UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010652 |
|---|---|
| Receipt number | R000012409 |
| Scientific Title | Evaluation of efficacy of hood assisted colonoscopy in trainees |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2020/05/21 13:06:03 |
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Basic information
Public title
Evaluation of efficacy of hood assisted colonoscopy in trainees
Acronym
Evaluation of efficacy of hood assisted colonoscopy in trainees
Scientific Title
Evaluation of efficacy of hood assisted colonoscopy in trainees
Scientific Title:Acronym
Evaluation of efficacy of hood assisted colonoscopy in trainees
Region
| Japan |
Condition
Condition
whole field of colon disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of hood for total colonoscopy in trainees
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between hood assited colonoscopy and cecal intubation rate
Key secondary outcomes
The relationship between hood assited colonoscopy and cecal intubation time
The relationship between hood assited colonoscopy and patient discomfort
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
attach hood
Interventions/Control_2
not attach hood
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who need colonoscopy
Key exclusion criteria
emergent colonoscopy
colonic obstruction
gastrointestinal bleeding
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Takemoto |
Organization
Tsuyama Chuo Hospital
Division name
Gastrointestinal Endoscopy Center
Zip code
708-0841
Address
1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL
0868-21-8111
soichiro.ako@gmail.com
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Ako |
Organization
Tsuyama Chuo Hospital
Division name
Gastrointestinal Endoscopy Center
Zip code
708-0841
Address
1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL
0868-21-8111
Homepage URL
soichiro.ako@gmail.com
Sponsor or person
Institute
Tsuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuyama Chuo 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
Tsuyama Chuo Hospital
Address
1756 Kawasaki Tsuyama City Okayama Prefecture Japan
Tel
0868-21-8111
soichiro.ako@gmail.com
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
津山中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 06 | Day |
Last modified on
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012409
