UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037252 |
|---|---|
| Receipt number | R000042237 |
| Scientific Title | Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2021/01/08 11:44:41 |
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Basic information
Public title
Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Acronym
Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Scientific Title
Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Scientific Title:Acronym
Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Region
| Japan |
Condition
Condition
early stage of carcinoma of the corpus uteri
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to introduce robot-assisted laparoscopic surgery, which is a minimally invasive medical treatment for patients with carcinoma of the corpus uteri, and to meet the institution standard (conducted 10 cases) where insurance medical treatment can be performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of safe and radically secured robot-assisted laparoscopic surgery for carcinoma of the corpus uteri.Evaluate at the end of 10 cases.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Robot surgery, one day
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Endometrial cancer stage I
Key exclusion criteria
Patients who have radiation therapy in the upper abdomen.
Patients who can not obtain consent for the operation.
Patients who do not get approval at the robot-assisted surgery case review meeting.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Mikoshiba |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Obstetrics and Gynecology
Zip code
2308765
Address
3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
TEL
045-576-3000
t_mikoshiba@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Mikoshiba |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Obstetrics and Gynecology
Zip code
2308765
Address
3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
TEL
045-576-3000
Homepage URL
t_mikoshiba@tobu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Tobu Hospital
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
Saiseikai Yokohamashi Tobu Hospital
Address
3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
Tel
045-576-3000
t_mikoshiba@tobu.saiseikai.or.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
済生会横浜市東部病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042237
