UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021017 |
|---|---|
| Receipt number | R000024255 |
| Scientific Title | Validation study to evaluate efficacy and safety of robot-assisted hysterectomy in Kanazawa University Hospital. |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2023/08/29 08:59:22 |
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Basic information
Public title
Validation study to evaluate efficacy and safety of robot-assisted hysterectomy in Kanazawa University Hospital.
Acronym
Validation study to evaluate efficacy and safety of robot-assisted hysterectomy in Kanazawa University Hospital.
Scientific Title
Validation study to evaluate efficacy and safety of robot-assisted hysterectomy in Kanazawa University Hospital.
Scientific Title:Acronym
Validation study to evaluate efficacy and safety of robot-assisted hysterectomy in Kanazawa University Hospital.
Region
| Japan |
Condition
Condition
Benign uterine disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of robot-assisted hysterectomy against benign uterin disease in Kanazawa Univ. Hospital.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of complication during surgery
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Robot-assisted 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
| Not applicable |
Gender
Female
Key inclusion criteria
Patient is diagnosed as benign uterine disease indicated for surgery.
We need to obtain written informed consent by the patient.
Patient condition is acceptable for general anesthesia.
Key exclusion criteria
Patient has psycological disorder unacceptable to participate in the trial.
Patient underwent multiple abdominal surgery previously.
Patient has present hystory of:Glaucoma,rise in intracranial pressure,cerebrovascular disorder,COPD,mitral valve insufficiency,severe obese BMI over30
When the physician determined the patient is inadequate for the trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunari Mizumoto |
Organization
Kanazawa Univ. Hospital
Division name
Dept. of OB/GYN
Zip code
Address
13-1 Takara-machi Kanazawa-si Ishikawa-ken Japan
TEL
076-265-2425
sanpu@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunari Mizumoto |
Organization
Kanazawa Univ. Hospital
Division name
Dept. of OB/GYN
Zip code
Address
13-1 Takara-machi Kanazawa-si Ishikawa-ken Japan
TEL
076-265-2425
Homepage URL
yas1025@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Dept. of OB/GYN,Kanazawa Univ. Hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
| 2016 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024255
