UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of the length of stay and the medical expenditure of post-operative remote infection in Japanese hospital
Title of the study (Brief title)	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　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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinya Kusachi
Organization	Japan society for surgical infection/ toho university medical center ohashi hospital
Division name	department of surgery
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	Hironobu Nishimuta
Organization	toho university medical center ohashi hospital
Division name	department of surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025026