UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048940 |
|---|---|
| Receipt number | R000042594 |
| Scientific Title | Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage |
| Date of disclosure of the study information | 2022/09/16 |
| Last modified on | 2022/09/15 01:42:16 |
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Basic information
Public title
Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Acronym
Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Scientific Title
Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Scientific Title:Acronym
Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Region
| Japan |
Condition
Condition
Diverticular hemorrhage
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can we establish an efficient and safe emergency endoscopic care system using a scoring system (JD score) created based on past cases at our hospital?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in bleeding source identification rate by scoring
Key secondary outcomes
Period of admission, volume of blood transfusion, rebleeding rate, harmful events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Emergency endoscopy
Interventions/Control_2
No Emergency endoscopy
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
Patients with clinically suspected colonic diverticular hemorrhage after exclusion of other diseases based on clinical course, physical examination, and contrast-enhanced CT findings
Key exclusion criteria
1) Patients under 20 years of age who could not give consent, including a surrogate; 2) Patients who had a bloody episode within 30 days prior to the visit; 3) Patients with suspected bleeding other than diverticular hemorrhage; 4) Patients who deviated from the protocol.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | UEHARA |
Organization
saitama medical center jichi medical univ
Division name
Gastroenterology
Zip code
330-8503
Address
1-847 amanuma oomiya saitama
TEL
048-647-2111
t.uehara@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | UEHARA |
Organization
saitama medical center jichi medical univ
Division name
Gastroenterology
Zip code
330-8503
Address
1-847 amanuma oomiya saitama
TEL
048-647-2111
Homepage URL
t.uehara@jichi.ac.jp
Sponsor or person
Institute
saitama medical center jichi medical univ
Institute
Department
Personal name
Funding Source
Organization
saitama medical center jichi medical univ
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
saitama medical center jichi medical univ
Address
1-847 amanuma oomiya saitama
Tel
048-647-2111
t.uehara@jichi.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
自治医科大学附属さいたま医療センター 埼玉県
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 16 | 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
91
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042594
| 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 |
