UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040158 |
|---|---|
| Receipt number | R000045779 |
| Scientific Title | Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci Xi surgical system for uterine myoma and adenomyosis |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2023/04/20 15:40:49 |
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Basic information
Public title
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci Xi surgical system for uterine myoma and adenomyosis
Acronym
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy for uterine myoma and adenomyosis
Scientific Title
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci Xi surgical system for uterine myoma and adenomyosis
Scientific Title:Acronym
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy for uterine myoma and adenomyosis
Region
| Japan |
Condition
Condition
Uterine myoma, adenomyosis
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 uterine myoma and adenomyosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of surgical complication
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
robot-assisted hysterectomy using da Vinci surgical system for patients with uterine myoma and adenomyosis
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Patient is diagnosed as benign uterine disease (uterine myoma, adenomyosis) indicated for surgery.
We need to obtain written informed consent by the patient.
Key exclusion criteria
Patients with ineligible condition for robot assisted operation.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ohmichi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Gynecology
Zip code
5698686
Address
2-7, Dairaku-machi, Takatsuki city, Osaka
TEL
072-683-1221
m-ohmichi@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Medical and Pharmaceutical University
Division name
Gynecology
Zip code
5698686
Address
2-7, Dairaku-machi, Takatsuki city, Osaka
TEL
072-683-1221
Homepage URL
tomohito.tanaka@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University Clinical Research Review Board
Address
2-7, Dairaku-machi, Takatsuki city, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2020 | Year | 04 | 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
5
Results
Robot-assisted total hysterectomy was performed as planned for 5 cases of uterine fibroids.
No intraoperative or postoperative complications, no blood transfusion
The average operation time was 181.8 minutes and the console time was 114.4 minutes, both of which were completed within the scheduled time.
Results date posted
| 2023 | Year | 04 | Month | 20 | Day |
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
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045779
