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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014474
Receipt No. 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

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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
Institute Itabashi Chuo medical center
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 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
URL(English) https://upload.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


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