UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of robot assisted laparoscopic colorectal surgery
Acronym	Clinical study of robot assisted laparoscopic colorectal surgery
Scientific Title	Clinical study of robot assisted laparoscopic colorectal surgery
Scientific Title:Acronym	Clinical study of robot assisted laparoscopic colorectal surgery
Region	Japan

Condition
Condition	colorectal malignant diseases
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of robot assisted colorectal surgery
Basic objectives2	Others
Basic objectives -Others	Oncological outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	rate of adverse event
Key secondary outcomes	overall survival disease free survival completion rate of robot assisted surgery

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	Maneuver
Interventions/Control_1	Robot assisted surgery
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	Resectable colorectal malignant diseases
Key exclusion criteria	transverse colon malignant diseases
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Tomoharu Middle name Last name Shimizu
Organization	Shiga University of Medical Science
Division name	Division of Gastrointestinal Surgery, Department of Surgery
Zip code	520-2192
Address	Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
TEL	077-548-2238
Email	tomoharu@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Tomoharu Middle name Last name Shimizu
Organization	Shiga University of Medical Science
Division name	Division of Gastrointestinal Surgery, Department of Surgery
Zip code	520-2192
Address	Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
TEL	077-548-2111
Homepage URL
Email	tomoharu@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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	Shiga University of Medical Science, Research Ethics Office
Address	Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
Tel	077-548-2111
Email	hqrec@belle.shiga-med.ac.jp

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	滋賀医科大学附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	5
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	2013 Year 07 Month 23 Day
Date of IRB	2013 Year 12 Month 31 Day
Anticipated trial start date	2014 Year 06 Month 06 Day
Last follow-up date	2022 Year 03 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	2014 Year 10 Month 07 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017880