UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Robot-assisted Surgery for rectal tumor
Title of the study (Brief title)	Study of Robot-assisted Surgery for rectal tumor
Region	Japan

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

Objectives
Narrative objectives1	assessment of feasibility and safety of robot-assisted rectal surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	frequency of adverse events
Key secondary outcomes	recurrence, prognosis

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	The use of robot-assisted surgical system for laparoscopic rectal 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	Not applicable
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients with rectal tumors who are applicable for laparoscopic rectal surgery. (2) Written informed consent is essential.
Key exclusion criteria	(1)Woman in pregnancy or woman of child bearing potential and breast-feeding woman. (2)Patients with psychiatric disease. (3)Cases which the investigators think inadequate to this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Daisuke Kuroda
Organization	Kobe University
Division name	Department of Surgery
Address	7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL	+81-78-382-5925
Email	sumiy@med.kobe-u.ac.jp

Public contact
Name of contact person	Yasuo Sumi
Organization	Kobe University
Division name	Department of Surgery
Address	7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL	078-382-5925
Homepage URL
Email	sumiy@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	none
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	2011 Year 01 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 01 Month 06 Day
Anticipated trial start date	2011 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	2011 Year 01 Month 06 Day
Last modified on	2017 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005746