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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name