UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030134 |
|---|---|
| Receipt number | R000033867 |
| Scientific Title | The safety and efficacy of extended or partially extended hysterectomy assisted by the da Vinci Surgical System. |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2024/01/11 09:11:47 |
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Basic information
Public title
The safety and efficacy of extended or partially extended hysterectomy assisted by the da Vinci Surgical System.
Acronym
Robot-assisted radical hysterectomy
Scientific Title
The safety and efficacy of extended or partially extended hysterectomy assisted by the da Vinci Surgical System.
Scientific Title:Acronym
Robot-assisted radical hysterectomy
Region
| Japan |
Condition
Condition
Cervical cancer.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot-assisted total hysterectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood loss, operation time, intraoperative and postoperative complication, and hospital stay.
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
da Vinci Surgical System 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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
Cervical cancer stage IA-IIB
Key exclusion criteria
Patients who are not recommend for study enrollment, judged by medical attendants.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Gynecology
Zip code
274-8503
Address
2-11-1 Takanedai,Funabashi-shi,Chiba Japan
TEL
047-466-7111
hrssasaki0226@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Gynecology
Zip code
274-8503
Address
2-11-1 Takanedai, Funabashi-shi, Chiba Japan
TEL
047-466-7111
Homepage URL
hrssasaki0226@gmail.com
Sponsor or person
Institute
CHIBA TOKUSHUKAI HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
CHIBA TOKUSHUKAI HOSPITAL
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
The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address
Emina Building 3F,1-8-7 Koji-machi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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 | 07 | 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
7
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033867
