UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032297 |
|---|---|
| Receipt number | R000036827 |
| Scientific Title | Clinical settingof robotic hysterectomy. |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2020/04/20 14:14:54 |
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Basic information
Public title
Clinical settingof robotic hysterectomy.
Acronym
Clinical settingof robotic hysterectomy.
Scientific Title
Clinical settingof robotic hysterectomy.
Scientific Title:Acronym
Clinical settingof robotic hysterectomy.
Region
| Japan |
Condition
Condition
benign uterine tumor
ensometrial cancer
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to estabrish minimaly invasive and reliably executing a husterectomy with daVinci cystem.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood loss
Key secondary outcomes
operation time
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
| Maneuver |
Interventions/Control_1
operation
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients were already diagnosed benign uterine tumor, endometrial cancer or cervical cancer.
2. Patients approve participation to the clinical research.
Key exclusion criteria
1. Patients with ineligible condition for robot assisted operation.
2. Patients who are not regarded appropriateness for robot assisted operation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Kyo |
Organization
Shimane University
Division name
Obstetrics and Gynecology
Zip code
693-8501
Address
Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL
0853-20-2268
satoruky@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakayama |
Organization
Shimane University
Division name
Obstetrics and Gynecology
Zip code
693-8501
Address
Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL
0853-20-2268
Homepage URL
kn88@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane 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
Bio Ethical Committee in Shimane University Hospital
Address
Enyacho 89-1, Izumo, Shimane, Japan 6938501
Tel
0853-20-2515
kenkyu@med.shimane-u.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
島根大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://rinken.shimane-u-tiken.jp/people/196
Publication of results
Unpublished
Result
URL related to results and publications
https://rinken.shimane-u-tiken.jp/people/196
Number of participants that the trial has enrolled
20
Results
The mean operating time of was short with in 6.5 hours in benign tumors and endometrial malignant tumors. In cervical malignant tumors, it was needed more than 6.5 hours, although anesthesists and responsible person of surgery made a judgmental decision and carried through surgery.In one case, estimated blood loss was massive and conversion to laparotomy.In other cases the mean estimated blood loss was very small amount and it was recognized the utility of robotic assisted surgery.
Results date posted
| 2020 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
benign gynecological tumor 5 cases
malignant gynecological tumor 5 cases
Participant flow
All patients entered clinical trial arm.
Adverse events
In one case, estimated blood loss were over 3000ml,so it was required blood transfusion and conversion to laparotomy.
Outcome measures
mean estimated blood loss
benign gynecological tumor 115ml
malignant gynecological tumor 725ml
mean operation time
benign gynecological tumor 218min
malignant gynecological tumor 416min
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 04 | Month | 18 | Day |
Last modified on
| 2020 | 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=R000036827
