UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001845 |
|---|---|
| Receipt number | 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 09:48:41 |
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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
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
Sponsor or person
Institute
Department ofSufregry, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002136
