UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018300 |
|---|---|
| Receipt number | R000020932 |
| Scientific Title | examination of effectiveness and safety for robot-assisted laparoscopic radical hysterectomy (RALRH) for the patient with uterine cervical cancer |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2019/01/09 10:06:52 |
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Basic information
Public title
examination of effectiveness and safety for robot-assisted laparoscopic radical hysterectomy (RALRH) for the patient with uterine cervical cancer
Acronym
examination of RALRH for uterine cervical cancer
Scientific Title
examination of effectiveness and safety for robot-assisted laparoscopic radical hysterectomy (RALRH) for the patient with uterine cervical cancer
Scientific Title:Acronym
examination of RALRH for uterine cervical cancer
Region
| Japan |
Condition
Condition
uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our purpose of this study is to assess the efficacy and safety of robot assisted laparoscopic radical hysterectomy for the patient of uterine cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
blood loss
Key secondary outcomes
operative time
consol time
number of resected lymphnodes
appropriateness of resected organ
rate of transfusion
urinary function
complications
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
We perform robot-assisted laparoscopic radical hysterectomhy for the patient with uterin cervical cancer.
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
Uterine cervical cancer, stage IA2-IIB (FIGO criteria)
Generally good status (Performance status 0-2)
Be agreed by the patient
Key exclusion criteria
The condition of having severe complecation (for example coronary heart disease,arrythmia,diabetes,liver failure,renal failure,glaucoma)Possibility of infection
Judged unsuitable by researchers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukuru Amano |
Organization
Shiga medical university
Division name
obstetrics and gynecology
Zip code
Address
Tsukinowacho Seta Ootsu City
TEL
0775482267
tsukuru@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukuru Amano |
Organization
Shiga medical university
Division name
obstetrics and gynecology
Zip code
Address
Tsukinowacho Seta Ootsu City
TEL
0775482267
Homepage URL
tsukuru@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Shiga medical university hospitalh
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
滋賀医科大学病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
| 2015 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020932
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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