UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057518 |
|---|---|
| Receipt number | R000065653 |
| Scientific Title | A cohort study for acute hemorrhagic rectal ulcer and ischemic colitis |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2025/04/04 16:02:40 |
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Basic information
Public title
A cohort study for acute hemorrhagic rectal ulcer and ischemic colitis
Acronym
A cohort study for acute hemorrhagic rectal ulcer and ischemic colitis
Scientific Title
A cohort study for acute hemorrhagic rectal ulcer and ischemic colitis
Scientific Title:Acronym
A cohort study for acute hemorrhagic rectal ulcer and ischemic colitis
Region
| Japan |
Condition
Condition
Acute hemorrhagic rectal ulcer, ischemic colitis
Classification by specialty
| Medicine in general | Gastroenterology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify mortality in patients with ischemic colitis or acute hemorrhagic rectal ulcer.
Basic objectives2
Others
Basic objectives -Others
To identify prognostic factors for acute hemorrhagic rectal ulcer and ischemic colitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality within 30 days of onset and in-hospital mortality
Key secondary outcomes
Factors associated with death, complications, transfusion volume, length of hospital stay
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients who presented acute hemorrhagic rectal ulcer or ischemic colitis at the participating facility during the study period
Key exclusion criteria
Outpatients and patients diagnosed with an inappropriate modality, or patients disagree with the consent form.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanno |
Organization
Jichi Medical University
Division name
Medical Education Center,
Zip code
3290498
Address
3311-1 Yakushiji, Shimono-shi, Tochigi, Japan
TEL
0285-44-2670
kanno.takeshi@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Saitsu |
Organization
Jichi Medical University
Division name
Medical Education Center
Zip code
3290498
Address
3311-1 Yakushiji, Shimono-shi, Tochigi, Japan
TEL
0285587067
Homepage URL
m07039as@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Takeshi Kanno
Funding Source
Organization
Jichi Medical University
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
Jichi Medical University
Address
3311-1 Yakushiji, Shimono-shi, Tochigi, Japan
Tel
0285-44-2111
rinri@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
自治医科大学病院（栃木県）、芳賀赤十字病院（栃木県）、日光市民病院（栃木県）、仙台医療センター（宮城県）、JCHO仙台病院（宮城県）、栗原中央病院（宮城県）、東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065653
