UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029461 |
|---|---|
| Receipt number | R000033647 |
| Scientific Title | The evaluation for safety and efficacy of the robotic total hysterectomy using da Vinci surgical system |
| Date of disclosure of the study information | 2017/10/07 |
| Last modified on | 2023/04/13 09:42:48 |
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Basic information
Public title
The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Acronym
The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Scientific Title
The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Scientific Title:Acronym
The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Region
| Japan |
Condition
Condition
uterine cervical cancer, uterine corpus cancer,atypical endometrial hyperplasia, uterine myoma, uterine adenomyosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
blood loss
Key secondary outcomes
operation time,complications,
hospitalization,postsurgical pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
the robotic total hysterectomy 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
uterine cervical canncer,uteinr corpus cancer,atypical endometrial hyperplasia,myoma uteri and adenomyosis that requires surgery
Key exclusion criteria
inappropriate cases for laparoscopic surgeries due to severe endometriosis,severe obesity, severe intraabdominal adhesion and other factors
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Kitada |
Organization
Suita Tokushukai Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
5650814
Address
1-21,Senriokanishi,Suita city,Osaka
TEL
06-6878-1110
fuminori.kitada@tokushukai.jp
Public contact
Name of contact person
| 1st name | Fuminori |
| Middle name | |
| Last name | Kitada |
Organization
Suita Tokushukai Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
565-0814
Address
1-21,Senriokanishi,Suita city,Osaka
TEL
06-6878-1110
Homepage URL
fuminori.kitada@tokushukai.jp
Sponsor or person
Institute
Suita Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Suita Tokushukai Hospital
Organization
Division
Category of Funding Organization
Other
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
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
utsugi@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
吹田徳洲会病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
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 | 09 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 26 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033647
