UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017478 |
|---|---|
| Receipt number | R000020257 |
| Scientific Title | Feasibility study of robot assisted colorectal cancer surgery using the da Vinci surgical system |
| Date of disclosure of the study information | 2015/05/09 |
| Last modified on | 2018/10/02 11:47:03 |
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Basic information
Public title
Feasibility study of robot assisted colorectal cancer surgery using the da Vinci surgical system
Acronym
Feasibility study of robot assisted colorectal cancer surgery using the da Vinci surgical system
Scientific Title
Feasibility study of robot assisted colorectal cancer surgery using the da Vinci surgical system
Scientific Title:Acronym
Feasibility study of robot assisted colorectal cancer surgery using the da Vinci 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 and feasibility of robot assisted colorectal cancer surgery using the da Vinci surgical system
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate
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
Laparoscopic rectal surgery using da Vinci 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.Colorectal cancer proven by imaging study.
2.Resectable stage 0-III tumor in open surgery.
3.Age 20-80.
4.ECOG PS 0-1.
5.Adequate organ function to perform the surgery.
6. Written informed consent.
Key exclusion criteria
1.Serious co-morbidity, such as cardiopulmonary disease, bleeding tendency, uncontrollable diabetes mellitus or hypertension.
2. Bleeding tendency, coagulopathy
3..No prior radiotherapy
4. Severe renal dysfunction
5. Severe liver dysfunction
6. Other conditions judged ineligible by physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
maehara@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Oki |
Organization
Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
Homepage URL
okieiji@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 05 | 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
| 2013 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 09 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020257
