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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017022
Receipt No. R000018420
Scientific Title The effectiveness and safety of robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Date of disclosure of the study information 2015/04/06
Last modified on 2018/10/04

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Basic information
Public title The effectiveness and safety of robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Acronym The effectiveness and safety of robot assisted laparoscopic colorectal surgery.
Scientific Title The effectiveness and safety of robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Scientific Title:Acronym The effectiveness and safety of 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 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 ,histopathological findings of surgical margin

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 Maneuver
Interventions/Control_1 robot assisted laparoscopic colorectal 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 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
1st name
Middle name
Last name Toshisada Aiba
Organization Toyohashi municipal hospital
Division name department of general surgery
Zip code
Address 50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL +81-532-33-6111
Email toshisada5445@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshisada Aiba
Organization Toyohashi municipal hospital
Division name department of general surgery
Zip code
Address 50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL +81-532-33-6111
Homepage URL
Email toshisada5445@hotmail.co.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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2021 Year 06 Month 21 Day
Date of closure to data entry
2021 Year 06 Month 21 Day
Date trial data considered complete
2021 Year 06 Month 21 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 02 Day
Last modified on
2018 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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