UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014944 |
|---|---|
| Receipt number | 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 16:47:01 |
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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
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
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
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
fatehollow2000@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017388
