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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032297
Receipt No. R000036827
Scientific Title Clinical settingof robotic hysterectomy.
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/18

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Basic information
Public title Clinical settingof robotic hysterectomy.
Acronym Clinical settingof robotic hysterectomy.
Scientific Title Clinical settingof robotic hysterectomy.
Scientific Title:Acronym Clinical settingof robotic hysterectomy.
Region
Japan

Condition
Condition benign uterine tumor
ensometrial cancer
cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to estabrish minimaly invasive and reliably executing a husterectomy with daVinci cystem.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood loss
Key secondary outcomes operation time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 operation
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
75 years-old >=
Gender Female
Key inclusion criteria 1. Patients were already diagnosed benign uterine tumor, endometrial cancer or cervical cancer.
2. Patients approve participation to the clinical research.
Key exclusion criteria 1. Patients with ineligible condition for robot assisted operation.
2. Patients who are not regarded appropriateness for robot assisted operation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Kyo
Organization Shimane University
Division name Obstetrics and Gynecology
Zip code
Address Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL 0853-20-2268
Email satoruky@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Nakayama
Organization Shimane University
Division name Obstetrics and Gynecology
Zip code
Address Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL 0853-20-2268
Homepage URL
Email kn88@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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 島根大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 12 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
2018 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036827

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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