UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055295 |
|---|---|
| Receipt number | R000063181 |
| Scientific Title | Examination of the stress and fatigue exerted on surgerons and asistants by laparoscopic and robot-assisted colorectal cancer surgery |
| Date of disclosure of the study information | 2024/09/10 |
| Last modified on | 2024/08/20 22:02:47 |
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Basic information
Public title
Examination of the stress and fatigue exerted on surgerons and asistants by laparoscopic and robot-assisted colorectal cancer surgery
Acronym
Examination of the stress and fatigue exerted on surgerons and asistants by laparoscopic and robot-assisted colorectal cancer surgery
Scientific Title
Examination of the stress and fatigue exerted on surgerons and asistants by laparoscopic and robot-assisted colorectal cancer surgery
Scientific Title:Acronym
Examination of the stress and fatigue exerted on surgerons and asistants by laparoscopic and robot-assisted colorectal cancer surgery
Region
| Japan |
Condition
Condition
Surgeons who performed robotic and laparoscopic surgery
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a dry-lab study, 10 surgeons with experience in conventional laparoscopic manipulation, as well as those with experience in performing the Senhance or Da vinchi procedure, were asked to perform the same task for comparison, and their muscle fatigue and mental fatigue levels were compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EMG, ECG, respiration, SpO2, and questionnaire will be obtained, and EMG analysis and heart rate variability analysis will be performed using APDF analysis based on the acquired biological data.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
In a dry-lab study, 10 surgeons with experience in conventional laparoscopic manipulation, as well as those with experience in performing the Senhance or Da vinchi procedure, were asked to perform the same task for comparison, and their muscle fatigue and mental fatigue levels were compared.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgeons with experience in robotic surgery
Key exclusion criteria
Surgeons with arrhythmia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Okazaki |
Organization
Saitama Medical University International Medical Center
Division name
Gastrointestinal surgery
Zip code
3501298
Address
1397-1 yamane hidaka city saitama
TEL
0429844111
naotooka7010@gmail.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Okazaki |
Organization
Saitama Medical University International Medical Center
Division name
Gastrointestinal surgery
Zip code
3501298
Address
1397-1 yamane hidaka city saitama
TEL
0429844111
Homepage URL
naotooka7010@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama Medical University International Medical Center
Address
1397-1 yamane hidaka city saitama
Tel
0429844111
naotooka7010@gmail.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
| 2024 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063181
