UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness and safety of perioperative Enhanced Recovery After Surgery protocol in robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Title of the study (Brief title)	The effectiveness and safety of perioperative ERAS protocol in robot assisted laparoscopic colorectal surgery.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effectiveness of perioperative ERAS protocol in robot assisted laparoscopic colorectal surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	rate of the incidence of postoperative complications further than Grade 3 of Clavien-Dindo classification ver2.0.
Key secondary outcomes	in-hospital mortality,rate of the incidence of intra-operative complications,blood loss,operative time,rate of the incidence of all postoperative complications,length of hospital stay,postoperative mobilization day,oral intake start day,first day of the gas and feces,residual urine volume in the fifth postoperative day,completion rate of clinical path

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	perioperative ERAS protocol
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	colorectal cancer radical excision performance status(PS;ECOG) is 0 or 1 written informed consent
Key exclusion criteria	any metastasis the case that the high adhesion is predicted the case that the medical attendant judged to be inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuhiro Hiramatsu
Organization	Toyohashi municipal hospital
Division name	department of general surgery
Address	50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL	+81-532-33-6111
Email	hiramatsu-kazuhiro@toyohashi-mh.jp

Public contact
Name of contact person	Kisuke Ito
Organization	Toyohashi municipal hospital
Division name	department of general surgery
Address	50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL	+81-532-33-6111
Homepage URL
Email	ito-kisuke@toyohashi-mh.jp

Sponsor
Institute	Toyohashi municipal hospital
Institute
Department

Funding Source
Organization	Toyohashi municipal hospital
Organization
Division
Category of Funding Organization	Local Government
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	豊橋市民病院　Toyohashi Municipal Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 15 Day
Anticipated trial start date	2016 Year 08 Month 19 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	2016 Year 08 Month 19 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027285