UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039685 |
|---|---|
| Receipt number | R000045179 |
| Scientific Title | Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2022/09/07 21:50:54 |
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Basic information
Public title
Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study
Acronym
VITRUVIANO trial
Scientific Title
Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study
Scientific Title:Acronym
VITRUVIANO trial
Region
| Japan |
Condition
Condition
advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the oncological feasibility on robot-assisted surgery for advanced rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of CRM-negative
Key secondary outcomes
Quality of TME
successful resection (CRM-negative, DM-negative and complete TME)
Conversion to open surgery
Intraoperative adverse effects
Surgical outcomes (estimate blood loss, operative time, console time, number of lymph nodes harvested)
Postoperative recovery of bowel function (time to first flatus/ stools/ intake of fluid and diet)
Postoperative urinary function (residual urine volume/ I-PSS/ OABSS/ ICIQ-SF)
Length of postoperative hospital stay
Postoperative complications within 30 days after surgery (Clavien-Dindo classification grade III or more)
Surgery-related mortality within 30 days after surgery
Reoperation within 30 days after surgery
3-year local recurrence-free survival
3-year disease-free survival
3-year overall survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed with rectal cancer
2) Diagnosed operable by preoperative examination and image diagnosis method
3) Tumor lower margin is less than or equal to 12 cm from the anal verge
4) Tumor location is rectosigmoid (RS), upper rectum (Ra), lower rectum (Rb), proctodeum (P)
5) "cT2-T4a and cN0-N3 and cM0" or "cT1-T4a and cN1-N3 and cM0" (Evaluate before preoperative treatment if patients will undergo preoperative treatment)
6) Diagnosed as not applicable for endoscopic resection
7) Scheduled for robot-assisted rectal resection in routine medical care (Informed consent has been obtained)
8) 20 years or older
9) Written informed consent for participation in this study has been obtained
Key exclusion criteria
1) cT4b
2) Multiple rectal cancer (except Tis)
3) Multiple malignancies
4) Patients whose consent ability is judged to be insufficient (dementia etc.)
5) Other, patients judged inappropriate by investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University Hospital
Division name
Department of surgery, surgical oncology and science
Zip code
060-8543
Address
291, South1 West16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hamabe |
Organization
Sapporo Medical University Hospital
Division name
Department of surgery, surgical oncology and science
Zip code
060-8543
Address
291, South1 West16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
ahamabe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Department of surgery, surgical oncology and science
Institute
Department
Personal name
Funding Source
Organization
Intuitive Surgical, Sarl
Organization
Division
Category of Funding Organization
Profit organization
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
札幌医科大学附属病院（北海道）、岩手医科大学附属病院（岩手県）、厚生連高岡病院（富山県）、東京都立駒込病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、国立がん研究センター中央病院（東京都）、がん研有明病院（東京都）、横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、静岡県立静岡がんセンター（静岡県）、藤田医科大学病院（愛知県）、名古屋大学医学部附属病院（愛知県）、大阪大学医学部附属病院（大阪府）、近畿大学病院（大阪府）、兵庫医科大学病院（兵庫県）、福岡大学病院（福岡県）、大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 04 | 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 | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Assessment for CRM negative rate
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045179
