UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009653 |
|---|---|
| Receipt number | 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 10:40:26 |
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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
| Obstetrics 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
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
uskichi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
