UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055855 |
|---|---|
| Receipt number | R000063837 |
| Scientific Title | Short- and Long-Term Safety and Efficacy of Robot-Assisted Rectal Surgery Using the da Vinci System Based on the Japanese Medical Data Vision Analysis |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/03/26 10:58:40 |
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Basic information
Public title
Study on the Safety and Efficacy of da Vinci-Assisted Rectal Surgery
Acronym
Safety and Efficacy of Robot-Assisted Rectal Surgery
Scientific Title
Short- and Long-Term Safety and Efficacy of Robot-Assisted Rectal Surgery Using the da Vinci System Based on the Japanese Medical Data Vision Analysis
Scientific Title:Acronym
A Study on da Vinci-Assisted Rectal Surgery (SVARS)
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using the big data registered in Medical Data Vision (MDV), this study aims to clarify the long-term safety and efficacy of rectal resection or rectal amputation performed with the da Vinci Surgical System, a robotic platform for endoscopic surgery, in patients with rectal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year overall survival rate, 5-year recurrence-free survival rate
Key secondary outcomes
1)The incidence rate and breakdown of complications registered with ICD-10 codes within 30 days after surgery, including:
Anastomotic leakage, peritonitis, intra-abdominal bleeding, bowel obstruction, surgical site infection, urinary retention, pneumonia, pulmonary thromboembolism, surgical wound infection, urinary tract infection, myocardial infarction, deep vein thrombosis, postoperative septic shock, ileus, and others.
2)Intraoperative blood transfusion rate
3)Postoperative length of hospital stay
4)Incidence rate of unplanned readmissions within 30 days after surgery
5)Incidence rate of reoperation within 30 days after surgery
6)Incidence rate of death within 30 and 90 days after surgery
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases registered in the MDV database where open, laparoscopic, or robot-assisted rectal resection/amputation was performed between April 1, 2018, and June 30, 2024.
Cases with a preoperative diagnosis of Stage I-III.
Cases where the admission diagnosis is registered as "C20 Malignant Neoplasm of the Rectum."
Cases that include preoperative radiation therapy and/or chemotherapy.
No age restrictions.
Key exclusion criteria
Cases with incomplete data.
Cases with an unknown preoperative stage.
Cases with a preoperative diagnosis of Stage IV.
Cases involving simultaneous surgery on other organs.
Target sample size
28500
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, Japan
TEL
03-5803-5254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Hanaoka |
Organization
Institute of Science Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
09050750189
Homepage URL
fujimarimarie@yahoo.co.jp
Sponsor or person
Institute
Institute of Science Tokyo
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
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035254
hanasrg1@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
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40922920/
Number of participants that the trial has enrolled
Results
RARR, LRR, and ORR groups had 3635 (15.3%), 17 142 (72.3%), and 2935 (12.4%) patients, respectively. Among the cohort (mean age: 69.5 years), 64.9% were male, and 24.7%, 31.5%, and 43.8% had clinical stages I, II, and III, respectively. The RARR group demonstrated the lowest postoperative complication rate, 30- and 90-day mortality rates, and shortest hospital stay. The RARR group had the highest 5-year OS (95%) and RFS (93%) compared to LRR (OS: 89%, RFS: 86%) and ORR (OS: 81%, RFS: 77%; p < 0.001).
Results date posted
| 2026 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 04 | Month | 15 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using the big data registered in Medical Data Vision (MDV), this study aims to elucidate the long-term safety and efficacy of rectal resection or rectal amputation for rectal cancer performed with the da Vinci Surgical System, a robotic platform for endoscopic surgery.
Primary Endpoint:
The 5-year overall survival rate and the 5-year recurrence-free survival rate.
Secondary Endpoints:
The incidence rate and breakdown of complications registered with ICD-10 codes within 30 days post-surgery, including: anastomotic leakage, peritonitis, intra-abdominal bleeding, bowel obstruction, surgical site infection, urinary retention, pneumonia, pulmonary thromboembolism, surgical wound infection, urinary tract infection, myocardial infarction, deep vein thrombosis, postoperative septic shock, ileus, and others.
The rate of intraoperative blood transfusion.
Postoperative length of hospital stay.
The incidence rate of unplanned readmissions within 30 days post-surgery.
The incidence rate of reoperation within 30 days post-surgery.
The incidence rate of mortality within 30 and 90 days post-surgery.
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063837
