UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001330 |
|---|---|
| Receipt number | R000001615 |
| Scientific Title | Evaluation of efficacy and safty of laparoscopic intravesical surgeries |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2010/02/22 15:09:58 |
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Basic information
Public title
Evaluation of efficacy and safty of laparoscopic intravesical surgeries
Acronym
Evaluation of efficacy and safty of laparoscopic intravesical surgeries
Scientific Title
Evaluation of efficacy and safty of laparoscopic intravesical surgeries
Scientific Title:Acronym
Evaluation of efficacy and safty of laparoscopic intravesical surgeries
Region
| Japan |
Condition
Condition
Patients with lower urinary tract diseases of which intravesical surgeries are indicated for the treatments
1.Vesicoureteral reflux
2.Megaureter
3.Bladder diverticulum
4.Ureterocele
5.Hypogenesis of bladder neck
etc.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of laparoscopic intravesical surgeries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Postoperative improvement rate of diseases
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
After insertion of laparoscopic trocars, intravesical surgery is performed with insufflation of CO2 gas
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lower urinary tract diseases of which intravesical surgeries are indicated for the treatments
1.Vesicoureteral reflux
In pediatric cases, breakthrough infection, progression of renal dysfunction or
without spontaneous resolution, etc.
In adult cases, repeated UTI, progression of renal dysfunction or females after
puberty who has possibility of pregnancy, etc.
2.Megaureter
Repeated UTI, progression of renal dysfunction, symptoms such as back pain,
without spontaneous resolution, etc.
3.Bladder diverticulum, Ureterocele
Repeated UTI, severe voiding dysfunction, etc.
4.Hypogenesis of bladder neck
Severe urinary incontinence
etc.
Key exclusion criteria
1.Past history of intravesical surgery
2.Existence or past history of urothelial cancer
3.Severe complication such as heart or pulmonary disease
4.Active infection
5.Fever of 37.5 centigrade or higher
6.Pregnacy
7.Judged inappropriate with other reason by the project investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Kawauchi |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
Address
Kajii-cho, Kawaramchi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5595
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Kawauchi |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
Address
Kajii-cho, Kawaramchi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5595
Homepage URL
kawauchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 21 | Day |
Last modified on
| 2010 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001615
