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Recruitment status Completed
Unique ID issued by UMIN UMIN000014944
Receipt No. R000017388
Scientific Title a study to evaluate the efficacy of early removal of the catheter after laparoscopic radical prostatectomy
Date of disclosure of the study information 2014/08/26
Last modified on 2016/02/25

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Basic information
Public title a study to evaluate the efficacy of early removal of the catheter after laparoscopic radical prostatectomy
Acronym a study to evaluate the efficacy of early removal of the catheter after laparoscopic radical prostatectomy
Scientific Title a study to evaluate the efficacy of early removal of the catheter after laparoscopic radical prostatectomy
Scientific Title:Acronym a study to evaluate the efficacy of early removal of the catheter after laparoscopic radical prostatectomy
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present prospective study was designed to determine whether the urinary catheter could be safely removed on POD 2 or 4 after laparoscopic radical prostatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complications
continence rate
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Group 1: the urethral catheter removed on postoperative day 2
Interventions/Control_2 Group 2: the catheter removed on postoperative day 4
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. patinets who can understand this study and decide to join it
2. patients who underwent laparoscopic radical prostatectomy for organ confined prostate cancer
Key exclusion criteria 1) The patients with urinary-tract infection
2) The patients with urethral stricture
3) The patients who had experienced radiotherapy, those who were treated with any previous prostatic, bladder neck, urethral or pelvic surgery
4) The patients with urinary incontinence before laparoscopic radical prostatectomy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Miyajima
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email akiram@a8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Matsushima
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email fatehollow2000@yahoo.co.jp

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Urology, Keio University School of Medicine
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
2014 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In terms of the risk of urinary incontinence after LRP, in most patients, urinary catheter removal was safer on POD 4 than on POD 2.
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 Completed
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 26 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 08 Month 25 Day
Last modified on
2016 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017388


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