UMIN-CTR Clinical Trial

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
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
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	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
Date of IRB	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
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	2021 Year 04 Month 13 Day

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