UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An evaluation study of efficacy and safety of Robotic low anterior resection with da Vinci Surgical System for rectal cancer
Title of the study (Brief title)	An evaluation of Robotic low anterior resection with da Vinci
Region	Japan

Condition
Condition	rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Robotic low anterior resection using da Vinci Surgical System for rectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perioperative Morbidity and Mortality (Clavien-Dindo classification over Grade II)
Key secondary outcomes	Surgical outcomes (operation time, volume of blood loss, and conversion rate to open 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	Robotic low anterior resection with 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) histrogically and radiologically judged rectal cancer 2) applicable to laparoscopic low anterior resection 3) age 20 to 80 years 4) ECOG-Performance status of 0 to 1 5) written informed consent
Key exclusion criteria	1) severe cardiac or cerebral vascular disease 2) aspirin, warfarin or other medications induce bleeding tendency prohibited to discontinue 3) sever renal disfunction 4) severe hepatic disfunction 5) patients whose enrollement in this trial is judged to be inappropriate by the attending doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshihisa Sakaguchi
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterological Surgery
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	ysakaguchi@kyumed.jp

Public contact
Name of contact person	Yoshihisa Sakaguchi
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterological Surgery
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	ysakaguchi@kyumed.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center
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	2017 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 10 Day
Anticipated trial start date	2013 Year 11 Month 27 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	2017 Year 12 Month 12 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034674