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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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