UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016214 |
|---|---|
| Receipt number | R000018816 |
| Scientific Title | A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2018/09/08 08:16:50 |
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Basic information
Public title
A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Acronym
OLSES study
Scientific Title
A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Scientific Title:Acronym
OLSES study
Region
| Japan |
Condition
Condition
Renal ureteral calculi
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I study the optimal length of ureteral stent extraction string is not drawn into the urethra.
Basic objectives2
Others
Basic objectives -Others
The optimal length of ureteral stent extraction string is not drawn into the urethra.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
The optimal length of ureteral stent extraction string is not drawn into the urethra.
Key secondary outcomes
Urination QOL
Complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
I rermove ureteral stent using ureteral stent extraction string.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent TUL for renal and urinary tract stones.
Patients who can walk independence (Performance status: PS<=1).
Key exclusion criteria
Communicate difficult cases.
If the doctor has determined ineligible during surgery.
PS>=2
The cases an attending physician determined ineligible.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Kansai Medical University Takii Hospital
Division name
Urology
Zip code
Address
Fumizonocho, 10-15, Moriguchi, Osaka
TEL
06-6992-1001(42206)
taguchim@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Kansai Medical University Takii Hospital
Division name
Urology
Zip code
Address
Fumizonocho, 10-15, Moriguchi, Osaka
TEL
06-6992-1001(42206)
Homepage URL
taguchim@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Takii Hospital Urology
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
関西医科大学附属滝井病院/ Kansai Medical University Takii Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018816
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
