UMIN-CTR Clinical Trial

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
Email	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
Email	th.1984.06.01@gmail.com

Sponsor
Institute	Itabashi chuo medical center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025493