UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031195 |
|---|---|
| Receipt number | R000034893 |
| Scientific Title | Visualization of the urethra using a lighted urethral stent in operations for low rectal cancer |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2025/08/14 16:11:39 |
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Basic information
Public title
Visualization of the urethra using a lighted urethral stent in operations for low rectal cancer
Acronym
Visualization of the urethra using a lighted urethral stent in operations for low rectal cancer
Scientific Title
Visualization of the urethra using a lighted urethral stent in operations for low rectal cancer
Scientific Title:Acronym
Visualization of the urethra using a lighted urethral stent in operations for low rectal cancer
Region
| Japan |
Condition
Condition
low rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of visualization of the urethra using a lighted stent in operations for low rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Detection rate of the urethra
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lighted stent is placed into the urethra through urinary catheter during operation
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who have one of three surgical procedure: 1)Intersphincteric resection(ISR); 2)Abdominoperineal resection (APR); or 3)Total pelvic exenteration(TPE).
Key exclusion criteria
1)Rejection cases
2)Ineligible cases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Obama |
| Middle name | |
| Last name | Kazutaka |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
606-8507
Address
54, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kawada |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
606-8507
Address
54, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
kkawada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Laparoscopic Colorectal Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
(e-mail) ethcom@kuhp.kyoto-u.ac.jp
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
| 2018 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034893
