UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025500
Receipt number R000029346
Scientific Title The study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci surgical system
Date of disclosure of the study information 2017/01/05
Last modified on 2018/07/10 15:10:23

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Basic information

Public title

The study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci surgical system

Acronym

robot-assisted laparoscopic radical hysterectomy

Scientific Title

The study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci surgical system

Scientific Title:Acronym

robot-assisted laparoscopic radical hysterectomy

Region

Japan


Condition

Condition

Uterine cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The object of this study is to assess the utility and safety of robot-assisted laparoscopic radical hysterectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

success operation rate using robot surgical system

Key secondary outcomes

intra- and post- operative complications
relapse-free survival
over-all survival
postoperative QOL


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

robot-assisted laparoscopic radical hysterectomy

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

Female

Key inclusion criteria

#1 Uterine cervical cancer, stage IA2, IB1, 2A1
#2 Good general status (performance status 0-1)

Key exclusion criteria

#1 With active double cancers
#2 With an obvious lymph node swelling(short diameter>10mm)
#3 With an enlarged uterus which is needed for
morcerllation
#4 With a history of major abdominal surgery
#5 With a history of radiotherapy for pelvis
#6 With an angle-closure glaucoma

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name SHOJI KAMIURA

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gynecology

Zip code


Address

1-3-3 Nakamichi, Higasinari-ku, Osaka

TEL

06-6972-1181

Email

kamiura-sh@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name SHOJI KAMIURA

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gynecology

Zip code


Address

1-3-3 Nakamichi, Higasinari-ku, Osaka

TEL

06-6972-1181

Homepage URL


Email

kamiura-sh@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

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

2017 Year 01 Month 05 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

2016 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 05 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

2017 Year 01 Month 03 Day

Last modified on

2018 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029346


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name