UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021869 |
|---|---|
| Receipt number | R000025026 |
| Scientific Title | Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/04/11 17:51:39 |
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Basic information
Public title
Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital
Acronym
Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital
Scientific Title
Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital
Scientific Title:Acronym
Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital
Region
| Japan |
Condition
Condition
post-operated Remote Infection (pneumonia,urinary truct infection, intravascular catheter related infection, enteritis associated with antibiotics )
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Toćclear medical expenses beared, assosiated with PRI.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
surgical code of 2014(K-code),operation name, PRI(+,-), SSI(+,-),age at operation, ASA score, place of PRI and SSI, isolated bacterium of PRI, number of day after operation, medical expenses after operationa(total, itemized)
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
| 16 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the targets are patients who underwent the surgery since October 1st 2013 until september 3rd 2015, and discharged, transfferred hospital or dead.The studied surgery are 27 K-code of medical remuneration table of 2014.
case and clntrol are adapted one to one.
case is the patient with PRI. The attending physician or doctor who reported diagnosed the PRI based on NIHS guideline of CDC.
control is the patient without PRI. surgery was performed same hospital as case patient. same K-code, of the same sex, age minus 5 year to plus 5 year of case patient, without treated history by steroid,operated day is closest to operated day of the case. Duplication is permitted for control patient.
Key exclusion criteria
ASA score is equal or over 3
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kusachi |
Organization
Japan society for surgical infection/ toho university medical center ohashi hospital
Division name
department of surgery
Zip code
Address
2-17-6, ohashi, meguro-ku, tokyo, japan
TEL
03-3468-1251
kusachi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Nishimuta |
Organization
toho university medical center ohashi hospital
Division name
department of surgery
Zip code
Address
2-17-6, ohashi, meguro-ku, tokyo, japan
TEL
03-3468-1251
Homepage URL
hiromailtokyo@yahoo.co.jp
Sponsor or person
Institute
Japan society for surgical infection
Institute
Department
Personal name
Funding Source
Organization
Japan society for surgical infection
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
| 2016 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
surgical code of 2014(K-code),operation name, PRI(+,-), SSI(+,-),age at operation, ASA score, place of PRI and SSI, isolated bacterium of PRI, number of day after operation, medical expenses after operationa(total, itemized)
Management information
Registered date
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025026
