UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002832 |
|---|---|
| Receipt number | R000003362 |
| Scientific Title | The Effectiveness of Therapeutic Barium Enema for Prevention of Colonic Diverticular Rebleeding - Randomized Control study |
| Date of disclosure of the study information | 2009/12/02 |
| Last modified on | 2013/06/11 17:30:55 |
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Basic information
Public title
The Effectiveness of Therapeutic Barium Enema for Prevention of Colonic Diverticular Rebleeding - Randomized Control study
Acronym
The Effectiveness of Therapeutic Barium Enema for Prevention of Colonic Diverticular Rebleeding - Randomized Control Study
Scientific Title
The Effectiveness of Therapeutic Barium Enema for Prevention of Colonic Diverticular Rebleeding - Randomized Control study
Scientific Title:Acronym
The Effectiveness of Therapeutic Barium Enema for Prevention of Colonic Diverticular Rebleeding - Randomized Control Study
Region
| Japan |
Condition
Condition
colonic diverticular bleeding
Classification by specialty
| Medicine in general | Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of barium therapy when compared with conservative therapy for colonic diverticular bleeding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The rate and period until diverticular rebleeding after the treatment with barium and conservative therapy
Key secondary outcomes
clinical data between rebleeding and non-rebleeding patients: age, sex, underlying disease, history of medication, and volume of transfusion.
clical data on barium therapy: the finding of X-ray, examination time, and complication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Barium therapy(intervention)
Period of study for the enrolled: 12 months
Follow-up: 12months
Total period: 24 months
Amount and concentration: 400ml, 200w/v%
Number of times: one
Interventions/Control_2
Conseravative therapy(control)
Period of study for the enrolled: 12 months
Follow-up: 12months
Total period: 24 months
Contents of therapy: dietary restriction and intravenous infusion
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient informations are as follows
1.nationality: Japanese
2.inpatient
3.Patients with independence in activities of daily living
4.Patients with painless hematochezia in abdomen
5.patients who was diagnosed with colonic diverticular bleeding from imaging test including CT or endoscopy
6.Patients with success of initial therapy (hemostasis) in colonic diverticular bleeding
Key exclusion criteria
Patient informations are as follows
1.Patients who does not provide consent
2.Patients who was diagnosed with other intestinal bleeding such as colon cancer, hemorroids with bleeding, upper gastrointestinal bleeding, and small-bowel bleeding
3.Patients with little improvement of hemostasis by initial therapy
4.Patients with hemorrhagic shock or with suspected hemorrhagic shock
5.Patients with allergic reaction to contrast dye incuding CT and barium examination
6.Patients with suspected intestinal obstruction on the X-ray
7.Patients with a history of barium therapy within 6 months
8.Patients with terminal cancer
9.Patients with difficulty in changing body position
10.Patients with suspected pregnancy
11.Patients with a history of colon resection
12.Patients with already revealed intestinal cancer
13.Patients with diagnosis of imflammatory bowel disease(IBD)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Uemura |
Organization
International Medical Center of Japan
Division name
Gastroenterology
Zip code
Address
1-21-1 Toyama Shinjyuku-ku Tokyo Japan
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyoshi Nagata |
Organization
International Medical Center of Japan
Division name
Gastroenterology
Zip code
Address
1-21-1 Toyama Shinjyuku-ku Tokyo Japan
TEL
03-3202-7181
Homepage URL
nnagata_ncgm@yahoo.co.jp
Sponsor or person
Institute
International Medical Center of Japan
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
| 2009 | Year | 12 | Month | 02 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 01 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 02 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003362
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