UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006902 |
|---|---|
| Receipt number | R000008158 |
| Scientific Title | A phase ll study of robot assisted colorectal cancer surgery |
| Date of disclosure of the study information | 2011/12/18 |
| Last modified on | 2012/12/25 18:09:56 |
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Basic information
Public title
A phase ll study of robot assisted colorectal cancer surgery
Acronym
A phase ll study of robot assisted colorectal cancer surgery
Scientific Title
A phase ll study of robot assisted colorectal cancer surgery
Scientific Title:Acronym
A phase ll study of robot assisted colorectal cancer surgery
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot assisted colorectal cancer surgery
Basic objectives2
Others
Basic objectives -Others
oncological outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
rate of anastomotic leakage
Key secondary outcomes
overall survival
disease free survival
completion rate of robot assisted surgery
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
| Maneuver |
Interventions/Control_1
robot assisted surgery
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
resectable colorectal cancer
Key exclusion criteria
transverse colon cancer
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Kinugasa |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of colorectal surgery
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun Shizuoka JAPAN
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of colorectal surgery
Zip code
Address
055-989-5222
TEL
Homepage URL
Sponsor or person
Institute
Shizuoka Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka prefecture
Organization
Division
Category of Funding Organization
Local Government
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
| 2011 | Year | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 18 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008158
