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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003133
Receipt No. R000003770
Scientific Title Evaluation of serodiagnosis (beta-D-glucan) screening for invasive fungal infection on intracavitary surgical site infection(SSI)
Date of disclosure of the study information 2010/02/03
Last modified on 2014/04/30

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Basic information
Public title Evaluation of serodiagnosis (beta-D-glucan) screening for invasive fungal infection on intracavitary surgical site infection(SSI)
Acronym Evaluation of beta-D-glucan screening for invasive fungal infection on intracavitary SSI
Scientific Title Evaluation of serodiagnosis (beta-D-glucan) screening for invasive fungal infection on intracavitary surgical site infection(SSI)
Scientific Title:Acronym Evaluation of beta-D-glucan screening for invasive fungal infection on intracavitary SSI
Region
Japan

Condition
Condition Gastrointestinal surgical patients
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determination of appropriate timing of antifungal treatment and risk factor of fungal infections based on the incidence of perioperative fungal infection in patients after gastrointestinal surgery
Basic objectives2 Others
Basic objectives -Others Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive ratio of beta-D-glucan at onset of intracavitary surgical site infections
Fungal culture tests
Key secondary outcomes Incidence of fungal infections at each surgical site
Clinical risk factors for fungal infections
Usefulness of antifungal treatment

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who develop perioperative intracavitary surgical site infection after gastrointestinal surgery
Key exclusion criteria Pregnant or patients might be pregnant ,and lactating patients
Patients treated with antifungal at study registration
Patients diagnosed as fungal infections at study registration
Patients not expected to survive during study due to very serious underlying disease or infection
Patients considered as inappropriate for study by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University Graduate School of Medicine
Division name Division of Hepato-Biliary Pancreatic Surgery Department of Surgery
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai
TEL 022-717-7205
Email kein_h11@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Integrated Surgery and Oncology
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai
TEL 022-717-7205
Homepage URL
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Miyagi study group for gastrointestinal surgical infection
Institute
Department

Funding Source
Organization Miyagi study group for gastrointestinal surgical infection
Organization
Division
Category of Funding Organization Other
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
2010 Year 02 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 No longer recruiting
Date of protocol fixation
2010 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective investigated study of perioperative fungal infection in patients after gastrointestinal surgery

Management information
Registered date
2010 Year 02 Month 03 Day
Last modified on
2014 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003770

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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