UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004533 |
|---|---|
| Receipt number | R000003363 |
| Scientific Title | The risk factors for colonic diverticular bleeding |
| Date of disclosure of the study information | 2010/11/10 |
| Last modified on | 2012/11/11 23:11:09 |
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Basic information
Public title
The risk factors for colonic diverticular bleeding
Acronym
The risk factors for colonic diverticular bleeding
Scientific Title
The risk factors for colonic diverticular bleeding
Scientific Title:Acronym
The risk factors for colonic diverticular bleeding
Region
| Japan |
Condition
Condition
Colonic diverticular diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors for diverticular bleeding
Basic objectives2
Others
Basic objectives -Others
Risk factors
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Independent risk factors for bleeding in patients with colonic diverticular diseases
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are as follows
1.Nationality:Japanese
2.Patients who were diagnosed colonic diverticulum with endoscopy
3.Patients with painless hematochezia in abdomen and diagnosed colonic diverticular bleeding with endoscopy
Key exclusion criteria
Exclusion criteria are as follows
1.Patients who did not provide consent
2.Patients who were diagnosed with other intestinal bleeding such as colon cancer, hemorroids with bleeding, angioectasia, upper gastrointestinal bleeding, and small-bowel bleeding
3.Patients with allergic reaction to contrast dye including CT
4.Patients with already revealed intestinal cancer
5.Patients with diagnosis of inflammatory bowel disease(IBD)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Uemura |
Organization
National Center for Global Health and Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-21-1 Toyama Shinjuku-ku Tokyo Japan
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyoshi Nagata |
Organization
National Center for Global Health and Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-21-1 Toyama Shinjuku-ku Tokyo Japan
TEL
03-3202-7181
Homepage URL
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2010 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22354135
Number of participants that the trial has enrolled
Results
Results: A total of 254 patients(diverticular bleeding, 45;diverculosis, 209) were selected for analysis. Cluster (≥10 diverticula) type (OR, 4.0; 95% CI, 1.8–8.9), hypertension(OR, 2.2; 95% CI, 1.0–4.6), ischemic heart disease (OR, 2.4; 95% CI, 1.1–5.4), and chronic renal failure (OR, 6.4; 95% CI,1.3-32) were independent risk factors for diverticular bleeding.
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Prospective study
Case control study
Management information
Registered date
| 2010 | Year | 11 | Month | 10 | Day |
Last modified on
| 2012 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003363
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
