UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Title of the study (Brief title)	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	Tomomichi Kiyomatsu
Organization	National Center for Global Health and Medicine
Division name	Devision of Coloproctology
Address	1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL	03-3202-7181
Email	kiyomatan@yahoo.co.jp

Public contact
Name of contact person	Tomomichi Kiyomatsu
Organization	National Center for Global Health and Medicine
Division name	Devision of Coloproctology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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