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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022177
Receipt No. R000025399
Scientific Title The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Date of disclosure of the study information 2016/05/09
Last modified on 2016/05/09

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Basic information
Public title The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Acronym The efficacy of the new strategy for the patients with diverticula and hematochezia.
Scientific Title The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Scientific Title:Acronym The efficacy of the new strategy for the patients with diverticula and hematochezia.
Region
Japan

Condition
Condition colonic diverticula
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Multicenter prospective study of the efficacy of the treatment strategy for the patients with colonic diverticula and hematochezia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of re-bleeding in the hospital
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 the group of urgent colonoscopy. If bleeding point is detected, endoscopic hemostasis is performed. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.
Interventions/Control_2 the group of conservative treatment. Without urgent colonoscopy, the patient is treated by intravenous hemostatic agent. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.
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 The patients with colonic diverticula by abdominal enhanced CT or colonoscopy, without extravazation.
The patients with hematochezia.
The patients who agreed to this study.
Key exclusion criteria The patients with extravasation in abdominal enhanced CT.
The patients who were suspected the other disease, for example ischemic colitis and colorectal cancer
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Ebi
Organization Aichi medical university
Division name Department of Gastroentelorogy
Zip code
Address 1-1 yazako-karimata Nagakute-city Aichi prefecture
TEL 0561-62-3311
Email mebi@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahide Ebi
Organization Aichi medical university
Division name Department of Gastroentelorogy
Zip code
Address 1-1 yazako-karimata Nagakute-city Aichi prefecture Japan
TEL 0561-62-3311
Homepage URL
Email mebi@aichi-med-u.ac.jp

Sponsor
Institute Aichi medical university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kasugai municipal hospital
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
2016 Year 05 Month 09 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
2016 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025399

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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