UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018908 |
|---|---|
| Receipt number | R000020714 |
| Scientific Title | The study of the quality of life of the patients after Fontan operation |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2015/09/04 10:34:39 |
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Basic information
Public title
The study of the quality of life of the patients after Fontan operation
Acronym
Fontan QOL study
Scientific Title
The study of the quality of life of the patients after Fontan operation
Scientific Title:Acronym
Fontan QOL study
Region
| Japan |
Condition
Condition
post Fontan operation
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the quality of life of the patients who underwent Fontan surgery previously
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores of SF-36
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with complex congenital heart disease who received Fontan operation between January 1971 and March 2015.
Key exclusion criteria
none
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomi Ide |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5360
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Sakamoto |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5360
Homepage URL
ichiro@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Donated funds
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka Children's Hospital
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
| 2015 | Year | 09 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020714
| 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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| Registered date | File name |
