UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022307 |
|---|---|
| Receipt number | R000025493 |
| Scientific Title | Create and validation of scoring system for mortality in intestinal perforations |
| Date of disclosure of the study information | 2016/05/13 |
| Last modified on | 2021/11/16 11:36:49 |
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Basic information
Public title
Create and validation of scoring system for mortality in intestinal perforations
Acronym
Prognostic factors of emergency room for mortality in intestinal perforations
Scientific Title
Create and validation of scoring system for mortality in intestinal perforations
Scientific Title:Acronym
Prognostic factors of emergency room for mortality in intestinal perforations
Region
| Japan |
Condition
Condition
intestinal perforation
Classification by specialty
| Gastrointestinal surgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intestinal perforation is a major life-threatening condition associated with high morbidity and mortality.
Many studies reported prognostic factor and scoring system for mortality in intestinal perforation, however there are few study about prognostic factor of emergency room for mortality this disease.
The aim of this retrospective study is assess the prognostic value of several factors of emergency room for mortality intestinal perforation
We will validate new scoring using for another hospital dataset
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality after hospital admission
Key secondary outcomes
there are no secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with intestinal perforation
Key exclusion criteria
Non
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Hijikata |
Organization
Itabashi Chuo medical center
Division name
Emergency Departoment
Zip code
174-0051
Address
Azusawa Itabashi Tokyo Japan
TEL
03-3967-1181
th.1984.06.01@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Hijikata |
Organization
Itabashi chuo medical center
Division name
Emergency Department
Zip code
174-0051
Address
2-12-7 Azusawa Itabashi, Tokyo, Japan
TEL
03-3967-1181
Homepage URL
th.1984.06.01@gmail.com
Sponsor or person
Institute
Itabashi chuo medical center
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinmatudo Central General Hospital
Center Hospital of the National center for global Health and Medicine
Self-Defense Forces Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itabashi chuo medical center
Address
2-12-7 Azusawa Itabashi, Tokyo, Japan
Tel
03-3967-1181
th.1984.06.01@gmail.com
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
板橋中央総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 13 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
cohort study
Management information
Registered date
| 2016 | Year | 05 | Month | 13 | Day |
Last modified on
| 2021 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025493
