UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014349
Receipt number R000016695
Scientific Title Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer
Date of disclosure of the study information 2014/07/01
Last modified on 2014/06/23 14:02:47

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Basic information

Public title

Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer

Acronym

Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer

Scientific Title

Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer

Scientific Title:Acronym

Study of the usefulness and safety of a robot support operation using da Vinci Si operation system for colorectal cancer

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In a large intestine malignant tumor case, a possibility of becoming an operation system which is equivalent to laparoscopic surgery and replaces validity and safety for it by carrying out comparison examination with the conventional operation under laparoscopy using an operation support robot "da Vinci Si operation system" is verified.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) Intraoperative and postoperative complication
(2) Operation time and operative bleeding loss
(3) Postoperative progress
(4) Pathological finding

Key secondary outcomes

(1) Disease-Free survival
(2) Overall survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The colorectal cancer operation by the robot-assisted surgery using the da Vinci Si operation system
30 cases

Interventions/Control_2

Laparoscopic surgery for colorectal cancer
30 cases

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) The patient who has the large intestine malignant tumor adaptation of the operation under laparoscopy was indicated to be by scrutinization.
(2) The patient who does not have complications with poor control.
(3) A patient with the intention of following a research protocol.
(4) the patient whom the person himself/herself has signed.



Key exclusion criteria

(1) The patient who has multiple cancer.
(2) The patient who has history of multiple laparotomy.
(3) The patient who has critical complications.
(4) The patient who has merged the mental disease or the neurological manifestation and is judged that participation is difficult by research.
(5) The patient whom the principal investigator or the assignment researcher judged to be unsuitable to this research participation.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Kojima

Organization

Juntedo University Hospital

Division name

Coloproctological Surgery

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

yutachan@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Kojima

Organization

Juntedo University Hospital

Division name

Coloproctological Surgery

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

yutachan@juntendo.ac.jp


Sponsor or person

Institute

Dwpartment of Coloproctological Surgery, Juntedo University Hospital

Institute

Department

Personal name



Funding Source

Organization

Juntedo University Hospital

Organization

Division

Category of Funding Organization

Other

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

2014 Year 07 Month 01 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

Preinitiation

Date of protocol fixation

2014 Year 05 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 23 Day

Last modified on

2014 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016695


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name