UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043785 |
|---|---|
| Receipt number | R000045724 |
| Scientific Title | The evaluation of motor evoked potential from urinary muscle in surgery for rectal cancer |
| Date of disclosure of the study information | 2021/03/30 |
| Last modified on | 2021/03/30 15:43:19 |
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Basic information
Public title
The evaluation of motor evoked potential from urinary muscle in surgery for rectal cancer
Acronym
Urinary muscle-motor evoked potential
Scientific Title
The evaluation of motor evoked potential from urinary muscle in surgery for rectal cancer
Scientific Title:Acronym
Urinary muscle-motor evoked potential
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Motor evoked potential from urinary sphincter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of baseline motor evoked potential from urinary sphincter
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intraoperative monitoring of motor evoked potential from urinary sphincter
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient undergoing surgery for rectal cancer
2. Age equal or more than 20 years old
3. Male or female
Key exclusion criteria
1. Emergency operation
2. Implanted cardiac pacemaker
3. Epilepsy
4. Motor dysfunction (manual muscle test equal or less than grade 3)
5. Self-catheterization
6. Disturbed consciousness
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Hayashi |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
payashi77@hotmail.com
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Hayashi |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
payashi77@hotmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Anesthesiology, Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
payashi77@hotmail.com
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
| 2021 | Year | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045724
