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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028443
Receipt No. 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

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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
Email 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
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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