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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001845
Receipt No. R000002136
Scientific Title Prospective validation of RCRI score for prediction of peri-operative complications in aged patients with major noncardiac surgery
Date of disclosure of the study information 2009/04/03
Last modified on 2018/08/24

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Basic information
Public title Prospective validation of RCRI score
for prediction of peri-operative complications
in aged patients with major noncardiac surgery
Acronym Prospective validation of RCRI score
for prediction of peri-operative complications
in aged patients with major noncardiac surgery
Scientific Title Prospective validation of RCRI score
for prediction of peri-operative complications
in aged patients with major noncardiac surgery
Scientific Title:Acronym Prospective validation of RCRI score
for prediction of peri-operative complications
in aged patients with major noncardiac surgery
Region
Japan

Condition
Condition major noncardiac surgery on aged patients
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Prospective validation of RCRI score
for prediction of peri-operative complications in aged patients with major noncardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes peri-operative complications
Key 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients were included in our database if they were 65 years of age or older and had undergone major noncardiac surgery. Having written informed consent.
Key exclusion criteria emergency operation
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Takeuchi
Organization School of Medicine, Keio University
Division name Department ofSufregry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Department ofSufregry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department ofSufregry, School of Medicine, Keio University
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 03 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
In the case of non-cardiac surgery, the RCRI
can identify patients at higher risk of perioperative complications,
a prolonged hospital stay and higher hospital cost.
Surg Today (2014) 44:277-284
DOI 10.1007/s00595-013-0543-3
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
2009 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information prospective study
outcome variable:
peri-operative complications
predictive variab;e:
RCRI score

Management information
Registered date
2009 Year 04 Month 03 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002136

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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