UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014349 |
|---|---|
| Receipt number | R000016695 |
| Scientific Title | Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/06/23 14:02:47 |
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Basic information
Public title
Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer
Acronym
Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer
Scientific Title
Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer
Scientific Title:Acronym
Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In a large intestine malignant tumor case, a possibility of becoming an operation system which is equivalent to laparoscopic surgery and replaces validity and safety for it by carrying out comparison examination with the conventional operation under laparoscopy using an operation support robot "da Vinci Si operation system" is verified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Intraoperative and postoperative complication
(2) Operation time and operative bleeding loss
(3) Postoperative progress
(4) Pathological finding
Key secondary outcomes
(1) Disease-Free survival
(2) Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The colorectal cancer operation by the robot-assisted surgery using the da Vinci Si operation system
30 cases
Interventions/Control_2
Laparoscopic surgery for colorectal cancer
30 cases
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) The patient who has the large intestine malignant tumor adaptation of the operation under laparoscopy was indicated to be by scrutinization.
(2) The patient who does not have complications with poor control.
(3) A patient with the intention of following a research protocol.
(4) the patient whom the person himself/herself has signed.
Key exclusion criteria
(1) The patient who has multiple cancer.
(2) The patient who has history of multiple laparotomy.
(3) The patient who has critical complications.
(4) The patient who has merged the mental disease or the neurological manifestation and is judged that participation is difficult by research.
(5) The patient whom the principal investigator or the assignment researcher judged to be unsuitable to this research participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kojima |
Organization
Juntedo University Hospital
Division name
Coloproctological Surgery
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yutachan@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Kojima |
Organization
Juntedo University Hospital
Division name
Coloproctological Surgery
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
yutachan@juntendo.ac.jp
Sponsor or person
Institute
Dwpartment of Coloproctological Surgery, Juntedo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntedo University Hospital
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
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 04 | 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
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2014 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016695
