UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015312 |
|---|---|
| Receipt number | R000017274 |
| Scientific Title | the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2021/10/06 09:34:47 |
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Basic information
Public title
the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Acronym
the study of utility and safety for robot-assisted laparoscopic radical hysterectomy
Scientific Title
the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Scientific Title:Acronym
the study of utility and safety for robot-assisted laparoscopic radical hysterectomy
Region
| Japan |
Condition
Condition
Uterine Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
"da Vinci S Surgical System" as robot assisted surgery device is safe, minimally invasive and stressless, so is suitable for complicated and delicate operation as radical hysterectomy. Our purpose of this study is to assess the utility and safety of this system for robot assisted laparoscopic radical hysterectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Intra-operative & post-operative complications
Key secondary outcomes
1. blood loss
2. the level of postoperative pain
3. the numaber of retrieved lymphnodes
4. operative time
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 hysterectomy.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
#1 Uterine cervical cancer, stage IA2-IIB (FIGO criteria)
#2 Good general status (Performance status 0-1)
Key exclusion criteria
#1 With double cancers
#2 With a history of pelvic radiotherapy
#3 With a history of a surgery in the pelvis
#4 Intolerant of general anesthesia
#5 Undergoing chemotherapy
#6 In pregnancy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tokunaga |
Organization
Tohoku University Hospital
Division name
Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
tokunagahideki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Zen |
| Middle name | |
| Last name | Watanabe |
Organization
Tohoku University
Division name
Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
Homepage URL
zenw5261@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
rinri-2@proj.med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017274
