UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025313 |
|---|---|
| Receipt number | R000029050 |
| Scientific Title | Changes in presepsin concentrations after colorectal surgery |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2023/06/26 11:01:09 |
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Basic information
Public title
Changes in presepsin concentrations after colorectal surgery
Acronym
Changes in presepsin concentrations after colorectal surgery
Scientific Title
Changes in presepsin concentrations after colorectal surgery
Scientific Title:Acronym
Changes in presepsin concentrations after colorectal surgery
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the kinetics of presepsin after colorectal surgery for the early detection of postoperative infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparison of presepsin concentrations in groups with infectious complications and without infections comlications
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients who undergo elective colorectal surgery
Key exclusion criteria
preoperative infectious diseases
end-stage kidney desease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kishiko Nakai |
Organization
Hirosaki University Hospital
Division name
Department of Anesthesiology
Zip code
Address
53 Hontyo, Hirosaki, Aomori
TEL
0172-39-5113
kishiko_sk1064@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kishiko Nakai |
Organization
Hirosaki University Hospital
Division name
Department f Anesthesiology
Zip code
Address
53 Hontyo, Hirosaki, Aomori
TEL
0172-39-5113
Homepage URL
kishiko_sk1064@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki university
Institute
Department
Personal name
Funding Source
Organization
Hirosaki university
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
| 2016 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We completed the study and published the results as a paper.
Management information
Registered date
| 2016 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029050
