UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009533 |
|---|---|
| Receipt number | R000011194 |
| Scientific Title | Implementation and evaluation of robot-assisted surgery for gynecological disorders |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2013/12/12 13:52:26 |
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Basic information
Public title
Implementation and evaluation of robot-assisted surgery for gynecological disorders
Acronym
Implementation and evaluation of robot-assisted surgery for gynecological disorders
Scientific Title
Implementation and evaluation of robot-assisted surgery for gynecological disorders
Scientific Title:Acronym
Implementation and evaluation of robot-assisted surgery for gynecological disorders
Region
| Japan |
Condition
Condition
gynecological diseases, such as uterine leiomyoma, uterine adenomyosis, endometrial cancer (state I), cervical cancer (stage I), other uterine tumor, and benign ovarian tumor.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of endological surgery using da Vinci S Surgical System
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
operation time, hemorrhage volume, complication, recovery period, postoperative pain, histology, adverse event
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
robot-assisted surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) benign uterine tumor
2) endometrial cancer stage 0-I
3) cervical cancer stage 0-I
4) other uterine tumor
5) benign ovarian cancer
6) ECOG-PS 0-1
Key exclusion criteria
1) morbid obesity
2) large tumor mass
3) after radiation therapy in pelvic cavity
4) severe cardio- or cerebro-vascular disease
5) severe liver failure
6) severe renal failure
7)bleeding tendency
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Toki |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Gynecology
Zip code
Address
1-5-1,Tujidoukandai,Fujisawa-City,Kanagawa,251-0041,Japan
TEL
0466-35-1177
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Toki |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Gynecology
Zip code
Address
1-5-1,Tujidoukandai,Fujisawa-City,Kanagawa,251-0041,Japan
TEL
0466-35-1177
Homepage URL
Sponsor or person
Institute
Shounan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
医療法人徳洲会 湘南藤沢徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | 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
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
| 2012 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2013 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011194
