UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010393 |
|---|---|
| Receipt number | R000012158 |
| Scientific Title | Clinical trial of tissue sealing sheet for erectile dysfunction following robotic-assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2019/10/06 12:48:38 |
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Basic information
Public title
Clinical trial of tissue sealing sheet for erectile dysfunction following robotic-assisted laparoscopic prostatectomy
Acronym
Clinical trial of tissue sealing sheet for erectile dysfunction following radical prostatectomy
Scientific Title
Clinical trial of tissue sealing sheet for erectile dysfunction following robotic-assisted laparoscopic prostatectomy
Scientific Title:Acronym
Clinical trial of tissue sealing sheet for erectile dysfunction following radical prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tissue sealing sheet for erectile dysfunction following robotic-assisted laparoscopic prostatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erectile function scores in the validated expanded prostate cancer index composite questionnaire (EPIC)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of TachoSil tissue sealing sheet on the sparing neurovascular bundle
Interventions/Control_2
Non-Use of TachoSil tissue sealing sheet on the sparing neurovascular bundle
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
Nerve-sparing robotic-assisted laparoscopic prostatectomy will be performed for prostate cancer.
Key exclusion criteria
Androgen deprivation therapy is performed before robotic-assisted laparoscopic prostatectomy.
Erectile dysfunction is severe (International Index of Erectile Function less than 7).
The patient has another cancer.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yamashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
TEL
022-717-7278
yamashita@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yamashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7278
Homepage URL
yamashita@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Urology, Tohoku University Graduate School of Medicine
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
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
| 2013 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012158
