UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039575 |
|---|---|
| Receipt number | R000037170 |
| Scientific Title | Safety and efficacy of rectal resection of robot using da Vinci Xi surgical system for cStage 0-2 rectal cancer. |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/03/10 11:04:46 |
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Basic information
Public title
Safety and efficacy of rectal resection of robot using da Vinci Xi surgical system for cStage 0-2 rectal cancer.
Acronym
Study on robot-assisted rectal resection in Tokyo Metropolitan Tama Medical Center.
Scientific Title
Safety and efficacy of rectal resection of robot using da Vinci Xi surgical system for cStage 0-2 rectal cancer.
Scientific Title:Acronym
Study on robot-assisted rectal resection in Tokyo Metropolitan Tama Medical Center.
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot-assisted rectal resection for rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraoperative and postoperative adverse events associated with surgery
Key secondary outcomes
Completion rate of robot-assisted surgery
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
| Maneuver |
Interventions/Control_1
robot-assisted 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Rectal cancer,PS 0-1,BMI less than 30,No uncontrolled complications
Key exclusion criteria
Active double cancer, pregnant or lactating women, severe complications, ongoing steroid treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Osaka |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
department of surgery
Zip code
184-8542
Address
2-8-29 Musashidai,Fuchu,Tokyo
TEL
042-323-5111
itaru_osaka@tmhp.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Osaka |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
department of surgery
Zip code
184-8542
Address
2-8-29 Musashidai,Fuchu,Tokyo
TEL
042-323-5111
Homepage URL
itaru_osaka@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai,Fuchu,Tokyo
Tel
042-323-5111
tamarinshou@tmhp.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
| 2020 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037170
| 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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