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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017085
Receipt No. R000019820
Scientific Title Robot (Da Vinci) -assisted colorectal surgery
Date of disclosure of the study information 2015/04/09
Last modified on 2018/04/11

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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
Last 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
Email toshwatanabe@yahoo.co.jp

Public contact
1st 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
Email eijisunami@gmail.com

Sponsor
Institute Department of surgical oncology,
The university of Tokyo
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 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
2015 Year 04 Month 09 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019820

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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