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

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 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


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

Value
https://center6.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