UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008962
Receipt number R000010496
Scientific Title Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access
Date of disclosure of the study information 2012/09/23
Last modified on 2012/09/23 10:32:57

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Basic information

Public title

Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access

Acronym

Impact of ureteroscopy in the modified Valdivia position

Scientific Title

Impact of ureteroscopy in the modified Valdivia position for management of upper urinary tract stone disease; A comparison of mono- and dual access

Scientific Title:Acronym

Impact of ureteroscopy in the modified Valdivia position

Region

Japan


Condition

Condition

upper urinary tract stone (stone size >15mm) disease patients who were scheduled for ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively in our hospital

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Percutaneous nephrolithotomy (PCNL) is the gold standard treatment for large stone burdens and staghorn calculi. The modified Valdivia position supports a versatile approach to the upper urinary tract, and is beginning to be accepted by urologists. This approach allows for simultaneous percutaneous and ureteroscopic access to facilitate stone clearance. In our hospital, we use ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

safety and effectiveness to perform ureteroscopy along with PCNL while maintaining the modified Valdivia position.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

ureteroscopy in the modified Valdivia position

Interventions/Control_2

ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively

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

upper urinary tract stone (stone size > 15mm) patients who were scheduled for ureteroscopy and add PCNL in the modified Valdivia position only if judged necessary intraoperatively in our hospital

Key exclusion criteria

1. refractory anti-coagulant therapy
2. refractory immunosuppressant therapy
3. refractory diabetes mellitus
4. refractory urinary tract infection
5. anesthsiological unfavorable conditions including circulatory, respiratory, and hepatorenal disease
6. complete staghorn calculi

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noritaka Ishito

Organization

Kurashiki Medical Center

Division name

Dept. of Urology

Zip code


Address

250 Bakurocho, Kurashiki City

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kurashiki Medical Center

Division name

Dept. of Urology

Zip code


Address


TEL

086-422-2111

Homepage URL


Email



Sponsor or person

Institute

Kurashiki Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

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


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

倉敷成人病センター


Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 23 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

Preinitiation

Date of protocol fixation

2012 Year 09 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 21 Day

Last follow-up date

2017 Year 12 Month 21 Day

Date of closure to data entry

2017 Year 12 Month 21 Day

Date trial data considered complete

2017 Year 12 Month 21 Day

Date analysis concluded

2017 Year 12 Month 21 Day


Other

Other related information



Management information

Registered date

2012 Year 09 Month 23 Day

Last modified on

2012 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name