UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014474
Receipt number R000016829
Scientific Title Randomized evaluation of the necessity of indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery (RIRS)
Date of disclosure of the study information 2014/07/04
Last modified on 2014/07/04 09:42:57

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Basic information

Public title

Randomized evaluation of the necessity of indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery (RIRS)

Acronym

Randomized evaluation of the necessity of indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery (RIRS)

Scientific Title

Randomized evaluation of the necessity of indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery (RIRS)

Scientific Title:Acronym

Randomized evaluation of the necessity of indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery (RIRS)

Region

Japan


Condition

Condition

Upper urinary tract calculi

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the necessity of indwelling urethral catheter based on intensity of pain and morbidity after retrograde intra renal surgery for upper urinary tract calculi

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

intensity of postoperative pain (using numeric rating scale)

Key secondary outcomes

the location and distribution of postoperative pain, the amount of consumed painkillers for postoperative pain, the incidence of postoperative urinary tract infection, the state and symptom of urination,quality of life, length of hospital stay


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery

Interventions/Control_2

No indwelling urethral catheter for patients with upper urinary tract calculi under retrograde intra renal surgery

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who received retrograde intra renal surgery for upper urinary tract calculi under general anesthesia
2) Patients who have spontaneous normal urination with less than 100ml post voiding residual urine

Key exclusion criteria

1) Inappropriate patients for general anesthesia
2) Intraoperative severe complications
3) Patients with preoperative percutaneous nephrostomy or ureteral stenting
4) Patients with disturbance of motility or sensation
5) Patients with operative treatment history for prostatic diseases
6)Patients who received simultaneous other transurethral surgeries
7)Patients who received ureteral dilation simultaneously
8)Patients with drug allergy for NSAIDs
9)Patients who do not wish to participate in this clinical study
10)Pregnant women or nursing mothers
11)Patients judged as inappropriate by treating physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinsuke Okada

Organization

Itabashi Chuo medical center

Division name

Department of urology

Zip code


Address

2-12-7, Azusawa, Itabashi, Tokyo 174-0051, Japan

TEL

03-3967-1181

Email

okada.shinsuke@ims.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinsuke Okada

Organization

Itabashi Chuo medical center

Division name

Department of urology

Zip code


Address

2-12-7, Azusawa, Itabashi, Tokyo 174-0051, Japan

TEL

03-3967-1181

Homepage URL


Email

okada.shinsuke@ims.gr.jp


Sponsor or person

Institute

Itabashi Chuo medical center

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

豊田厚生病院(愛知県)、関西医科大学付属滝井病院(大阪府)、行徳総合病院(千葉県)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 04 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

Open public recruiting

Date of protocol fixation

2014 Year 05 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 24 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

2014 Year 07 Month 04 Day

Last modified on

2014 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016829


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name