UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007402 |
|---|---|
| Receipt number | R000008723 |
| Scientific Title | Examination of the influence that art of urinary diversion using an intestinal tract gives to digestive mucous of the gastrointestinal tract |
| Date of disclosure of the study information | 2012/02/28 |
| Last modified on | 2013/08/30 09:05:23 |
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Basic information
Public title
Examination of the influence that art of urinary diversion using an intestinal tract gives to digestive mucous of the gastrointestinal tract
Acronym
Examination of the influence that art of urinary diversion using an intestinal tract gives to digestive mucous of the gastrointestinal tract
Scientific Title
Examination of the influence that art of urinary diversion using an intestinal tract gives to digestive mucous of the gastrointestinal tract
Scientific Title:Acronym
Examination of the influence that art of urinary diversion using an intestinal tract gives to digestive mucous of the gastrointestinal tract
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the influence that no eating and drinking after total cystectomy gives to digestive mucous of the gastrointestinal tract by the measurement such as the blood DAO activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
THE blood DAO activity was relation with the fast period,influence by the age and relation by the urinary diversion
Key secondary outcomes
Retinol combination protein, blood fatty acid compartmentation were relation with the fast period,influence by the age and relation by the urinary diversion
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient recieved urinary diversion using an intestinal tract.
The patient recieved postoperetive total parenteral nutrition.
Key exclusion criteria
The patient can not recieved total parenteral nutrition.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenjirou Hayashi |
Organization
Kyorin university Hospital
Division name
Urology
Zip code
Address
6-20-2sinkawa mitakasi tokyo japan
TEL
0422-47-5511
hayashik@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hayashi |
Organization
Kyorin university Hospital
Division name
Urology
Zip code
Address
6-20-2 sinkawa mitakashi tokyo
TEL
0422-475511
Homepage URL
hayashik@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Urology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 02 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Evaluation by a periodical blood test, the weight measurement.
Management information
Registered date
| 2012 | Year | 02 | Month | 28 | Day |
Last modified on
| 2013 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008723
