UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of robotic assisted rectal cancer surgery using the da Vinci Surgical System
Title of the study (Brief title)	Prospective study of roboticrectal cancer surgery
Region	Japan

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

Objectives
Narrative objectives1	Safety and efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate
Key secondary outcomes	Operative time, Blood loss, Pstoperative hospital stay, Conversion rate

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 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Adenocarcinoma 2.Tumor is located in the rectum 3.cStage 0-IIIb 4.Contraindication of endoscopic resection 5.Age 20 or older 6.PS 0/1 7.Adequate organ function 8.Informed consent
Key exclusion criteria	1.In hope of open or laparoscopic surgery 2.Multiple cancer 3.Multicentric colorectal cancer 4.Ileus 5.Past history of bowel resection 6.Uncontrorable comorbidity 7.Unsuitable patients
Target sample size	20

Research contact person
Name of lead principal investigator	Masato Nagino
Organization	Nagoya University Gratuated School of Medicine
Division name	Division of Surgical Oncology, Department of Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-744-2222
Email	kuehara@med.nagoya-u.ac.jp

Public contact
Name of contact person	Keisuke Uehara
Organization	Nagoya University Gratuated School of Medicine
Division name	Division of Surgical Oncology, Department of Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-744-2222
Homepage URL
Email	kuehara@med.nagoya-u.ac.jp

Sponsor
Institute	Division of Surgical Oncology, Department of Surgery, Nagoya University Gratuated School of Medicine
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
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 01 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 13 Day
Anticipated trial start date	2015 Year 03 Month 01 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	2015 Year 01 Month 13 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018801