UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052120 |
|---|---|
| Receipt number | R000059490 |
| Scientific Title | Prospective observational study for surgeon's fatigue in robot-assisted and laparoscopic gastrectomy for gastric cancer: an ancillary study of the JCOG1907 randomized controlled trial |
| Date of disclosure of the study information | 2023/09/18 |
| Last modified on | 2025/03/06 17:13:19 |
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Basic information
Public title
Prospective observational study for surgeon's fatigue in robot-assisted and laparoscopic gastrectomy for gastric cancer: an ancillary study of the JCOG1907 randomized controlled trial (JCOG1907A1)
Acronym
Prospective observational study for surgeon's fatigue in robot-assisted and laparoscopic gastrectomy for gastric cancer: an ancillary study of the JCOG1907 randomized controlled trial (JCOG1907A1)
Scientific Title
Prospective observational study for surgeon's fatigue in robot-assisted and laparoscopic gastrectomy for gastric cancer: an ancillary study of the JCOG1907 randomized controlled trial
Scientific Title:Acronym
Prospective observational study for surgeon's fatigue in robot-assisted and laparoscopic gastrectomy for gastric cancer: an ancillary study of the JCOG1907 randomized controlled trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess surgeon fatigue using multiple evaluation tools and exploratively investigate the superiority of robot-assisted gastrectomy over laparoscopic gastrectomy in surgeon fatigue
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the average NASA-Task Load Index (NASA-TLX) value for the lead surgeons
Key secondary outcomes
the six individual parameters of NASA-TLX, visual analog scale assessments for fatigue, advanced trail making tests, and continuous heart rate variability measurements for surgeons
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The lead surgeon and the first assistant performing the protocol surgeries in JCOG1907 trial
Key exclusion criteria
No written consent from the lead surgeon, first assistant, or patients in the JCOG1907 trial
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Terashima |
Organization
Shizuoka Cancer Center
Division name
Division of gastric surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
m.terashima@scchr.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Fujiya |
Organization
Shizuoka Cancer Center
Division name
Division of gastric surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ke.fujiya@scchr.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
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
Shizuoka Cancer Center Institutional Review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
rinsho_office@scchr.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
| 2023 | Year | 09 | Month | 18 | 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
| 2023 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study of surgical fatigue in surgeons and first assistants in the JCOG1907 trial
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059490
