UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040213 |
|---|---|
| Receipt number | R000045866 |
| Scientific Title | Learning curve of kidney transplantation |
| Date of disclosure of the study information | 2020/04/21 |
| Last modified on | 2020/07/19 23:10:28 |
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Basic information
Public title
Learning curve of kidney transplantation in a high-volume center
Acronym
Learning curve of kidney transplantation
Scientific Title
Learning curve of kidney transplantation
Scientific Title:Acronym
Learning curve of kidney transplantation
Region
| Europe |
Condition
Condition
recipients who underwent kidney transplantation
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the learning curve model for KTX using the CUSUM analysis in a high-volume center.
Basic objectives2
Others
Basic objectives -Others
na
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study was to evaluate the learning curve model for KTX using the CUSUM analysis in a high-volume center.
Key secondary outcomes
Furthermore, we explored the necessary number of procedures to improve surgical technique.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recipients who underwent KTX at the Erasmus MC, University Medical Centre Rotterdam, The Netherlands, between June 2010 and December 2017.
Key exclusion criteria
pediatric recipients
Target sample size
1466
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Erasmus MC
Division name
Surgery
Zip code
3015 GD
Address
Dr. Molewaterplein 40,
TEL
+31643802627
k.takagi@erasmusmc.nl
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Erasmus MC
Division name
Surgery
Zip code
3015 GD
Address
Dr. Molewaterplein 40,
TEL
+31643802627
Homepage URL
k.takagi@erasmusmc.nl
Sponsor or person
Institute
Erasmus MC
Institute
Department
Personal name
Funding Source
Organization
na
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Erasmus MC
Address
Dr. Molewaterplein 40,
Tel
+31643802627
k.takagi@erasmusmc.nl
Secondary IDs
Secondary IDs
YES
Study ID_1
MEC-2019-0373
Org. issuing International ID_1
MEC-2019-0373
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045866
| 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 |
