UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054136 |
|---|---|
| Receipt number | R000061815 |
| Scientific Title | A study of the clinical course of different treatment for diverticular bleeding |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/12 16:24:57 |
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Basic information
Public title
A study of the clinical course of different treatment for diverticular bleeding
Acronym
A study of the clinical course of different treatment for diverticular bleeding
Scientific Title
A study of the clinical course of different treatment for diverticular bleeding
Scientific Title:Acronym
A study of the clinical course of different treatment for diverticular bleeding
Region
| Japan |
Condition
Condition
Colorectal diverticulum bleeding
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Review the course of colorectal diverticular bleeding by treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rebleeding rates by treatment modality
Key secondary outcomes
Procedural success rate, additional treatment, hospitalization course, and complications by treatment modality
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
Patients who diagnosed colorectal diverticular bleeding in our hospital
Key exclusion criteria
patients who refuses to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Sawada |
Organization
Hirosaki University Hospital
Division name
Department of Gastroenterology,Hematology and Immunology
Zip code
036-8562
Address
53 Hon-cho,Hirosaki
TEL
0172335111
sawada-y@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sawada |
Organization
Hirosaki University Hospital
Division name
Department of Gastroenterology,Hematology and Immunology
Zip code
036-8562
Address
53 Hon-cho,Hirosaki
TEL
0172335111
Homepage URL
sawada-y@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Yohei Sawada
Funding Source
Organization
Hirosaki University Hospital
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
Hirosaki University Hospital
Address
53 Hon-cho,Hirosaki
Tel
0172335111
sawada-y@hirosaki-u.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
| 2024 | Year | 04 | Month | 15 | 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
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
100 cases who diagnosed colorectal diverticular bleeding.
From electronic medical records, we collected medical information;patients chalactaristics,procedural success rat,additional treatment,course of hospitalization,trends in blood data,and post treatment course.
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061815
