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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041517
Receipt No. 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

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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
Email 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
Email matsuyama.srg1@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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