UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000047387