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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007402
Receipt No. 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

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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
Email 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
Email hayashik@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University Urology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008723

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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