UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041405 |
|---|---|
| Receipt number | R000047271 |
| Scientific Title | Learning curve of minimally invasive donor nephrectomy |
| Date of disclosure of the study information | 2020/08/13 |
| Last modified on | 2021/01/18 20:59:18 |
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Basic information
Public title
Learning curve of minimally invasive donor nephrectomy in a high-volume center
Acronym
Learning curve of minimally invasive donor nephrectomy
Scientific Title
Learning curve of minimally invasive donor nephrectomy
Scientific Title:Acronym
Learning curve of minimally invasive donor nephrectomy
Region
| Europe |
Condition
Condition
Living donors who underwent minimally invasive donor nephrectomy (MIDN)
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to develop a learning curve model for several MIDN using the cumulative sum (CUSUM) analysis.
Basic objectives2
Others
Basic objectives -Others
na
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The CUSUM analysis was performed to develop a learning curve model for operative time per surgeon in MIDN, and to identify the number of procedures necessary to reach optimal performance.
Key secondary outcomes
Firstly, donor characteristics and outcomes were compared in MIDN. Secondly, surgeon volumes were categorized, and outcomes were evaluated based on the groups in each procedure.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Living donorsw who underwent MIDN at the Erasmus MC, University Medical Centre Rotterdam, The Netherlands, between 1997 and 2019.
Key exclusion criteria
Living donors who underwent open donor nephrectomy.
Target sample size
1895
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 | 08 | Month | 13 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
na
Management information
Registered date
| 2020 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047271
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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