UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028443 |
|---|---|
| Receipt number | R000032560 |
| Scientific Title | Analysis of relation between obscure gastrointestinal bleeding (OGIB) and vital prognosis a retrospective cohort study |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2019/01/29 14:36:52 |
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Basic information
Public title
Analysis of relation between obscure gastrointestinal bleeding (OGIB) and vital prognosis a retrospective cohort study
Acronym
OGIB a retrospective cohort study
Scientific Title
Analysis of relation between obscure gastrointestinal bleeding (OGIB) and vital prognosis a retrospective cohort study
Scientific Title:Acronym
OGIB a retrospective cohort study
Region
| Japan |
Condition
Condition
OGIB
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of signs in capsule endoscopy for OGIB on the prognosis.
Basic objectives2
Others
Basic objectives -Others
The effect of signs in capsule endoscopy for OGIB on the prognosis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
life expectancy
Key secondary outcomes
The effect of clinical background on life expectancy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
OGIB
Key exclusion criteria
Obvious bleeding in the gut revealed by GS or CS
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Japan
TEL
043-226-2083
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30636251
Number of participants that the trial has enrolled
Results
We clarified the prognosis of OGIB patients.
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
| 2017 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
analysis for the prognosis of OGIB patients who underwent capsule endoscopy in Chiba University Hospital by retrospective cohort method.
Management information
Registered date
| 2017 | Year | 07 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
