UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022278 |
|---|---|
| Receipt number | R000025670 |
| Scientific Title | Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS) |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2020/02/16 13:49:22 |
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Basic information
Public title
Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS)
Acronym
Robot-assisted radical hysterectomy
Scientific Title
Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS)
Scientific Title:Acronym
Robot-assisted radical hysterectomy
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this Study is to assess the efficacy and safety of robotic-assisted radical hysterectomy using DVSS for cervical cancer patient that can be curative. This Study is designed as the Advanced Medical Treatment/Technology Assessment Program B to provide the Clinical Study Report (CSR) based on the primary analysis, for the purpose of regulatory submission to MHLW for the national health insurance technology price listing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
success operation with a little blood loss
Key secondary outcomes
the operation time, the console time, No. of lymph nodes resected, the appropriateness of extracted specimen, the ratio of blood transfusion, the reserve ratio of autologous blood, the urinary function, the success rate of robot-assisted radical hysterectomy, the rate of conversion to laparotomy, postoperative courses (onset of postoperative oral ingest, duration of postoperative hospital stay), postoperative QOL measured by EQ-5D, overall survival, relapse-free survival, the occurrence of perioperative adverse events, the occurrence of postoperative adverse events, the occurrence of late adverse events, the defect failure of DVSS
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
| Device,equipment |
Interventions/Control_1
use of the robot for endoscopic 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
cervical cancer (squamous cell carcinoma FIGO Stages IB1 - llB , or adenocarcinoma FIGO Stages IA2 - IIB without metastasis of lymph nodes and intracorporeal organs)
Key exclusion criteria
1) patients having an active double cancer
2) a woman who become pregnant or may become pregnant, or a nursing woman
3) patients with mental disorders
4) morbid obese patients (Body Mass Index: BMI >= 35)
5) patients received neoadjuvant chemotherapy
6) patients that it was judged that it was inadequate to participate in this study due to others
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Isaka |
Organization
Tokyo Medical University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
isaka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Nakamichi |
Organization
Tokyo Medical University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
n-kaori@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University 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
Tokyo Medical University Hospital
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3351-6141
d-irinri@tokyo-med.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
| 2016 | Year | 05 | Month | 11 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2020 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025670
