UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037024 |
|---|---|
| Receipt number | R000042172 |
| Scientific Title | Patient,s Quality of Life with distal ureteral stone on peri-operation, randomized controll study; multi-central institution |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/03/25 20:27:18 |
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Basic information
Public title
Patient,s Quality of Life with distal ureteral stone on peri-operation, randomized controll study; multi-central institution
Acronym
QOL study with distal stone
Scientific Title
Patient,s Quality of Life with distal ureteral stone on peri-operation, randomized controll study; multi-central institution
Scientific Title:Acronym
QOL study with distal stone
Region
| Japan |
Condition
Condition
distal ureteral stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Impact of QOL for the patients with distal ureteral stone after SWL or ureteroscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of patient,s QOL between SWL and ureteroscopy group
Key secondary outcomes
complication rate due to active treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
SWL vs ureteroscopy
Interventions/Control_2
Randomization of SWL vw URS for <10mm distal stone
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Over than 20 years
2) Perfomance status<1
3) <10mm distal ureteral stone
4) not enable to spontantous passage of stone for 2 weeks
5) not informed consent from the patient
Key exclusion criteria
1)Perfomance status>2
2)impossible to mutual understanding
3)presenting many stones in same ureter
4)X-ray negative stone
5)congenital anatomy
6)fabrile UTI
7)with pregnancy
8)inadequate case
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAKAAKI |
| Middle name | |
| Last name | INOUE |
Organization
Hara Genitourinary Hospital
Kobe University
Division name
Urology
Zip code
650-0012
Address
5-7-17 Kitanagawadori, Chuo-ku,Kobe City Hyogo
TEL
+81783711203
inouetak@harahospital.jp
Public contact
Name of contact person
| 1st name | TAKAAKI |
| Middle name | |
| Last name | INOUE |
Organization
Hara Genitourinary Hospital Kobe University
Division name
Urology
Zip code
650-0012
Address
5-7-17 Kitanagawadori, Chuo-ku,Kobe City Hyogo
TEL
+81783711203
Homepage URL
inouetak@harahospital.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Hara Genitourinary Hospital and Kobe University
Address
5-7-17 Kitanagawadori, Chuo-ku,Kobe City Hyogo
Tel
+81783711203
inouetak@harahospital.jp
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
| 2019 | Year | 09 | Month | 01 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042172
