UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049020 |
|---|---|
| Receipt number | R000055826 |
| Scientific Title | Survey of Colonic Diverticular Bleeding |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/09/27 17:38:21 |
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Basic information
Public title
Survey of the Treatment of Patients with Colonic Diverticular Bleeding; A multicenter retrospective observational study
Acronym
Survey of Colonic Diverticular Bleeding
Scientific Title
Survey of Colonic Diverticular Bleeding
Scientific Title:Acronym
Survey of Colonic Diverticular Bleeding
Region
| Japan |
Condition
Condition
Colonic Diverticular Bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the number of cases of diverticular bleeding in the past year at the collaborating institutions and the rate of rebleeding.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of rebleeding within 30 days in patients without SRH and without endoscopic hemostasis
Key secondary outcomes
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) All patients who had bloody stools between January 1, 2019 and December 31, 2019, and a colonoscopy was performed within 48 hours of the visit to diagnose colonic diverticular bleeding.
(2) Patients between the ages of 20 and 85 years.
Key exclusion criteria
(1) Patients with a history of colorectal resection
(2) Patients who have expressed their refusal to participate in this study
(3) Other patients who are deemed inappropriate to participate in this study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kinjyo |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
kenkinjo@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hisabe |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
Homepage URL
hisabe@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
7-45-1 nanakuma, Jyonanku, Fukuoka 814-0180
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2022 | Year | 09 | Month | 26 | 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
125
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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Percentage of rebleeding within 30 days in patients without SRH and without endoscopic hemostasis.
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/10/07 | 221007UMIN登録_憩室出血既存資料データ.xlsx |
