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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021869
Receipt No. 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

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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 To怀clear 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
Email 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
Email hiromailtokyo@yahoo.co.jp

Sponsor
Institute Japan society for surgical infection
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025026

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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