UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059709 |
|---|---|
| Receipt number | R000068240 |
| Scientific Title | Outcomes of robot-assisted versus conventional laparoscopic right hemicolectomy for colon cancer: a propensity-matched analysis of the National Clinical Database in Japan |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 01:19:28 |
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Basic information
Public title
Outcomes of robot-assisted versus conventional laparoscopic right hemicolectomy for colon cancer: a propensity-matched analysis of the National Clinical Database in Japan
Acronym
NCD RoRHC study
Scientific Title
Outcomes of robot-assisted versus conventional laparoscopic right hemicolectomy for colon cancer: a propensity-matched analysis of the National Clinical Database in Japan
Scientific Title:Acronym
NCD RoRHC study
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the safety and efficacy of robot-assisted right hemicolectomy for colonic malignancies using big data from the National Clinical Database (NCD). Furthermore, we will analyze the learning curve of robot-assisted right hemicolectomy and evaluate perioperative outcomes of robot-assisted surgery for colonic malignancies based on cases registered in the NCD Robot Registry.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of all postoperative complications of Clavien Dindo grade II or higher within 30 days after surgery
Key secondary outcomes
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 underwent conventional laparoscopic or robot-assisted right hemicolectomy between January 1, 2023 and December 31, 2024, and were registered in the National Clinical Database (NCD).
2. Cases in which the admission diagnosis was recorded as C189 Malignant neoplasm of colon.
3. Cases that received preoperative chemotherapy are included.
4. No age restriction was applied.
Key exclusion criteria
None
Target sample size
14000
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Institute of Science Tokyo
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 | Sakiko |
| Middle name | |
| Last name | Oba |
Organization
Institute of Science Tokyo Department of Gastrointestinal Surgery
Division name
Department of Gastrointestinal Surgery
Zip code
113-0001
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
08012836251
Homepage URL
asano.sakiko@tmd.ac.jp
Sponsor or person
Institute
The Japanese Society of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo Institutional Review Board for Medical Research
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel
03-5803-5254
rinri.adm@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068240
