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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009653
Receipt No. R000011329
Scientific Title the study of utility and safety for robotassisted laparoscopic hysterectomy and pelvic lymphadenectomy using da Vinci S surgical system
Date of disclosure of the study information 2012/12/28
Last modified on 2014/03/27

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Basic information
Public title the study of utility and safety for robotassisted laparoscopic hysterectomy and pelvic lymphadenectomy using da Vinci S surgical system
Acronym the study of utility and safety for robotassisted laparoscopic hysterectomy and pelvic lymphadenectomy
Scientific Title the study of utility and safety for robotassisted laparoscopic hysterectomy and pelvic lymphadenectomy using da Vinci S surgical system
Scientific Title:Acronym the study of utility and safety for robotassisted laparoscopic hysterectomy and pelvic lymphadenectomy
Region
Japan

Condition
Condition Uterine body cancer and uterine cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 da Vinci S Surgical System is very useful system and it was approved for medical instruments November 2009 in Japan. Our porpose of this study is to study the utility and safety of this system for robot assisted laparoscopic hysterectomoy and lymph adenectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.blood loss
2.complication during operation and after operation
3.the level of pain after operation
Key secondary outcomes 1.number of lymph nodes
2.operation time
3.recurrence rate

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 We perform robot assisted laparoscopic hysterectomy and lymphadenectomy using da Vinci surgical system.
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
70 years-old >=
Gender Female
Key inclusion criteria Uterine Body cancer stage IA (FIGO criteria)

Uterine cervical cancer stage IA1(FIGO criteria)
Key exclusion criteria bad general condition
(performance status 2-4)
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Niikura
Organization Tohoku University Hospital
Division name gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7254
Email niikura@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Utsunomiya
Organization Tohoku University
Division name gynecology
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7253
Homepage URL http://www.ob-gy.med.tohoku.ac.jp/index.html
Email uskichi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2012 Year 12 Month 28 Day

Related information
URL releasing protocol https://www.rinri.med.tohoku.ac.jp/esct/Apply/project.aspx
Publication of results Unpublished

Result
URL related to results and publications https://www.rinri.med.tohoku.ac.jp/esct/Apply/project.aspx
Number of participants that the trial has enrolled
Results
We performed ten operation using Da Vinci Surgical system. We found little hemorrhage and short stay at hospital, but there was no significant result because of small numbers of cases.
In addition, there were no changes about the complications of during and after surgery, which were injury for tissues, infection, hernia, thrombosis, pain, etc.
 Meanwhile, operation time was prolonged about one to two hours.
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 Completed
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2014 Year 03 Month 05 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2012 Year 12 Month 27 Day
Last modified on
2014 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011329

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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