UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026797 |
|---|---|
| Receipt number | R000030759 |
| Scientific Title | Effectiveness of simethicone to improve bowel cleansing and adenoma detection rate in colonoscopy |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/03/31 09:56:16 |
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Basic information
Public title
Effectiveness of simethicone to improve bowel
cleansing and adenoma detection rate in
colonoscopy
Acronym
Effectiveness of simethicone to improve bowel
cleansing and adenoma detection rate in
colonoscopy
Scientific Title
Effectiveness of simethicone to improve bowel
cleansing and adenoma detection rate in
colonoscopy
Scientific Title:Acronym
Effectiveness of simethicone to improve bowel
cleansing and adenoma detection rate in
colonoscopy
Region
| Asia(except Japan) |
Condition
Condition
Bowel preperation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve bowel cleansing using bowel
cleansing agents with simethicone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of colon cleanness and grade of bubble using simethicone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: simethicone group
Interventions/Control_2
Control: No simethicone group
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) diagnostic work up of colonic symptoms
(2) surveillance of colorectal polyp
(3) colorectal cancer screening
Key exclusion criteria
(1)Familial colorectal cancer syndrome
(FAP or HNP)
(2)Personal history of colorectal cancer or
IBD
(3)Previous colonic resection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kim Hae Won |
Organization
Soonchunhyang University School of Medicine,
Bucheon Hospital
Division name
Gastroenterology
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon City, Gyenggi-do
TEL
82326215114
oriya01@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ko Bongmin |
Organization
Soonchunhyang University School of Medicine, Bucheon Hospital
Division name
Gastroenterology
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon City, Gyenggi-do
TEL
82326215114
Homepage URL
oriya01@schmc.ac.kr
Sponsor or person
Institute
Soonchunhyang University School of Medicine, Bucheon Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030759
