UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057656 |
|---|---|
| Receipt number | R000065879 |
| Scientific Title | A multicenter, retrospective, observational study of the utility of the Hugo RAS system in robot-assisted colorectal surgery |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2026/04/19 10:52:35 |
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Basic information
Public title
A multicenter, retrospective, observational study of the utility of the Hugo RAS system in robot-assisted colorectal surgery
Acronym
A multicenter, retrospective, observational study of the utility of the Hugo RAS system in robot-assisted colorectal surgery
Scientific Title
A multicenter, retrospective, observational study of the utility of the Hugo RAS system in robot-assisted colorectal surgery
Scientific Title:Acronym
A multicenter, retrospective, observational study of the utility of the Hugo RAS system in robot-assisted colorectal surgery
Region
| Japan |
Condition
Condition
colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the HugoT RAS system in robot-assisted colorectal surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient background, preoperative diagnosis, preoperative treatment, surgical results, pathology results, short-term results, long-term results
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are at least 18 years of age
2) Patients who have undergone robot-assisted colorectal surgery using the Hugo RAS system
Key exclusion criteria
1) Patients who have requested not to participate in this study by submitting a publicly available opt-out document
2) Other patients who have undergone another procedure other than robot-assisted colorectal surgery using the Hugo RAS system, or who are deemed inappropriate by the principal investigator or subinvestigators.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Okuya |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
okuya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Miyo |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
Homepage URL
mmiyo@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university hospital institutional review board
Address
291, South1 West16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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 | 04 | Month | 21 | 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
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065879
