UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030440 |
|---|---|
| Receipt number | R000015026 |
| Scientific Title | Safety and feasibility of robotic assisted hysterectomy |
| Date of disclosure of the study information | 2017/12/17 |
| Last modified on | 2021/07/09 17:21:39 |
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Basic information
Public title
Safety and feasibility of robotic assisted hysterectomy
Acronym
Safety and feasibility of robotic assisted hysterectomy
Scientific Title
Safety and feasibility of robotic assisted hysterectomy
Scientific Title:Acronym
Safety and feasibility of robotic assisted hysterectomy
Region
| Japan |
Condition
Condition
uterine disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of da Vinci surgical system as a tool for hysterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
anesthesia tie, operation time, hemorrhage during procedure, frequency of use of analgesic agents, dates of hospital stay
Key secondary outcomes
intra- and post-surgical complications, values of hemoglobin, white blood cell count and CRP, duration and extent of fever
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Those who possess uterine disorders including uterine fibroid, adenomyosis etc. and hope to be hysterectomized.
2) The uterine size should be smaller than new born head and the uterus can be excised by conventional laparoscopy.
3) Those who are able to obtain written informed consent.
Key exclusion criteria
1) Those who are are inadequate to participate in this study due to their complications.
2) Those who can not understand the purpose of this study, and unable to obtain written informed consent.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Osuga |
Organization
University of Tokyo
Division name
Department of Obstetrics and Gynecology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8657
yutakaos-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Hiraike |
Organization
University of Tokyo
Division name
Department of Obstetrics and Gynecology
Zip code
1138655
Address
7-3-1 hongo, Bunkyo-ku, Tokyo
TEL
03-5900-8657
Homepage URL
osamuwh-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
0358008657
osamuwh-tky@umin.ac.jp
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 | 17 | 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
| 2017 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015026
