UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028007 |
|---|---|
| Receipt number | R000031897 |
| Scientific Title | Validity of conservative treatment without urgent endoscopy for colonic diverticular hemorrhage |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2017/06/29 18:19:25 |
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Basic information
Public title
Validity of conservative treatment without urgent endoscopy for colonic diverticular hemorrhage
Acronym
Validity of conservative treatment for colonic diverticular hemorrhage
Scientific Title
Validity of conservative treatment without urgent endoscopy for colonic diverticular hemorrhage
Scientific Title:Acronym
Validity of conservative treatment for colonic diverticular hemorrhage
Region
| Japan |
Condition
Condition
colonic diverticular hemorrhage
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the validity of conservative treatment for non-severe colonic diverticular hemorrhage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of spontaneous hemostasis by conservative treatment for colonic diverticular hemorrhage
Key secondary outcomes
1. Clinical backgrounds of patients requiring urgent endoscopy/IVR
2. Rate of rebleeding after conservative treatment
3. Factors related with rebleeding after conservative treatment
4. Comparison of hospitalization costs between conservative treatment and urgent endoscopy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In case of controlled hemorrhagic shock, conservative treatment with fasting and fluid administration would be performed, in spite of existence of extravasation with enhanced CT.
Interventions/Control_2
For patients with shock and extravasation on enhanced CT, urgent endoscopy would be performed. However, in case of uncontrolled hemorrhagic shock after initial treatment with fluid resuscitation, interventional radiology would be considered for hemostasis.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Emergency outpatient who required hospital admission for the treatment of frequent hematochezia.
2)Patients with a diagnoses of colonic diverticulum by lower gastrointestinal endoscopy or abdominal CT.
3)Other possible sources of gastrointestinal bleeding were ruled out by upper and lower gastrointestinal endoscopy and abdominal CT.
4)Patients who provided written informed consents for this study by themselves.
Key exclusion criteria
1)Other possible sources of gastrointestinal bleeding was found by endoscopic examination.
2)Colonoscopy was not performed within 2 weeks after admission.
3)Patient who was judged as inappropriate for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Sasajima |
Organization
Saitama Red Cross Hospital
Division name
Digestive internal medicine
Zip code
Address
1-5 Shintoshin, Chuo-ku, Saitama-city, Saitama pref, 330-8853 Japan
TEL
048-852-1111
digestive@saitama-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirosato Doi |
Organization
Saitama Red Cross Hospital
Division name
Digestive internal medicine
Zip code
Address
1-5 Shintoshin, Chuo-ku, Saitama-city, Saitama pref, 330-8853 Japan
TEL
048-852-1111
Homepage URL
digestive@saitama-med.jrc.or.jp
Sponsor or person
Institute
Saitama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 06 | Month | 30 | 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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | 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
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031897
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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