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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041405
Receipt No. 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

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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
Email 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
Email k.takagi@erasmusmc.nl

Sponsor
Institute Erasmus MC
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047271

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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