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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006486
Receipt No. R000007696
Scientific Title Evaluation of Calculation of postOperative Risk in Emergency Surgery(CORES) in emergency operations: A multicenter cohort study
Date of disclosure of the study information 2011/10/13
Last modified on 2014/02/11

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Basic information
Public title Evaluation of Calculation of postOperative Risk in Emergency Surgery(CORES) in emergency operations: A multicenter cohort study
Acronym CORES study
Scientific Title Evaluation of Calculation of postOperative Risk in Emergency Surgery(CORES) in emergency operations: A multicenter cohort study
Scientific Title:Acronym CORES study
Region
Japan

Condition
Condition Patients undergoing any type of emergency operations in any departments
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Ophthalmology
Dermatology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Operative medicine Emergency medicine Intensive care medicine
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Postoperative mortality rates following emergency operations are generally poorer than those in elective operations. Nevertheless,there has been no model reported to predict those rates in emergency operations. We have constructed a specific model to predict postoperative mortality rates which can be applied to a wide variety of surgery by analyzing previously operated patients. We designated this model as Calculation of postOperative Risk in Emergency Operations (CORES). CORES requires only 5 variables. This study was designed to validate the accuracy of CORES in a multicenter fashion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In-hospital mortality
Key secondary outcomes Postoperative complications

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing any kind of emergency surgical procedures within 24 hours of initial presentation
Key exclusion criteria None
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miyazaki
Organization National Hospital Organization Kumamoto Medical Center
Division name anesthesiology
Zip code
Address 1-5 Ninomaru, Kumamoto 8600008, JAPAN
TEL 81-96-353-6501
Email motomiyazaki@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Haga
Organization National Hospital Organization Kumamoto Medical Center
Division name Institute for clinical research
Zip code
Address 1-5 Ninomaru, Kumamoto 8600008, JAPAN
TEL 81-96-353-6501
Homepage URL
Email yoshio@kumamoto.hosp.go.jp

Sponsor
Institute National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

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 国立病院機構熊本医療センター(熊本県)、済生会熊本病院(熊本県)、熊本赤十字病院(熊本県)、熊本労災病院(熊本県)、八代総合病院(熊本県)、水俣市立総合医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results CORES exhibited a high AUC value (0.85: 0.81-0.89) and a significant correlation with postoperative morbidity.
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
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information before start

Management information
Registered date
2011 Year 10 Month 05 Day
Last modified on
2014 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007696

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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