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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001330
Receipt No. 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

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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
Email

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
Email kawauchi@koto.kpu-m.ac.jp

Sponsor
Institute Department of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001615

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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