UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of robot assisted colorectal cancer surgery using the da Vinci surgical system
Title of the study (Brief title)	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	Yoshihiko Maehara
Organization	Kyushu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5466
Email	maehara@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eiji Oki
Organization	Kyushu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5466
Homepage URL
Email	okieiji@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020257