UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015697 |
|---|---|
| Receipt number | R000018246 |
| Scientific Title | The effect of TJ-54 for post-operative delirium in digestive surgery |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2014/11/15 08:25:49 |
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Basic information
Public title
The effect of TJ-54 for post-operative delirium in digestive surgery
Acronym
The effect of TJ-54 for post-operative delirium in digestive surgery
Scientific Title
The effect of TJ-54 for post-operative delirium in digestive surgery
Scientific Title:Acronym
The effect of TJ-54 for post-operative delirium in digestive surgery
Region
| Japan |
Condition
Condition
Digestive surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefullness of TJ-54 for post-operative delirium in digestive surgery in elderly patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
The incidence of post operative delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TJ-54
Interventions/Control_2
No medicine
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Operative procedure:Open and Laparoscopy
2.PS:0-2
3.Yea:70 over
4.SEX:Both
5.Hospital stay
6.Informed consent
7.Oral intake
Key exclusion criteria
1.Chemo therapy
2.Intra-operative radiotherapy
3.Post operative respiratoy assist
4.CBD
5.Emergency operation
6.Other organ failure
7.Other kampo medicine
8.Doctor's decision
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University
Division name
Digestive Surgery
Zip code
Address
Tokushima-shi
TEL
088-633-9698
mitsuo.shimada@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kozo Yoshikawa |
Organization
Tokushima University
Division name
Digestive Surgery
Zip code
Address
Tokushima-shi
TEL
088-633-9276
Homepage URL
yoshikawa.kozo@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
| 2014 | Year | 12 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018246
| 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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