UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030406 |
|---|---|
| Receipt number | R000034723 |
| Scientific Title | An evaluation study fo efficacy and safety ob Robotic total hysterectomy with Da vinci Surgical System for uterine cancer |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2017/12/15 11:16:29 |
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Basic information
Public title
An evaluation study fo efficacy and safety ob Robotic total hysterectomy with Da vinci Surgical System for uterine cancer
Acronym
An evaluation of uterine cancer total hysterectomy with Da vinci
Scientific Title
An evaluation study fo efficacy and safety ob Robotic total hysterectomy with Da vinci Surgical System for uterine cancer
Scientific Title:Acronym
An evaluation of uterine cancer total hysterectomy with Da vinci
Region
| Japan |
Condition
Condition
uterine corpus cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of total hysterectomy using Da Vinci Surgical System for uterine corpus cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative Morbidity and Mortality (Clavien-Dindo classification 2 or higher).
Key secondary outcomes
Surgical outcomes (operation time, volume of blood loss, and conversion rate to open surgery)
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
| Maneuver |
Interventions/Control_1
otal hysterectomy with 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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) histrogically and radiologically judged uterine cancer
2) applicable to video-assisted total hysterectomy
3) age 20 to 80 years
4) ECOG-Performance status of 0 to 1
5) written informed consent
Key exclusion criteria
1) severe cardiac or cerebral vascular disease
2) aspirin, warfarin or other medications induce bleeding tendency prohibited to discontinue
3) sever renal disfunction
4) severe hepatic disfunction
5) patients whose enrollement in this trial is judged to be inappropriate by the attending doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Hasuo |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gynecology
Zip code
Address
1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
hasuo@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Hasuo |
Organization
ational Hospital Organization Kyushu Medical Center
Division name
Department of Gynecology
Zip code
Address
1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
hasuo@kyumed.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 12 | Month | 15 | 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 | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034723
