UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017085 |
|---|---|
| Receipt number | R000019820 |
| Scientific Title | Robot (Da Vinci) -assisted colorectal surgery |
| Date of disclosure of the study information | 2015/04/09 |
| Last modified on | 2021/04/13 09:22:14 |
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Basic information
Public title
Robot (Da Vinci) -assisted colorectal surgery
Acronym
Robot-assisted colorectal surgery
Scientific Title
Robot (Da Vinci) -assisted colorectal surgery
Scientific Title:Acronym
Robot-assisted colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessing the safety and efficacy of robot-assisted colorectal cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operation time, blood loss
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 surgery using da Vinci Surgical System will be performed.
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. Colorectal cancer proven histologically.
2. No distant metastasis.
3. No invasion to the adjacent organ.
4. Age under 80
5. Performance Status 0 / 1
6. Written informed consent.
Key exclusion criteria
1. abalienation or disorder of other cognitive functioning
2. Platelet count under 50,000/micro-litter, prothrombin time under 80%
3. Severe disorder of liver function
4. Severe disorder of renal function
5. Severe disorder of heart function
6. Patient with high possibility of intraabdominal adhesion
7. Patient without consent of blood transfusion
8. Other conditions judged ineligible by physician.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Watanabe |
Organization
The university of Tokyo
Division name
Department of surgical oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
toshwatanabe@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Sunami |
Organization
The university of Tokyo
Division name
Department of surgical oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
eijisunami@gmail.com
Sponsor or person
Institute
Department of surgical oncology,
The university of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 04 | Month | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
