division name
Internal medicine
Zip code
5068550
Address
3-11, Tennmann cho, Takayama
TEL
0577-32-1111
Homepage URL
aryao_poor_boy@yahoo.co.jp
Sponsor or person
Institute
Takayama red cross hospital
Institute
Department
Personal name
Funding Source
Organization
Takayam red cross hospital
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
Takayama red cross hospital
Address
3-11, tennmann , takayama, gifu
Tel
0577321111
aryao_poor_boy@yahoo.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
| 2019 | Year | 09 | Month | 13 | 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
100
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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043330
