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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025500
Receipt No. 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

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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
Obsterics 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
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
URL(English) https://upload.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


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