UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041517 |
|---|---|
| Receipt number | R000047387 |
| Scientific Title | The safety and efficacy of laparoscopic rectal surgery with endoscopic surgery support robot (da Vinci): National Clinical Database analysis |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/02/21 12:56:14 |
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Basic information
Public title
The safety and efficacy of laparoscopic rectal surgery with endoscopic surgery support robot (da Vinci): National Clinical Database analysis
Acronym
NCD_RoRecS
Scientific Title
The safety and efficacy of laparoscopic rectal surgery with endoscopic surgery support robot (da Vinci): National Clinical Database analysis
Scientific Title:Acronym
NCD_RoRecS
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 low anterior resection with endoscopic surgery support robot (da Vinci surgical system) for rectal malignant tumor, using National clinical database (NCD) in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of the conversion to open surgery
Key secondary outcomes
1) Incidence of postoperative complications within 30 days after surgery (CD classification grade II or more)
2) Incidence of postoperative complications within 30 days after surgery
3) Incidence of reoperation/ readmission within 30 days after surgery
4) Mortality/ in-hospital mortality within 30 days after surgery
5) Surgical outcomes (Estimate blood loss, Total operative time, etc.)
6) Incidence of intraoperative adverse effects
7) Incidence of intraoperative organ injury
8) Postoperative recovery (Length of postoperative hospital stay, etc.)
9) Learning curve of robot-assisted surgery
10) Perioperative outcomes of robot-assisted surgery for rectal malignancies
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have undergone conventional laparoscopic or robot-assisted low anterior resection between January 1, 2018 and December 31, 2019, and who are enrolled in NCD
2) Patients registered as "C20 malignant neoplasm of rectum <tumor>"
3) Including patients who received preoperative radiation therapy and chemotherapy
4) Any age
Key exclusion criteria
None
Target sample size
10700
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | Matsuyama |
| Last name | Matsuyama |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5254
Homepage URL
matsuyama.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Intuitive Surgical Sarl
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Switzerland
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel
03-3813-6111
info.bec@tmd.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
名古屋大学（愛知県）
札幌医科大学（北海道）
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | 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
| 2020 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study (propensity score analysis for conventional laparoscopic low anterior resection and robot-assisted lower anterior resection enrolled in NCD from January 1, 2018 to December 31, 2019 ).
Management information
Registered date
| 2020 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047387
| 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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