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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024772
Receipt No. R000028476
Scientific Title Study for prognosis factors of intestinal failure
Date of disclosure of the study information 2016/11/14
Last modified on 2016/11/08

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Basic information
Public title Study for prognosis factors of intestinal failure
Acronym Study for intestinal failure
Scientific Title Study for prognosis factors of intestinal failure
Scientific Title:Acronym Study for intestinal failure
Region
Japan

Condition
Condition intestinal failure
Classification by specialty
Gastroenterology Gastrointestinal surgery Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 study of intestinal failure
Basic objectives2 Others
Basic objectives -Others indication for intestinal transplant
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival
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
0 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Intestinal failure with PN over 6 months
Key exclusion criteria Intestinal failure caused by other organ origin
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroomi Okuyama
Organization Osaka University Graduate School of Medicine
Division name Pediatric Surgery
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3753
Email okuyama@pedsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehisa Ueno
Organization Osaka University Graduate School of Medicine
Division name Pediatric Surgery
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3753
Homepage URL
Email ueno@pedsurg.med.osaka-u.ac.jp

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 11 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Follow up 106 reported cases

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028476

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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