UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017022
Receipt number 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 14:20:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Toyohashi municipal hospital

Institute

Department

Personal name



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

Value
https://center6.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