UMIN-CTR Clinical Trial

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
Email	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
Email	payashi77@hotmail.com

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045724