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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002813
Receipt No. R000003417
Scientific Title Impact of the length of stay and the medical expediture of surgical site infection in Japanese hospital
Date of disclosure of the study information 2009/12/03
Last modified on 2009/11/30

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Basic information
Public title Impact of the length of stay and the medical expediture of surgical site infection in Japanese hospital
Acronym Impact of the medical expediture of surgical site infection
Scientific Title Impact of the length of stay and the medical expediture of surgical site infection in Japanese hospital
Scientific Title:Acronym Impact of the medical expediture of surgical site infection
Region
Japan

Condition
Condition CABG, Cardiac Valve, Digestive surgery, Hepato-biliary-pancreatic surgery, OB/GYN surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify the burden of SSI for medical expediture
Basic objectives2 Others
Basic objectives -Others Economic evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post operative length of stay
Post operative medical cost
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatient who received research procedure during April 1, 2006 to March 31, 2008.
(Coronary artery bypass graft, Heart valve replacement/plasty, Digestive surgery, hepatobiliary pancreatic surgery, obstetric/gynecologic surgery)
Key exclusion criteria ASA score 3<=
Emergency surgery(Cardiovascular area)
Post operative remote infection and serious complication not related by SSI
Target sample size 3800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Kusachi
Organization Toho University Ohashi Medical Center
Division name The third department of surgery
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Japan Society for Surgical Infection
Division name Clinical reserch comittee
Zip code
Address
TEL
Homepage URL http://www.gekakansen.jp/
Email

Sponsor
Institute Japan Society for Surgical Infection
Institute
Department

Funding Source
Organization Johnson & Johnson K.K.
Organization
Division
Category of Funding Organization Profit organization
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 12 Month 03 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 Enrolling by invitation
Date of protocol fixation
2009 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There are some reports about impact of the medical expenditure of surgical site infection in many countries.

Management information
Registered date
2009 Year 11 Month 30 Day
Last modified on
2009 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003417

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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