UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045955 |
|---|---|
| Receipt number | R000052450 |
| Scientific Title | Natural history of hematochezia of unknown origin: Real-world analysis with long-term follow-up |
| Date of disclosure of the study information | 2021/11/06 |
| Last modified on | 2021/11/02 02:04:14 |
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Basic information
Public title
Natural history of Lower Gastrointestinal Bleeding of unknown origin
Acronym
Natural history of Lower Gastrointestinal Bleeding of unknown origin
Scientific Title
Natural history of hematochezia of unknown origin: Real-world analysis with long-term follow-up
Scientific Title:Acronym
Natural history of hematochezia of unknown origin: Real-world analysis with long-term follow-up
Region
| Japan |
Condition
Condition
hematochezia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
constructing proper management of hematochezia cases in which the bleeding source was not identified
Basic objectives2
Others
Basic objectives -Others
Case control study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rebleeding rate in hematochezia patients with an unidentified bleeding source
Key secondary outcomes
The period until rebleeding, total number of rebleeding episodes, the source of bleeding and the identification rate in rebleeding, the bleeding-related death rate, and rebleeding risk factors
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
Patients admitted to Dokkyo Medical University Hospital with the chief complaint of hematochezia
Key exclusion criteria
Exclusion criteria
1. those in whom hematochezia was not observed after the hospital visit
2. those who received endoscopic treatment within 1 month before the visit
3. those for whom observation up to the terminal ileum could not be done using colonoscopy
4. those for whom the cause of hematochezia was identified during the first colonoscopy
5. those who had no follow-up visit after hospital discharge (follow-up period 0 day)
6. those who had a past history of hematochezia
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University Hospital
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2147
irisawa@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takanao |
| Middle name | |
| Last name | Tanaka |
Organization
Dokkyo Medical University Hosipital
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2147
Homepage URL
tana1986@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
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
Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282-87-2147
tana1986@dokkyomed.ac.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
| 2021 | Year | 11 | Month | 06 | 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
159
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 | 02 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Study design:Case control study
Subject patients:
Patients admitted to Dokkyo Medical University Hospital during April 1, 2009-March 31, 2015 with the chief complaint of hematochezia
Factors investigated:
Age, sex, blood types, number of rebleeding episodes, colonoscopic findings (presence or absence of diverticula, tumor lesions, vascular lesions and anal diseases), hemoglobin on admission, platelet count on admission, use history of antithrombotic medicines during the observation period, use history of NSAIDs during the observation period, use history of prednisolone during the observation period, comorbidity (cardiovascular disease, liver disease, renal disease, cerebrovascular disease, diabetes, and hyperlipidemia), and death during the observation period
Management information
Registered date
| 2021 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052450
