UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027450 |
|---|---|
| Receipt number | R000031447 |
| Scientific Title | Single center retrospective observational study for management of upper gastrointestinal bleeding between by emergency physician with endoscopy training and gastroenterologist or general surgeon |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2018/06/07 12:35:51 |
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Basic information
Public title
Single center retrospective observational study for management of upper gastrointestinal bleeding between by emergency physician with endoscopy training and gastroenterologist or general surgeon
Acronym
Retrospective study for management of upper gastrointestinal bleeding by emergency physician
Scientific Title
Single center retrospective observational study for management of upper gastrointestinal bleeding between by emergency physician with endoscopy training and gastroenterologist or general surgeon
Scientific Title:Acronym
Retrospective study for management of upper gastrointestinal bleeding by emergency physician
Region
| Japan |
Condition
Condition
gastrointestinal bleeding
Classification by specialty
| Gastroenterology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical outcomes and safety of gastrointestinal bleeding cases between treated by an emergency physician (EP) and by gastroenterologist or general surgeon
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality
Key secondary outcomes
Transfusion, rebleeding and adverse events, and length of hospital stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Upper GI bleeding cases treated using endoscopy in the emergency department between 2012 and 2014
Key exclusion criteria
Patients transferred from other hospitals, or had GI bleeding during the hospital stay due to non-GI causes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kobe |
Organization
Kuki General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
418-1, Kamihayami, Kuki, Saitama
TEL
81480260033
y-kobe@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Kobayashi |
Organization
Shin-Kuki General Hospital
Division name
General Administration Department
Zip code
Address
418-1, Kamihayami, Kuki, Saitama
TEL
81480260033
Homepage URL
y-kobayashi@shinkuki-hp.jp
Sponsor or person
Institute
Kuki General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kuki General Hospital
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 | 05 | Month | 22 | 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
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
A retrospective chart review was conducted on all patients admitted to the emergency department of the Kuki General Hospital between April 2012 and March 2014.
Management information
Registered date
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031447
