UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003133 |
|---|---|
| Receipt number | 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 18:42:05 |
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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
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
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Miyagi study group for gastrointestinal surgical infection
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003770
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
