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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028007
Receipt No. 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

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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
Email 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
Email digestive@saitama-med.jrc.or.jp

Sponsor
Institute Saitama Red Cross Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031897

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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