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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002832
Receipt No. 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

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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
Email

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
Email nnagata_ncgm@yahoo.co.jp

Sponsor
Institute International Medical Center of Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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