UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022609 |
|---|---|
| Receipt number | R000026060 |
| Scientific Title | The clinical study of robotic assisted surgery for Gynecologic Oncology |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2023/06/11 23:58:46 |
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Basic information
Public title
The clinical study of robotic assisted surgery for Gynecologic Oncology
Acronym
The clinical study of robotic assisted surgery for Gynecologic Oncology
Scientific Title
The clinical study of robotic assisted surgery for Gynecologic Oncology
Scientific Title:Acronym
The clinical study of robotic assisted surgery for Gynecologic Oncology
Region
| Japan |
Condition
Condition
cervical cancer(IA1.IA2),endometrial cancer(IA.IB),atypical endometrial hyperplasia, uterine myoma, uterine adenomyosis,cervical dysplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility and safety of robot-assisted surgery for gynecologic oncology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Anesthesia time, operative time, blood loss, intraoperative and postoperative complications, postoperative pain 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 |
Interventions/Control_1
Robot-assisted surgery for gynecologic oncology
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
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
uterine myoma,uterine adenomyosis
Atypical endometrial hyperplasia
cervical dysplasia
Endometrial cancer FIGO stage IA.IB
Cervical cancer FIGO stage IA1.IA2
Key exclusion criteria
Patients who are not recommended for laparoscopic surgery or study enrollment because of complications and other factors
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Aoki |
Organization
Keio University Scool of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
shigenorih1974@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Hayashi |
Organization
Keio University Scool of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
Homepage URL
shigenorih1974@keio.jp
Sponsor or person
Institute
Keio University Scool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University Scool of Medicine
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 | 06 | Month | 06 | 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
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | 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 | 06 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026060
