UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004827
Receipt number R000005746
Scientific Title Study of Robot-assisted Surgery for rectal tumor
Date of disclosure of the study information 2011/01/06
Last modified on 2017/07/12 16:15:08

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Basic information

Public title

Study of Robot-assisted Surgery for rectal tumor

Acronym

Study of Robot-assisted Surgery for rectal tumor

Scientific Title

Study of Robot-assisted Surgery for rectal tumor

Scientific Title:Acronym

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

1st name
Middle name
Last name Daisuke Kuroda

Organization

Kobe University

Division name

Department of Surgery

Zip code


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

1st name
Middle name
Last name Yasuo Sumi

Organization

Kobe University

Division name

Department of Surgery

Zip code


Address

7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan

TEL

078-382-5925

Homepage URL


Email

sumiy@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



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)



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

2011 Year 01 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

2011 Year 01 Month 06 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005746


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name