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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034236
Receipt No. 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

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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
Email 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
Email kiyomatan@yahoo.co.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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