UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022177 |
|---|---|
| Receipt number | 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 | 2021/05/06 12:12:08 |
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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 | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Department of Gastroentelorogy
Zip code
4801195
Address
1-1 yazako-karimata Nagakute-city Aichi prefecture
TEL
0561-62-3311
mebi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Department of Gastroentelorogy
Zip code
4801195
Address
1-1 yazako-karimata Nagakute-city Aichi prefecture Japan
TEL
0561-62-3311
Homepage URL
mebi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Institute
Department
Personal name
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
Aichi medical university
Address
1-1 Yazakokarimata, Nagakute
Tel
0561623311
mebi@aichi-med-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
| 2016 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
30
Results
finished
Results date posted
| 2021 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
bloody stool
Participant flow
informed consent
Adverse events
none
Outcome measures
the usefulness of strategy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025399
