UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008962 |
|---|---|
| Receipt number | R000010496 |
| Scientific Title | Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access |
| Date of disclosure of the study information | 2012/09/23 |
| Last modified on | 2012/09/23 10:32:57 |
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Basic information
Public title
Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access
Acronym
Impact of ureteroscopy in the modified Valdivia position
Scientific Title
Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access
Scientific Title:Acronym
Impact of ureteroscopy in the modified Valdivia position
Region
| Japan |
Condition
Condition
upper urinary tract stone (stone size >15mm) disease patients who were scheduled for ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively in our hospital
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Percutaneous nephrolithotomy (PCNL) is the gold standard treatment for large stone burdens and staghorn calculi. The modified Valdivia position supports a versatile approach to the upper urinary tract, and is beginning to be accepted by urologists. This approach allows for simultaneous percutaneous and ureteroscopic access to facilitate stone clearance. In our hospital, we use ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety and effectiveness to perform ureteroscopy along with PCNL while maintaining the modified Valdivia position.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ureteroscopy in the modified Valdivia position
Interventions/Control_2
ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
upper urinary tract stone (stone size > 15mm) patients who were scheduled for ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively in our hospital
Key exclusion criteria
1. refractory anti-coagulant therapy
2. refractory immunosuppressant therapy
3. refractory diabetes mellitus
4. refractory urinary tract infection
5. anesthsiological unfavorable conditions including circulatory, respiratory, and hepatorenal disease
6. complete staghorn calculi
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noritaka Ishito |
Organization
Kurashiki Medical Center
Division name
Dept. of Urology
Zip code
Address
250 Bakurocho, Kurashiki City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurashiki Medical Center
Division name
Dept. of Urology
Zip code
Address
TEL
086-422-2111
Homepage URL
Sponsor or person
Institute
Kurashiki Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
倉敷成人病センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 21 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 23 | Day |
Last modified on
| 2012 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010496
