UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034236 |
|---|---|
| Receipt number | R000039021 |
| Scientific Title | A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2018/09/21 21:36:26 |
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Basic information
Public title
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Acronym
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Scientific Title
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Scientific Title:Acronym
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of robot assisted resection of primary colorectal cancer using the da Vinci Si surgical system
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The conversion rate to open surgery
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
robot-assisted colorectal cancer surgery using the da Vinci Si Surgical System
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Pathologically confirmed colorectal cancer
2. Patient has no distant metastases
3. Patient age is more than 20 years old, less than 80 years old.
4. Performance status is 0 or 1.
5. Tumor without invasion to other organ
6. Informed consent by a document is acquired.
Key exclusion criteria
1. Mental disorder
2. Platelet less than 50,000/ul or PT(prothrombin time) less than 80%
3. Liver dysfunction (AST, ALT: more than 100 IU/l)
4. Renal disfunction (eGFR : less than 29ml/min)
5. Severe cardiac dysfunction (Ejection Fraction less than 30%)
6. Severe adhesion is expected by past operations
7. Blood transfusion is not permitted
8. The attending physician decides that the patient is unfit for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomichi Kiyomatsu |
Organization
National Center for Global Health and Medicine
Division name
Devision of Coloproctology
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
kiyomatan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomichi Kiyomatsu |
Organization
National Center for Global Health and Medicine
Division name
Devision of Coloproctology
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
kiyomatan@yahoo.co.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
Address
Tel
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 | 09 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039021
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
